Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients
Official Title
A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients
Acronym
OMS115102
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2008
Primary Completion Date
May 2010Actual
Completion Date
Oct 2011Actual
First Submitted Date
Mar 18, 2008
First Submission Date that Met QC Criteria
Mar 18, 2008
First Posted Date
Mar 21, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 1, 2012
Results First Submitted that Met QC Criteria
Dec 3, 2012
Results First Posted Date
Dec 4, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 13, 2017
Last Update Posted Date
Apr 11, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.
Detailed Description
The trial consists of two phases, a 48 week treatment period, followed by an individualized treatment period of up to two years.
Patients are treated in cohorts of increasing doses (100 mg, 300 mg and 700 mg) with 12 patients in each dose cohort. Within each cohort patients are randomized asymmetrically in a 2:1 ratio such that eight patients will receive ofatumumab and four patients will receive placebo. After 24 weeks the patients randomized to placebo will be treated with the active dose for the cohort. For blinding purposes, patients randomized to the active dose will be treated with placebo after 24 weeks. Thus, each patient will receive two administrations of trial product with 24 weeks follow-up resulting in a total treatment period of 48 weeks duration. An Independent Data Monitoring Committee (IDMC) will review and evaluate the safety data of each cohort, a minimum of 4 weeks data including the week 4 Magnetic Resonance Imaging (MRI) from at least 10 patients, to consider if progression to the next higher dose cohort is acceptable.
The trial product is administered as two infusions separated by two weeks. Clinical assessment and Gadolinium enhanced (Gd-enhanced) MRI scan will be performed at weeks -4, 0, 2, 4, and every 4 weeks until week 48. The MRI scan at week 2 is carried out for safety assessment prior to administering the second infusion in the first treatment course. When patients in all dose cohorts have been dosed and have had week 4 MRI scans performed, an IDMC will review all available safety data.
After completion of week 48 patients will be followed to monitor B-cell and IgG normalization. B-cell levels will be monitored every 12 weeks until CD19+ cells have returned to baseline level (Visit 3) or normalized level. If the B-cell levels are not normalized after two years the patient should be followed until either the IgG or the B-cell levels are normalized (see Section 9.2.4 for details). During this period Gd-enhanced MRI follow up scans will be performed every 12 weeks to evaluate potential rebound, safety and for Progressive Multifocal Leukoencephalopathy (PML) monitoring.
Conditions Module
Conditions
Multiple Sclerosis
Keywords
relapsing forms of multiple sclerosis
ofatumumab
multiple sclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
38Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1.1
Experimental
100mg ofatumumab then placebo
Drug: Ofatumumab 100
Drug: Placebo
Cohort 1.2
Experimental
placebo then 100mg ofatumumab
Drug: Ofatumumab 100
Drug: Placebo
Cohort 2.1
Experimental
300mg ofatumumab then placebo
Drug: Ofatumumab 300
Drug: Placebo
Cohort 2.2
Experimental
placebo then 300mg ofatumumab
Drug: Ofatumumab 300
Drug: Placebo
Cohort 3.1
Experimental
700mg ofatumumab then placebo
Drug: Ofatumumab 700
Drug: Placebo
Cohort 3.2
Experimental
placebo then 700mg ofatumumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ofatumumab 100
Drug
100mg
Cohort 1.1
Cohort 1.2
Ofatumumab 300
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Adverse Event
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section. Non-serious AEs were not collected during the Individualized Follow-up Period.
First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Number of Participants With the Indicated Critical Adverse Events (CAEs)
A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.
Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)
Number of Participants With Abnormal Physical Examination Findings
Secondary Outcomes
Measure
Description
Time Frame
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. "Total T1 enhancing Ls" represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria
Patients with:
At least two confirmed relapses within the last 24 months or
At least one confirmed relapse within the last 12 months or
One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening.
Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening
Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase
Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period
Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
Exclusion Criteria:
Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS) or Progressive Relapsing Multiple Sclerosis (PRMS) or Neuromyelitis optica
Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML
Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS
Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access
Patients who have had the following treatments:
Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-Cluster of Differentiation (CD4), cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time
Anti-CD20 treatments or any monoclonal antibodies at any time
Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and Interferon Beta (IFN-b).
Glatiramer Acetate or IFN-b within three months prior to the randomization in the trial.
Glucocorticoids or Adrenocorticotropic Hormone (ACTH) within one month prior to the screening in the trial.
Receipt of a live vaccine within one month prior to screening in the trial.
Plasmapheresis for treatment of relapses within 2 months prior to randomization in the trial.
Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial.
Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the sponsors medical monitor
Past or current history of medically significant adverse effects (including allergic reactions) from:
Cetirizine
Prednisolone
Paracetamol/acetaminophen
Plasma proteins or a known hypersensitivity to components of the investigational product.
Past or current malignancy, except for
Cervical carcinoma Stage 1B or less
Non-invasive basal cell and squamous cell skin carcinoma
Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response
Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy.
Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subject's health (i.e. acute ischemia, left bundle branch or bifascicular block)
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric or neurological disease which may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
History of severe, clinically significant Central Nervous System (CNS) trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease
Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C. Any previous serious infections should be discussed with the sponsors medical monitor (e.g. opportunistic or atypical infections)
Female patients who are pregnant or nursing.
Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed with the medical monitor.
Current participation in any other interventional clinical trial. Participation in non-interventional trial requires approval of the protocol by the sponsor
Serum vitamin B12 below lower limit of normal
Positive polymerase chain reaction (PCR) screening for John Cunningham Virus (JC Virus) as measured by qualitative plasma and/or white blood cell JCV DNA
Serologic evidence of Hepatitis B (HB) infection based on the results of testing for Hepatitis B Surface Antigen (HBsAg), anti- Hepatitis B Core (HBc) and anti- Hepatitis B Surface (HBs) antibodies with eligibility based on the results as follows:
Patients positive for HBsAg are excluded
Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible
Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody (indicating past vaccination) are eligible
Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA, which if positive will exclude the patient from participation
Patient with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered eligible for the trial.
Positive serology for HIV
Screening laboratory values:
White Blood Cell (WBC) < 3.0 x 109/L
Neutrophils < 2 x 109/L
Platelets < 100 x 109/L
Circulating IgG level < lower limit of normal (according to central laboratory range)
Serum Alanine Aminotransferase (S-ALAT) > 2.5 times the upper limit of normal (according to central laboratory range)
Serum Alpha Fetoprotein (S-AP) > 2.0 times the upper limit of normal (according to central laboratory range)
Serum Aspartate Aminotransferase (ASAT) >3.0 times the upper limit of normal (according to central laboratory range)
Bilirubin > 1.5 times the upper limit of normal (according to central laboratory range)
S-creatinine > the upper limit of normal (according to central laboratory range)
CD4 count <500 cells/mm3, CD4:CD8 <0.9
Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
Positive test for Hepatitis C antibody confirmed with a Hepatitis C real time (RT) PCR assay.
Patients who are positive for Hepatitis C antibody and negative when the Hepatitis C RT PCR assay is performed will be eligible for the study. Patients who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RT PCR assay is performed will not be eligible for the study.
Positive test results for tuberculosis using the QuantiFERON test and/or Chest X-ray findings suggestive of tuberculosis (TB). For patients who have had a Chest X-ray performed within the past 6 months without any findings indicative of TB, QuantiFERON test alone may be performed.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
In all 3 dose cohorts, participants in the active/placebo group received treatment with ofatumumab during the First Treatment Period and placebo during the Second Treatment Period. Participants in the placebo/active group received treatment with placebo during the First Treatment Period and ofatumumab during the second treatment period.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
FG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
FG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
FG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
FG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
FG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Any Adverse Event
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section. Non-serious AEs were not collected during the Individualized Follow-up Period.
Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.
Posted
Number
participants
First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Adverse Events Module
Frequency Threshold
5
Time Frame
Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
Description
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Total Volume of T2 Lesions at Week 24 and Week 48
The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.
Visit 10 (Week 24) and Visit 17 (Week 48)
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).
Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed for tmax.
Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Clearance of Ofa Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.
Weeks 0-2 and 24-26
The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.
Weeks 0-2 and 24-26
Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.
Weeks 0-2 and 24-26
4 subjects
FG0054 subjects
4 subjects
FG0054 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
4 subjects
FG0044 subjects
FG0054 subjects
COMPLETED
FG0008 subjects
FG00110 subjects
FG0027 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
4 subjects
FG0044 subjects
FG0054 subjects
COMPLETED
FG0008 subjects
FG00110 subjects
FG0026 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Not Recommended - Informed Consent Form
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
BG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
BG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
BG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
BG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
BG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
BG006
Total
Total of all reporting groups
8
BG00111
BG0027
BG0034
BG0044
BG0054
BG00638
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00038.0± 9.0
BG00136.6± 7.0
BG00233.7± 8.4
BG00337.0± 6.5
BG00427.0± 2.2
BG00544.0± 8.1
BG00636.3± 7.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0016
BG0024
BG0033
BG0043
BG0050
BG00622
Male
BG0002
BG0015
BG0023
BG0031
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0008
BG00111
BG0027
BG0034
BG0044
BG0054
BG00638
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG0034
OG0044
OG0054
Title
Denominators
Categories
Weeks 0-24
Title
Measurements
OG0008
OG00110
OG0027
OG0033
OG0042
OG0052
Weeks 24-48
Title
Measurements
OG0004
OG0015
OG0024
OG003
Individualized Follow-up Period
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With the Indicated Critical Adverse Events (CAEs)
A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.
FAS
Posted
Number
participants
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 0-24; Influenza
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Number
participants
Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 0; n=8, 8, 2, 4, 3, 4
Title
Measurements
OG0008
OG0018
OG0022
OG003
Primary
Number of Participants With Abnormal Physical Examination Findings
The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.
FAS
Posted
Number
participants
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 0-24; Venous varices on legs
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00110
OG0027
OG003
Title
Denominators
Categories
Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4
Title
Measurements
OG0000± 0
OG0010± 0
OG0020± 0
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00110
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 7, 3, 4, 4
Title
Measurements
OG0000.06± 0.25
OG001-0.11± 0.33
OG002-0.02± 0.23
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00110
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 7, 3, 4, 4
Title
Measurements
OG000-0.00± 0.03
OG0010.01± 0.03
OG002-0.01± 0.02
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00110
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 7, 3, 4, 4
Title
Measurements
OG0000.1± 0.5
OG001-0.3± 0.7
OG002-0.0± 0.5
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG000-0.6± 2.5
OG001-0.5± 2.5
OG0021.3± 1.2
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
Units per liter
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
millimoles per liter
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0000.6± 2.2
OG001-1.1± 2.6
OG002-0.6± 2.5
OG003
Primary
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
Micromoles per liter (µmol/L)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4
Title
Measurements
OG0000.7± 5.2
OG001-0.0± 4.0
OG0021.2± 2.2
OG003
Primary
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
grams per liter
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00110
OG0027
OG003
Title
Denominators
Categories
Week 24, IGA; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0000.05± 0.16
OG0010.08± 0.16
OG0020.40± 0.40
OG003
Primary
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
millimeters of mercury
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4
Title
Measurements
OG0005.3± 11.2
OG001-2.3± 11.1
OG002-5.4± 9.7
OG003
Primary
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
beats per minute
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 7, 4, 4, 4
Title
Measurements
OG000-0.3± 11.5
OG0011.6± 8.4
OG0020.6± 10.7
OG003
Primary
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
Degrees Celsius
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 10, 7, 4, 4, 4
Title
Measurements
OG000-0.1± 0.5
OG0010.1± 0.2
OG002-0.2± 0.5
OG003
Primary
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
Units per milliliter
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG0017
OG0020
OG003
Title
Denominators
Categories
Week 24; n=8, 7, 0, 4, 2, 0
Title
Measurements
OG000-0.6± 4.1
OG001-7.1± 12.9
OG0032.8± 9.1
OG004
Secondary
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. "Total T1 enhancing Ls" represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
lesions
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4
Title
Measurements
OG0000.13± 0.35
OG0010± 0
OG0020± 0
OG003
Secondary
Total Volume of T2 Lesions at Week 24 and Week 48
The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00111
OG0027
OG003
Title
Denominators
Categories
Week 24; n=8, 11, 7, 3, 4, 4
Title
Measurements
OG0007898± 8802
OG00110323± 8281
OG00217399± 11641
OG003
Secondary
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Mean
Standard Deviation
milligrams per liter
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Week 0; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG00032.3± 9.65
OG00185.8± 53.7
OG002176± 24.2
OG003
Secondary
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
milligrams per liter
Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Week 0; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG00036.8± 13.1
OG001124± 23.6
OG002346± 24.0
OG003
Secondary
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Millgram hour per liter
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Week 0; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG000153± 19.4
OG001498± 18.6
OG0021528± 20.7
OG003
Secondary
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
The peripheral blood for each participant was collected and analyzed for tmax.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Posted
Median
Full Range
hours
Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Week 0; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG0005.33(4.00 to 8.60)
OG0015.88(4.17 to 7.67)
OG0026.00(5.17 to 9.42)
Secondary
Clearance of Ofa Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Weeks 0-2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG0000.006± 34.2
OG0010.005± 41.0
OG0020.003± 30.8
OG003
Secondary
The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.
FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Weeks 0-2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG0002.48± 20.4
OG0012.61± 42.0
OG0022.19± 21.3
OG003
Secondary
Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.
FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
OG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
OG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
OG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Units
Counts
Participants
OG0008
OG00110
OG0026
OG003
Title
Denominators
Categories
Weeks 0-2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG000246± 16.1
OG001331± 35.2
OG002452± 28.4
OG003
0
8
8
8
EG001
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
2
11
10
11
EG002
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
0
7
7
7
EG003
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1
4
3
4
EG004
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
0
4
4
4
EG005
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
0
4
4
4
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0002 affected8 at risk
EG0013 affected11 at risk
EG0024 affected7 at risk
EG0032 affected4 at risk
EG0040 affected4 at risk
EG0052 affected4 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Pruritus generalized
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected11 at risk
EG0022 affected7 at risk
EG0033 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Laryngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Tonsilitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Tracheobronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0013 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Varicella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 affected8 at risk
EG0014 affected11 at risk
EG0022 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Burning sensation
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Trigeminal neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Neck pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Depressed mood
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Flushing
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Abnormal sensation in eye
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Vision blurred
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
False positive laboratory result
Investigations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Blood bicarbonate decreased
Investigations
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Tooth extraction
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Acute tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Oral herpes
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Rash generalized
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Anemia
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Hypoaesthesia facial
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Tension headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Oropharyngeal pain
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Pharyngeal edema
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Blepharospasm
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Visual impairment
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0021 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Cytokine release syndrome
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0042 affected4 at risk
EG0050 affected4 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
Bartholin's cyst removal
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
Antibiotic prophylaxis
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected11 at risk
EG0020 affected7 at risk
EG0030 affected4 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
D001327
Autoimmune Diseases
D007154
Immune System Diseases
0 subjects
FG0050 subjects
1
BG0054
BG00616
3
OG0044
OG0054
0
OG0040
OG0050
4
OG0044
OG0054
1
OG0040
OG0050
Week 0-24; Bronchospasm
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Week 0-24; Cough
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Week 0-24; Rash pruritic
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Week 24-48; any CAE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Individualized Follow-up Period; any CAE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
4
OG0044
OG0054
4
OG0043
OG0054
Week 24; n=8, 9, 1, 4, 4, 4
Title
Measurements
OG0008
OG0019
OG0021
OG0034
OG0044
OG0054
Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0008
OG00111
OG0027
OG0034
OG0043
OG0051
Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
IFUP, n=8, 11, 7, 4, 4, 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
4
OG0044
OG0054
0
OG0040
OG0050
Week 0-24; Vertebropathy
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Week 0-24; Obesitas
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Week 0-24; Increased hearing loss
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Week 0-24; Post operative scar
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Week 0-24; Anhidrotic eczema
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Week 24-48; Venous varices on legs
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Week 24-48; Vertebropathy
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Week 24-48; Obesitas
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Week 24-48; Acne vulgaris
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Week 24-48; Post operative scar
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
IFUP; Any physical examination finding
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
3
OG0044
OG0054
0
± 0
OG0040± 0
OG0050± 0
Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4
Title
Measurements
OG0000± 0.05
OG001-0.05± 0.13
OG0020.02± 0.15
OG0030± 0
OG004-0.23± 0.21
OG0050.03± 0.05
Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4
Title
Measurements
OG0000.7± 1.6
OG0010.6± 2.4
OG002-0.1± 3.3
OG003-0.3± 1.6
OG0040.7± 5.9
OG0050.4± 0.7
Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.15± 1.03
OG001-0.36± 0.67
OG002-0.19± 0.78
OG003-0.37± 0.31
OG004-0.60± 0.79
OG0050.12± 0.21
Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.20± 0.31
OG001-0.07± 0.23
OG0020.00± 0.20
OG0030.07± 0.06
OG004-0.40± 0.17
OG0050.05± 0.10
Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.4± 0.9
OG0011± 2.2
OG0020± 3.8
OG003-0.1± 1.5
OG004-0.8± 1.7
OG0050.2± 0.7
Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4
Title
Measurements
OG0000.8± 33.3
OG00110.8± 44.0
OG0027.6± 39.7
OG0030.3± 29.5
OG0045.8± 36.2
OG005-4.8± 34.8
Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3
Title
Measurements
OG0000± 0
OG0010± 0
OG0020± 0
OG0030± 0
OG0040± 0
OG0050± 0
Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4
Title
Measurements
OG0000± 0.05
OG001-0.04± 0.16
OG0020.04± 0.09
OG003-0.07± 0.06
OG004-0.20± 0.28
OG0050.03± 0.13
Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.5± 1.1
OG001-0.1± 1.7
OG002-0.3± 1.1
OG003-0.9± 0.6
OG004-3.7± 1.7
OG0050.9± 0.9
Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4
Title
Measurements
OG000-0.11± 0.36
OG001-0.28± 0.47
OG0020.15± 0.36
OG003-0.50± 0.20
OG004-0.65± 0.78
OG005-0.25± 0.45
Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4
Title
Measurements
OG000-0.20± 0.07
OG001-0.01± 0.12
OG0020.02± 0.17
OG0030.03± 0.06
OG004-0.04± 0.28
OG0050.13± 0.25
Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4
Title
Measurements
OG0000.7± 1.2
OG0010.2± 1.8
OG002-0.4± 1.0
OG003-0.4± 0.4
OG004-2.9± 1.3
OG0051.0± 0.7
Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG000-6.5± 17.3
OG001-16.3± 74.2
OG002-10.1± 14.7
OG003-13.7± 20.6
OG004-34.3± 47.3
OG005-11.0± 38.4
Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0001.30± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-0.60± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0001.90± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-20.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
3
OG0044
OG0054
-0.09
± 0.20
OG004-0.06± 0.42
OG0050.07± 0.12
Week 48; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.05± 0.26
OG0010.12± 0.34
OG0020.12± 0.25
OG0030.01± 0.43
OG0040.06± 0.18
OG0050.09± 0.04
Week 104; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-0.08± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
3
OG0044
OG0054
-0.02
± 0.02
OG0040.02± 0.04
OG0050.01± 0.01
Week 48; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.01± 0.02
OG0010.02± 0.03
OG0020.00± 0.03
OG0030.01± 0.05
OG0040.01± 0.01
OG0050.02± 0.01
Week 104; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000.01± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
3
OG0044
OG0054
-0.4
± 0.4
OG004-0.1± 0.8
OG0050.2± 0.2
Week 48; n=8, 10, 7, 3, 3, 4
Title
Measurements
OG0000.1± 0.5
OG0010.1± 0.7
OG0020.2± 0.5
OG003-0.3± 1.1
OG0040.0± 0.3
OG0050.5± 0.3
Week 104; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000.10± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
-1.6
± 3.4
OG004-1.2± 6.1
OG0052.0± 2.4
Week 48; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0000.1± 2.5
OG001-0.2± 3.1
OG0021.4± 3.0
OG003-1.1± 5.7
OG0040.4± 4.0
OG0051.1± 1.5
Week 104; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-2.00± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
OG00016.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, AST; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0002.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, ALT; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0002.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
1.5
± 3.2
OG004-2.0± 1.3
OG005-0.6± 4.0
Week 24, Glucose; n=8, 10, 7, 4, 4, 4
Title
Measurements
OG000-0.12± 0.59
OG0010.39± 1.37
OG0020.64± 1.23
OG0030.21± 0.42
OG0040.08± 0.63
OG005-0.22± 0.50
Week 24, Potassium; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG000-0.07± 0.35
OG0010.06± 0.52
OG0020.03± 0.27
OG003-0.63± 1.01
OG004-0.20± 0.63
OG005-0.00± 0.16
Week 24, Sodium; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0000.4± 2.7
OG001-0.5± 2.8
OG002-1.2± 1.3
OG0030.5± 1.7
OG0040.8± 2.1
OG0050.5± 2.1
Week 24, Urea; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0000.5± 1.6
OG001-0.8± 1.6
OG0020.4± 1.5
OG003-0.6± 0.8
OG004-0.7± 2.1
OG005-0.1± 0.4
Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4
Title
Measurements
OG000-0.0± 2.9
OG001-0.7± 2.8
OG0020.6± 1.3
OG0030.6± 0.2
OG0041.9± 3.1
OG0051.0± 2.3
Week 48, Glucose; n=8, 10, 7, 4, 2, 4
Title
Measurements
OG0000.10± 0.50
OG0010.25± 0.95
OG002-0.05± 0.51
OG0030.09± 0.56
OG004-0.64± 0.44
OG0050.27± 0.79
Week 48, Potassium; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0004.21± 0.11
OG0014.43± 0.44
OG0024.18± 0.34
OG0034.23± 0.32
OG0043.98± 0.10
OG0054.20± 0.32
Week 48, Sodium; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG000-2.3± 1.6
OG001-0.07± 3.1
OG0020.7± 1.0
OG003-0.5± 3.7
OG004-0.7± 1.2
OG0050.8± 1.0
Week 48, Urea; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0000.13± 1.40
OG001-0.05± 1.32
OG002-0.19± 0.68
OG003-0.30± 1.04
OG0041.00± 2.20
OG005-0.17± 0.46
Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-1.00± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, Glucose; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0001.77± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, Potassium; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000.00± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, Sodium; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0001.00± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, Urea; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0001.00± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
0.5
± 4.0
OG004-2.6± 3.5
OG0050.3± 5.3
Week 24, Creatinine; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG0003.2± 11.8
OG001-0.1± 7.6
OG0022.5± 4.7
OG0032.5± 5.7
OG004-2.9± 7.8
OG005-1.2± 4.0
Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4
Title
Measurements
OG0001.5± 4.9
OG001-0.1± 4.8
OG0021.5± 3.5
OG0030.7± 3.4
OG004-2.8± 1.0
OG0050.6± 2.8
Week 48, Creatinine; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0003.0± 8.7
OG001-1.9± 5.3
OG002-0.3± 4.1
OG0033.5± 6.7
OG004-5.0± 6.5
OG0052.0± 12.5
Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-4.70± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, Creatinine; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG00011.5± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
-0.07
± 0.18
OG0040± 0.44
OG0050.49± 0.35
Week 24, IGG; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG000-0.6± 1.0
OG001-0.1± 0.8
OG0021.2± 1.0
OG003-0.5± 1.0
OG004-0.3± 0.9
OG0051.4± 0.9
Week 24, IGM; n=8, 10, 6, 4, 4, 4
Title
Measurements
OG000-0.09± 0.14
OG001-0.13± 0.39
OG002-0.19± 0.09
OG0030.25± 0.25
OG004-0.07± 0.19
OG0050.04± 0.08
Week 48, IGA; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0000.08± 0.24
OG001-0.03± 0.39
OG0020.13± 0.11
OG003-0.00± 0.24
OG0040.05± 0.21
OG0050.29± 0.26
Week 48, IGG; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG000-0.8± 1.2
OG0010.5± 1.6
OG0021.0± 0.7
OG003-0.6± 1.2
OG0040.2± 1.6
OG0051.2± 0.6
Week 48, IGM; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG000-0.17± 0.24
OG001-0.21± 0.22
OG002-0.18± 0.24
OG003-0.24± 0.24
OG004-0.40± 0.17
OG005-0.13± 0.04
Week 104, IGA; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-0.23± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, IGG; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-0.60± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, IGM; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG000-0.07± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
-3.5
± 7.2
OG0044.0± 4.9
OG005-1.8± 2.2
Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4
Title
Measurements
OG00011.0± 19.7
OG001-2.5± 12.3
OG002-3.1± 14.2
OG0031.5± 11.3
OG0041.0± 9.0
OG005-6.5± 9.5
Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0006.6± 4.6
OG0012.1± 12.0
OG0020.1± 7.8
OG0033.0± 4.7
OG0043.3± 5.8
OG0056.0± 5.8
Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG0002.0± 14.5
OG001-2.5± 13.9
OG002-4.9± 8.2
OG003-2.3± 7.4
OG0041.7± 10.4
OG0054.5± 1.0
4
OG0044
OG0054
1.3
± 13.8
OG0042.0± 8.0
OG0053.8± 8.1
Week 48; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG000-0.1± 9.8
OG0010.4± 11.9
OG002-3.0± 10.7
OG003-5.5± 10.0
OG004-0.3± 9.5
OG0058.0± 5.0
4
OG0044
OG0054
-0.1
± 0.4
OG0040.3± 0.5
OG005-0.3± 0.3
Week 48; n=8, 11, 7, 4, 3, 4
Title
Measurements
OG000-0.1± 0.4
OG0010.1± 0.2
OG0020.1± 0.5
OG003-0.1± 0.2
OG0040.2± 0.3
OG0050.1± 0.3
4
OG0042
OG0050
-19.5
± 24.7
Week 48; n=4, 0, 0, 1, 0, 0
Title
Measurements
OG0003.8± 7.8
OG001NA± NAData were not collected for this cohort.
OG003-31.0± 0
OG004NA± NAData were not collected for this cohort.
4
OG0044
OG0054
3.06
± 4.66
OG00423.50± 43.0
OG0052.50± 3.32
Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4
Title
Measurements
OG0000.13± 0.35
OG0010.09± 0.30
OG0020± 0
OG0033.63± 5.02
OG00425.75± 46.23
OG0054.50± 7.14
Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4
Title
Measurements
OG0000.25± 0.71
OG0010.09± 0.30
OG0020± 0
OG0034.00± 6.52
OG00425.00± 46.03
OG0053.00± 4.24
Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4
Title
Measurements
OG0000± 0
OG0010.27± 0.47
OG0020.29± 0.49
OG0031.50± 3.00
OG0045.00± 9.35
OG0050.25± 0.50
Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4
Title
Measurements
OG0000.13± 0.35
OG0010± 0
OG0020.29± 0.76
OG0030± 0
OG0040.33± 0.58
OG0050± 0
Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4
Title
Measurements
OG0000.13± 0.35
OG0010± 0
OG0020.43± 1.13
OG0030± 0
OG0043.00± 5.20
OG0050± 0
Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4
Title
Measurements
OG0000.13± 0.35
OG0010± 0
OG0020.29± 0.76
OG0030± 0
OG0040.33± 0.58
OG0050± 0
Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4
Title
Measurements
OG0000± 0
OG0010± 0
OG0020± 0
OG0030± 0
OG0043.00± 4.36
OG0050± 0
Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
OG0000.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0
Title
Measurements
OG0000.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0
Title
Measurements
OG0000.0± NAOnly one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
OG001NA± NANo participants were analyzed in this treatment arm at this time point.
OG002NA± NANo participants were analyzed in this treatment arm at this time point.
OG003NA± NANo participants were analyzed in this treatment arm at this time point.
OG004NA± NANo participants were analyzed in this treatment arm at this time point.
OG005NA± NANo participants were analyzed in this treatment arm at this time point.
4
OG0044
OG0054
11290
± 11746
OG00412194± 18008
OG00515039± 8984
Week 48; n=8, 10, 7, 4, 3, 4
Title
Measurements
OG0007791± 8878
OG00111304± 8269
OG00217566± 12413
OG00310684± 8903
OG00418164± 23696
OG00515166± 9060
4
OG0044
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG00023.4± 19.9
OG00164.9± 67.1
OG002174± 187
OG003NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 24; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG00328.9± 8.03
OG00443.4± 67.9
OG00572.7± 128
Week 26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG00321.6± 18.5
OG00447.7± 76.9
OG00582.4± 144
4
OG0043
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG00047.7± 14.7
OG001157± 25.9
OG002452± 28.5
OG003NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 24; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG00333.2± 13.7
OG004137± 40.7
OG005312± 24.5
Week 26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG00343.5± 25.2
OG004210± 54.1
OG005416± 24.6
4
OG0043
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG00015559± 34.4
OG00163165± 40.6
OG002225876± 30.4
OG003NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 24; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG003123± 8.6
OG004624± 32.7
OG0051347± 29.1
Week 26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG00312763± 29.3
OG00471041± 54.9
OG005217757± 44.5
4
OG0043
OG0054
OG003
NA
(NA to NA)
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA(NA to NA)Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA(NA to NA)Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 2; n=8, 10, 6, 0, 0, 0
Title
Measurements
OG0004.25(3.42 to 5.58)
OG0014.33(3.52 to 6.13)
OG0023.83(3.67 to 4.50)
OG003NA(NA to NA)Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA(NA to NA)Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA(NA to NA)Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Week 24; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG0034.42(4.08 to 6.00)
OG0046.00(4.17 to 6.92)
OG0056.54(4.13 to 8.17)
Week 26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA(NA to NA)Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG0033.67(3.58 to 6.00)
OG0045.17(4.08 to 5.50)
OG0054.50(3.75 to 5.50)
4
OG0043
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Weeks 24-26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG0030.008± 29.5
OG0040.004± 54.4
OG0050.03± 44.4
4
OG0043
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Weeks 24-26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG0032.74± 6.54
OG0042.20± 68.0
OG0052.15± 20.8
4
OG0043
OG0054
NA
± NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG004NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
OG005NA± NAOfa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
Weeks 24-26; n=0, 0, 0, 4, 3, 4
Title
Measurements
OG000NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG001NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
OG002NA± NAOfa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.