A Study of the Pharmacokinetics and Safety of MK-8808 (MK... | NCT01390441 | Trialant
NCT01390441
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Jul 20, 2016Estimated
Enrollment
100Actual
Phase
Phase 1
Conditions
Rheumatoid Arthritis
Interventions
MK-8808
MabThera® (rituximab)
Methotrexate
Rituxan® (rituximab)
Methylprednisolone
Acetaminophen
Loratadine
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01390441
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8808-002
Secondary IDs
Not provided
Brief Title
A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)
Official Title
A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2016
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early by the Sponsor for business reasons.
Expanded Access Info
No
Start Date
Jul 2011
Primary Completion Date
Apr 2014Actual
Completion Date
Apr 2014Actual
First Submitted Date
Jul 7, 2011
First Submission Date that Met QC Criteria
Jul 7, 2011
First Posted Date
Jul 11, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2016
Results First Submitted that Met QC Criteria
Jun 8, 2016
Results First Posted Date
Jul 20, 2016Estimated
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
Jun 8, 2016
Last Update Posted Date
Jul 20, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808 versus rituximab (MabThera® and Rituxan®) in participants with moderate to severe RA with an inadequate response or intolerance to methotrexate.
Detailed Description
In Part A of the base study, participants are randomized to either MK-8808 or MabThera®. In Part B of the base study, participants are randomized to either MK-8808, MabThera®, or Rituxan®. Participants enrolled in Part A are not eligible to participate in Part B. In both Parts A and B, participants will receive one or two courses of therapy, with each course including two infusions of the study drugs.
The extension portion of the study (Part C) will sequentially follow the base study beginning at Week 52 and continue for an additional 54 weeks. All participants who meet eligibility criteria and continue into the study extension will be treated with open-label MK-8808. Participants randomized to MK-8808 in the base study will remain on the same therapy. Participants randomized to rituximab (MabThera® or Rituxan®) in the base study will be switched to MK-8808 for the extension study.
During the Treatment Period, participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (with a second optional course of treatment at Weeks 26 and 28). Participants are followed up to Week 52 in the Treatment Period.
During the Extension Period, participants receive open-label MK-8808 (1000 mg) administered IV at Week 54 and Week 56 (with a second optional course at Weeks 80 and 82). Participants are followed up to Week 106 in the Extension Period.
Methotrexate 12.5 to 25 mg/week is administered either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial. A 10 mg dose may be administered if a greater dose is not tolerated.
During the Treatment Period, participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (with a second optional course of treatment at Weeks 26 and 28). Participants are followed up to Week 52 in the Treatment Period.
During the Extension Period, participants receive open label MK-8808 (1000 mg) administered IV at Week 54 and Week 56 (with a second optional course at Weeks 80 and 82). Participants are followed up to Week 106 in the Extension Period.
Methotrexate 12.5 to 25 mg/week is administered either orally, SC, or IM for the duration of the trial. A 10 mg dose may be administered if a greater dose is not tolerated.
Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.
Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85
Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.
Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
Number of Participants Who Discontinued Study Drug Due to Adverse Events
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks
Secondary Outcomes
Measure
Description
Time Frame
Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.
Day 15
Other Outcomes
Measure
Description
Time Frame
Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Female participants of reproductive potential must demonstrate a serum β-human chorionic gonadotropin (hCG) level consistent with the nongravid state at the pre-study (screening) visit, and a negative urine pregnancy test within 24 hours prior to all doses and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug, throughout the study (including washout intervals between treatment periods/panels) and until at least 12 months after administration of the last dose of study drug in the last treatment period
The participant has a Body Mass Index (BMI) ≤35 kg/m^2 at the prestudy (screening) visit
For Part A Only: The participant has a body surface are (BSA) ≤2.0 m^2 at the prestudy (screening) visit.
Has satisfied at least 4 of 7 American Rheumatology Association (ARA) 1987 revised criteria for the diagnosis of RA
Is American College of Rheumatology (ACR) Functional Class I, II, or III
Had a diagnosis of RA made at least 6 months prior to the prestudy (screening) visit, was ≥ 16 years of age when diagnosed, and has active disease
Is on a stable oral, IM, or SC dose of methotrexate and is continuing to take methotrexate
Has an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD)
For Part A: Participant is either naïve to biological therapy for RA or has had an inadequate response to previous or current treatment with an anti-tumor necrosis factor (TNF) treatment (patient could have failed up to three anti-TNF agents treatments) or participant has had intolerance up to three anti-TNF treatments.
For Part B: Participant has had an inadequate response to previous or current treatment with an anti-TNF treatment (patient could have failed up to three anti-TNF agents treatments) or participant has had intolerance up to three anti-TNF treatments
Participant has no clinically significant abnormality on electrocardiogram performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
For Part B Only: Participant is positive for rheumatoid factor (RF) or, if negative for RF, is positive for anti-CCP at screening visit
For Part C Only: Participant must have completed the first 52 weeks of treatment in the base study
For Part C Only: Participant achieved a minimum 20% response from baseline on the American College of Rheumatology (ACR) Responder Index (ACR20) at Visit 19 (last visit for the base study)
Exclusion Criteria:
Mentally or legally incapacitated, has significant emotional problems at the time of the prestudy (screening) visit or during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years
Creatinine clearance of ≤ 80 mL/min
History of stroke, chronic seizures or major neurological disorder
History of neoplastic disease, except treated basal cell carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥ 5 years
History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disease regardless of the time since treatment
History of coronary artery disease, congestive heart failure (New York Heart Association Class I-IV), or a history of clinically significant arrhythmia (including any history of atrial fibrillation, atrial flutter, or any sustained ventricular arrhythmia)
Hypersensitivity or allergy to rituximab or any of the excipients of MK-8808 or rituximab (MabThera® or Rituxan® )
History of a rheumatic autoimmune disease other than RA (e.g. systemic lupus erythematosus (SLE), polymyositis, etc.)
Severe active infection of any type or history of a medically serious infection as defined by a history of treatment requiring hospitalization, long term IV outpatient treatment for systemic bacterial, viral or fungal infection, use of IV antibiotics within 30-days of screening, or use of antibiotic therapy three or more times in the last six months prior to screening
History of opportunistic infection
Active-virus vaccination within 4 weeks
Active tuberculosis with or without adequate treatment, history of latent tuberculosis without written confirmation from health care provider of adequate prophylaxis or any evidence of tuberculosis on a chest X-ray performed within 3 months of dosing
Chronic hepatitis B or hepatitis C infection or has human immunodeficiency virus (HIV) infection
Previously treated with rituximab (MabThera® or Rituxan®) or any investigational anti-CD20 antibody
Active use or planned use of a prohibited DMARD during the course of study participation, and/or insufficient washout from a prohibited DMARD at the time of the planned first dose of MK-8808/rituximab (MabThera® or Rituxan®)
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks
Participated in another investigational study with length of time within at least 5 half-lives of the previous investigational study drug
Pregnant or breastfeeding or expecting to conceive
Allergy to murine proteins
Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
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.
For Part B only, positive for rheumatoid factor (RF) or, if negative for RF, positive for anti-cyclic citrullinated protein antibodies at the screening visit.
Recruitment Details
The study enrolled participants 18 to 65 years of age with a diagnosis of moderate/severe rheumatoid arthritis (RA), naive to treatment or having failed >=1 anti-TNF agent, and on a stable dose of methotrexate. Not all participants completing the Treatment Period entered the Extension Period due to study early termination.
Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period
Type
Comment
Milestone Data
STARTED
FG00023 subjects
FG00122 subjects
FG00218 subjects
FG00319 subjects
FG00418 subjects
COMPLETED
FG00022 subjects
FG00121 subjects
FG0028 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG00210 subjects
FG00313 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Extension Period
Type
Comment
Milestone Data
STARTED
FG00015 subjectsNot all participants entered the Extension Period due to early termination of the study.
FG00113 subjectsNot all participants entered the Extension Period due to early termination of the study.
FG0021 subjectsNot all participants entered the Extension Period due to early termination of the study.
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
BG001
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
Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.
Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course
Posted
Geometric Mean
95% Confidence Interval
hr*mg/mL
Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Adverse Events Module
Frequency Threshold
5
Time Frame
Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
Description
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
In the Treatment Period, participants receive one course of MK-8808 (1000 mg) administered IV on Day 1 and Day 15 (with a second optional course of treatment at Weeks 26 and 28). Participants are followed up to Week 52 in the Treatment Period.
In the Extension Period, participants receive open label MK-8808 (1000 mg) adminstered IV at Week 54 and Week 56 (with a second optional course at Weeks 80 and 82). Participants are followed up to Week 106 in the Extension Period.
Methotrexate 12.5 to 25 mg/week is administered either orally, SC, or IM for the duration of the trial. A 10 mg dose may be administered if a greater dose is not tolerated.
In the Treatment Period, participants receive one course of MabThera® (1000 mg) administered IV on Day 1 and Day 15 (with a second optional course of treatment at Weeks 26 and 28). Participants are followed up to Week 52 in the Treatment Period.
In the Extension Period, participants receive open label MK-8808 (1000 mg) administered IV at Week 54 and Week 56 (with a second optional course at Weeks 80 and 82). Participants are followed up to Week 106 in the Extension Period.
Methotrexate 12.5 to 25 mg/week is administered either orally, SC, or IM for the duration of the trial. A 10 mg dose may be administered if a greater dose is not tolerated.
In the Treatment Period, participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (with a second optional course of treatment at Weeks 26 and 28). Participants are followed up to Week 52 in the Treatment Period.
In the Extension Period, participants receive open label MK-8808 (1000 mg) administered IV at Week 54 and Week 56 (with a second optional course at Weeks 80 and 82). Participants are followed up to Week 106 in the Extension Period.
Methotrexate 12.5 to 25 mg/week is administered either orally, SC, or IM for the duration of the trial. A 10 mg dose may be administered if a greater dose is not tolerated.
Methylprednisolone 100 mg administered IV before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions
Acetaminophen 1000 to 1350 mg administered orally before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions
Part B: Cmax After the Second Infusion of a Single Course of Treatment
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.
Day 15
Week 24
Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
Week 24
Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.
Baseline, Week 6, Week 12
7 subjects
11 subjects
0 subjects
FG0040 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Unknown due to early stopping of study
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG00311 subjects
FG0047 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
1 subjects
Not all participants entered the Extension Period due to early termination of the study.
FG0043 subjectsNot all participants entered the Extension Period due to early termination of the study.
COMPLETED
FG00012 subjects
FG00112 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Type
Comment
Reasons
Protocol Violation
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
BG002
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
BG003
Part B: MabThera® 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
BG004
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
BG005
Total
Total of all reporting groups
23
BG00122
BG00218
BG00319
BG00418
BG005100
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00051.7± 6.7
BG00151.5± 8.4
BG00246.4± 10.9
BG00348.7± 12.4
BG00446.2± 10.5
BG00549.1± 9.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00119
BG00214
BG00316
BG00415
BG00584
Male
BG0003
BG0013
BG0024
BG0033
BG004
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00022
OG00119
Title
Denominators
Categories
Title
Measurements
OG000110.56(94.51 to 129.32)
OG001110.12(91.97 to 131.84)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.
ANOVA
Geometric mean ratio
1.00
2-Sided
90
0.87
1.16
Yes
Non-Inferiority or Equivalence
PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.
Primary
Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.
PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.
Posted
Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85
ID
Title
Description
OG000
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part B: MabThera® 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG0000
OG0010
OG0020
Primary
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.
Posted
Number
Participants
Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part A: MabThera 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG003
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG004
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG005
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG006
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG007
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG008
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG009
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00023
OG00122
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG00018
OG00121
OG00212
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m^2 - Part A: MabThera 500 mg/m^2) when >=4 participants in an arm experienced an event.
Miettinen-Nurminen
Percent difference
-17.2
2-Sided
95
-38.6
3.6
No
Superiority or Other
OG002
OG003
Primary
Number of Participants Who Discontinued Study Drug Due to Adverse Events
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
APaT population defined as all participants who received at least one dose of study drug.
Posted
Number
Participants
Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG003
Part B: MabThera® 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG004
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG005
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG007
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG008
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG009
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00023
OG00122
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0021
OG003
Secondary
Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.
Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Day 15
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00022
OG00119
Title
Denominators
Categories
Title
Measurements
OG000326.49(287.72 to 370.49)
OG001332.39(287.48 to 384.31)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.
ANOVA
Geometric mean ratio
0.98
2-Sided
90
0.87
1.1
Yes
Non-Inferiority or Equivalence
PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.
Secondary
Part B: Cmax After the Second Infusion of a Single Course of Treatment
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.
PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.
Posted
Day 15
ID
Title
Description
OG000
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part B: MabThera® 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG0000
OG0010
OG0020
Other Pre-specified
Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
Posted
Number
Participants
Week 24
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
OG001
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00023
OG00121
Title
Denominators
Categories
ACR20
Title
Measurements
OG00023
OG00120
ACR50
Title
Measurements
OG000
Other Pre-specified
Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
Posted
Number
Participants
Week 24
ID
Title
Description
OG000
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG001
Part B: MabThera® 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00017
OG00118
OG00217
Title
Denominators
Categories
ACR20
Title
Measurements
OG00016
OG00117
OG00215
ACR50
Other Pre-specified
Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.
FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
Posted
Mean
Standard Deviation
Score
Baseline, Week 6, Week 12
ID
Title
Description
OG000
Part A: MK-8808 500 mg/m^2
Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
OG001
Part A: MabThera® 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG00023
OG00121
Title
Denominators
Categories
Week 6 (n=22, n=20)
Title
Measurements
OG000-1.39± 1.02
OG001-1.16± 1.26
Week 12 (n=21, n=21)
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Estimated difference vs MabThera® at 6 weeks.
ANCOVA
The model included a term for treatment.
Mean Difference (Final Values)
-0.2
2-Sided
95
-0.9
0.5
Yes
Non-Inferiority or Equivalence
OG000
OG001
Primary
Number of Participants With Immunoglobulin G (IgG) Response in the Extension Study
Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.
The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.
Posted
Week 54, Week 68, Week 80, Week 94, Week 106
ID
Title
Description
OG000
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG003
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG004
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants Positive for Anti-Drug Antibody (ADA) Formation in the Extension Study
Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.
The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.
Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG002
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG003
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
OG004
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
1
23
15
23
EG001
Part A: MabThera 500 mg/m^2
Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
1
22
17
22
EG002
Part B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
2
18
11
18
EG003
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
19
16
19
EG004
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
18
13
18
EG005
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
13
2
13
EG007
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
1
0
1
EG008
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
1
0
1
EG009
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
0
3
0
3
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
EG0001 events1 affected23 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Anisocytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Hypercoagulation
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Microcytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Polychromasia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected18 at risk
EG0032 events1 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Supraventricular extrasystoles
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Ear pruritus
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Vision blurred
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Duodenal ulcer
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Gastritis erosive
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Infusion site erythema
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Anaphylactic reaction
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Hypersensitivity
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0033 events2 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Bacteriuria
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0022 events2 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Hepatitis C
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Herpes zoster
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0013 events3 affected22 at risk
EG0022 events2 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Laryngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Pharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Rhinitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Tooth infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0042 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0033 events2 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0015 events2 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Viral infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Burns second degree
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Blood creatinine increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Blood pressure decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0022 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Haemoglobin decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Hepatitis B surface antigen positive
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 affected1 at risk
EG0090 events0 affected3 at risk
Lymphocyte count decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
QRS axis abnormal
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Red blood cell elliptocytes present
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Red blood cells urine positive
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
White blood cells urine positive
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0032 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0012 events2 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Paraesthesia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0022 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Renal amyloidosis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0013 events3 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events1 affected22 at risk
EG0022 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0013 events2 affected22 at risk
EG0021 events1 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0062 events1 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 events3 affected23 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected18 at risk
EG0036 events4 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Macule
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected18 at risk
EG0031 events1 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Flushing
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
Venous thrombosis limb
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected3 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D011239
Prednisolone
D011246
Pregnadienetriols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D000083
Acetanilides
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Aniline Compounds
D000588
Amines
D003533
Cyproheptadine
D003986
Dibenzocycloheptenes
D001567
Benzocycloheptenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D010880
Piperidines
D006573
Heterocyclic Compounds, 1-Ring
3
BG00516
19
OG00418
OG00515
OG00613
OG0071
OG0081
OG0093
16
OG00413
OG0052
OG0062
OG0070
OG0080
OG0090
The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when >=4 participants in an arm experienced an event.
Miettinen-Nurminen
Percent difference
-17.5
2-Sided
95
-44.4
10.9
No
Superiority or Other
OG002
OG004
The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when >=4 participants in an arm experienced an event.
Miettinen-Nurminen
Percent difference
-5.6
2-Sided
95
-34.9
24.6
No
Superiority or Other
OG003
OG004
The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when >=4 participants in an arm experienced an event.