Safety and Efficacy Extension Study of Daclizumab High Yi... | NCT00870740 | Trialant
NCT00870740
Sponsor
Biogen
Status
Completed
Last Update Posted
Aug 30, 2016Estimated
Enrollment
517Actual
Phase
Phase 2
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
BIIB019 (Daclizumab High Yield Process)
Placebo
Countries
Czechia
Germany
Hungary
India
Poland
Russia
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00870740
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
205-MS-202
Secondary IDs
ID
Type
Description
Link
EUDRA CT No.: 2008-005559-46
Brief Title
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Official Title
A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
Acronym
SELECTION
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2009
Primary Completion Date
May 2012Actual
Completion Date
Oct 2012Actual
First Submitted Date
Mar 26, 2009
First Submission Date that Met QC Criteria
Mar 26, 2009
First Posted Date
Mar 27, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
May 31, 2016
Results First Submitted that Met QC Criteria
Jul 19, 2016
Results First Posted Date
Aug 30, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 13, 2014
Certification/Extension First Submitted that Passed QC Review
Oct 13, 2014
Certification/Extension First Posted Date
Oct 22, 2014Estimated
Last Update Submitted Date
Jul 19, 2016
Last Update Posted Date
Aug 30, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
Collaborators
Name
Class
AbbVie
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.
The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.
Detailed Description
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.
Conditions Module
Conditions
Relapsing-Remitting Multiple Sclerosis
Keywords
MS
Multiple Sclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
517Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: DAC HYP 150 mg
Experimental
Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Group 1: DAC HYP 300 mg
Experimental
Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Group 2: Washout then DAC HYP 150 mg
Experimental
Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Placebo
Group 2: DAC HYP 150 mg
Experimental
Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Group 3: Washout then DAC HYP 300 mg
Experimental
Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIIB019 (Daclizumab High Yield Process)
Biological
SC injection
Group 1: DAC HYP 150 mg
Group 1: DAC HYP 300 mg
Group 2: DAC HYP 150 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (AEs)
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Up to 72 weeks
Number of Participants With Abnormalities in Vital Signs
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Up to Week 72
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Up to 72 Weeks
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Secondary Outcomes
Measure
Description
Time Frame
Adjusted Annualized Relapse Rate
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
Key Exclusion Criteria:
Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Placebo
Group 3: DAC HYP 300 mg
Experimental
Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Group 2: Washout then DAC HYP 150 mg
Group 3: DAC HYP 300 mg
Group 3: Washout then DAC HYP 300 mg
Daclizumab HYP
DAC HYP
Placebo
Drug
Placebo SC injection
Group 2: Washout then DAC HYP 150 mg
Group 3: Washout then DAC HYP 300 mg
Up to 72 Weeks
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Up to 72 weeks
Up to 72 weeks
Estimated Proportion of Participants With a Relapse
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.
Up to 72 weeks
Mean Number of New Gadolinium-enhancing Lesions
Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Week 20, Week 52
Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Baseline, Week 20, Week 52
Mean Volume of New T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Baseline, Week 20, Week 52
Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Baseline, Week 52
Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.
Baseline, Week 52
Rate of Percentage Change From Baseline in Mean Total Brain Volume
Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.
Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
FG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
FG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
FG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
FG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
FG00086 subjectsnumber randomized and dosed
FG00184 subjectsnumber randomized and dosed
FG00286 subjectsnumber randomized and dosed
FG00386 subjectsnumber randomized and dosed
FG00488 subjectsnumber randomized and dosed
FG00587 subjectsnumber randomized and dosed
COMPLETED
FG00074 subjects
FG00175 subjects
FG00276 subjects
FG00374 subjects
FG00477 subjects
FG00570 subjects
NOT COMPLETED
FG00012 subjects
FG0019 subjects
FG00210 subjects
FG00312 subjects
FG00411 subjects
FG00517 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG0041 subjects
FG0056 subjects
Consent Withdrawn
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0036 subjects
FG004
Investigator Decision
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Subject Non-compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0002 subjects
FG0015 subjects
FG0022 subjects
FG0034 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
BG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
BG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
BG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
BG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
BG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00086
BG00184
BG00286
BG00386
BG00488
BG00587
BG006517
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.2± 9.78
BG00137.8± 7.98
BG00236.8± 8.76
BG003
Age, Customized
Number
participants
Title
Denominators
Categories
18 to 19 years
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00053
BG00154
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-emergent Adverse Events (AEs)
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.
Posted
Number
participants
Up to 72 weeks
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00086
OG00184
OG00286
OG003
Title
Denominators
Categories
Participants with an AE
Title
Measurements
OG00061
OG00157
OG00270
OG003
Primary
Number of Participants With Abnormalities in Vital Signs
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.
Posted
Number
participants
Up to Week 72
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Secondary
Adjusted Annualized Relapse Rate
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Posted
Number
95% Confidence Interval
relapses per person-years
Up to 72 weeks
ID
Title
Description
OG000
Placebo + DAC HYP
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
OG001
DAC HYP + Washout
Secondary
Estimated Proportion of Participants With a Relapse
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Posted
Number
proportion of participants
Up to 72 weeks
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
Secondary
Mean Number of New Gadolinium-enhancing Lesions
Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Posted
Mean
Standard Deviation
lesions
Week 20, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
OG001
DAC HYP + Washout
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
Secondary
Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Posted
Mean
Standard Deviation
lesions
Baseline, Week 20, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
OG001
DAC HYP + Washout
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
Secondary
Mean Volume of New T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.
Posted
Mean
Standard Deviation
mm^3
Baseline, Week 20, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Secondary
Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Posted
Mean
Standard Deviation
percentage change in volume
Baseline, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
Secondary
Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Posted
Mean
Standard Deviation
percentage change in volume
Baseline, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Primary
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.
Posted
Number
participants
Up to 72 Weeks
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
Primary
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.
Posted
Number
participants
Up to 72 Weeks
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Primary
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.
Posted
Number
participants
Up to 72 weeks
ID
Title
Description
OG000
Placebo + DAC HYP
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
OG001
DAC HYP + Washout
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
OG002
DAC HYP for 2 Years
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
Secondary
Rate of Percentage Change From Baseline in Mean Total Brain Volume
Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Posted
Number
95% Confidence Interval
rate of percentage change
Baseline, Week 52
ID
Title
Description
OG000
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
OG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
OG002
DAC HYP 150 mg + Washout
Time Frame
Study Entry Week 0 (Baseline; Week 52 Visit from study 205MS201 [NCT00390221]) through Week 72 ± 5 days or early termination.
Description
Not provided
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
Placebo + DAC HYP 150 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
15
86
43
86
EG001
Placebo + DAC HYP 300 mg
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
11
84
37
84
EG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
18
86
47
86
EG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
15
86
38
86
EG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
14
88
45
88
EG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
11
87
43
87
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG0031 affected86 at risk
EG0040 affected88 at risk
EG0050 affected87 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Influenza like illness
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Chronic hepatitis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0011 affected84 at risk
EG0020 affected86 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Lung infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Mycobacterium abscessus infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Pyelonephritis chronic
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0011 affected84 at risk
EG0020 affected86 at risk
EG003
Demyelination
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0011 affected84 at risk
EG0020 affected86 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Ischaemic neuropathy
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0011 affected84 at risk
EG0020 affected86 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0009 affected86 at risk
EG0017 affected84 at risk
EG00212 affected86 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Mental disorder due to a general medical condition
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0011 affected84 at risk
EG0020 affected86 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Mesangioproliferative glomerulonephritis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Breast inflammation
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Pityriasis rubra pilaris
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0021 affected86 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected86 at risk
EG0010 affected84 at risk
EG0020 affected86 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected86 at risk
EG0014 affected84 at risk
EG0021 affected86 at risk
EG0035 affected86 at risk
EG0042 affected88 at risk
EG0051 affected87 at risk
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected86 at risk
EG0011 affected84 at risk
EG0022 affected86 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected86 at risk
EG0011 affected84 at risk
EG0022 affected86 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00012 affected86 at risk
EG0018 affected84 at risk
EG00211 affected86 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0005 affected86 at risk
EG0011 affected84 at risk
EG0026 affected86 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0005 affected86 at risk
EG0013 affected84 at risk
EG0024 affected86 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected86 at risk
EG0013 affected84 at risk
EG0025 affected86 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0006 affected86 at risk
EG0014 affected84 at risk
EG0027 affected86 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0002 affected86 at risk
EG0012 affected84 at risk
EG0023 affected86 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected86 at risk
EG0017 affected84 at risk
EG0022 affected86 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected86 at risk
EG0014 affected84 at risk
EG0025 affected86 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected86 at risk
EG00113 affected84 at risk
EG00225 affected86 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected86 at risk
EG0015 affected84 at risk
EG0025 affected86 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Biogen Study Medical Director
Biogen
clinicaltrials@biogen.com
ID
Term
D020529
Multiple Sclerosis, Relapsing-Remitting
D009103
Multiple Sclerosis
Ancestor Terms
ID
Term
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000598527
daclizumab HYP
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
6 subjects
FG0055 subjects
0 subjects
FG0050 subjects
0 subjects
FG0051 subjects
1 subjects
FG0050 subjects
3 subjects
FG0055 subjects
36.2
± 9.30
BG00436.2± 9.03
BG00536.0± 7.60
BG00636.9± 8.77
0
BG0030
BG0041
BG0051
BG0062
20 to 29 years
Title
Measurements
BG00019
BG00113
BG00219
BG00325
BG00420
BG00516
BG006112
30 to 39 years
Title
Measurements
BG00026
BG00137
BG00229
BG00328
BG00435
BG00541
BG006196
40 to 49 years
Title
Measurements
BG00029
BG00128
BG00233
BG00327
BG00424
BG00525
BG006166
50 to 55 years
Title
Measurements
BG00011
BG0016
BG0025
BG0036
BG0047
BG0053
BG00638
> 55 years
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
BG0051
BG0063
59
BG00353
BG00459
BG00548
BG006326
Male
BG00033
BG00130
BG00227
BG00333
BG00429
BG00539
BG006191
86
OG00488
OG00587
57
OG00461
OG00562
Participants with a moderate or severe AE
Title
Measurements
OG00037
OG00133
OG00245
OG00341
OG00435
OG00535
Participants with a severe AE
Title
Measurements
OG0001
OG0013
OG0023
OG0032
OG0044
OG0054
Participants with a possibly/definitely related AE
Title
Measurements
OG00018
OG00112
OG00224
OG00313
OG00422
OG00522
Participants with an SAE
Title
Measurements
OG00015
OG00111
OG00218
OG00315
OG00415
OG00511
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Temperature >38C w/≥1C ↑ BL; n=86,84,85,84,88,87
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
OG002
DAC HYP for 2 Years
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG000163
OG001132
OG002129
Title
Denominators
Categories
Title
Measurements
OG0000.179(0.123 to 0.261)
OG0010.302(0.215 to 0.423)
OG0020.165(0.105 to 0.259)
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00084
OG00179
OG00264
OG00365
OG00468
OG00564
Title
Denominators
Categories
Title
Measurements
OG0000.186
OG0010.166
OG0020.249
OG0030.160
OG0040.235
OG0050.111
OG002
DAC HYP for 2 Years
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG000163
OG001132
OG002129
Title
Denominators
Categories
Week 20
Title
Measurements
OG0000.3± 1.01
OG0011.1± 2.34
OG0020.2± 0.51
Week 52
Title
Measurements
OG0000.2± 0.80
OG0010.2± 0.64
OG0020.2± 1.21
OG002
DAC HYP for 2 Years
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG000156
OG001126
OG002128
Title
Denominators
Categories
Baseline
Title
Measurements
OG00046.0± 36.48
OG00141.1± 36.36
OG00239.8± 32.63
Week 20
Title
Measurements
OG0001.1± 2.26
OG0012.6± 6.33
OG0020.5± 1.28
Week 52
Title
Measurements
OG0002.1± 3.68
OG0013.3± 6.95
OG0021.2± 4.33
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00084
OG00179
OG00264
OG00365
OG00468
OG00564
Title
Denominators
Categories
Baseline; n=83, 79, 63, 64, 66, 64
Title
Measurements
OG000232.13± 467.811
OG001228.90± 390.587
OG002126.50± 288.580
OG00394.20± 281.450
OG00452.26± 184.170
OG00544.92± 150.363
Week 20; n=81, 74, 62, 65, 63, 63
Title
Measurements
OG00036.17± 114.019
OG00162.76± 143.280
OG002161.98± 829.086
OG003
Week 52; n=81, 74, 62, 65, 63, 63
Title
Measurements
OG00088.46± 239.741
OG001109.42± 231.734
OG002142.31± 628.500
OG003
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00081
OG00175
OG00262
OG00365
OG00464
OG00563
Title
Denominators
Categories
Title
Measurements
OG000-7.75± 21.952
OG001-8.44± 13.942
OG002-0.78± 22.243
OG003-4.90± 25.935
OG004-5.40± 16.672
OG005-8.98± 11.673
OG002
DAC HYP 150 mg + Washout
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00081
OG00174
OG00262
OG00365
OG00463
OG00563
Title
Denominators
Categories
Title
Measurements
OG000-3.99± 35.543
OG001-7.15± 39.932
OG002-5.51± 49.970
OG003-13.89± 18.089
OG004-6.72± 22.721
OG005-16.59± 17.436
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00085
OG00184
OG00285
OG00385
OG00488
OG00587
Title
Denominators
Categories
White Blood Cell Count <3.0*10^9 cells/L
Title
Measurements
OG0000
OG0013
OG0023
OG0034
OG0043
OG0052
White Blood Cell Count ≥16.0*10^9 cells/L
Title
Measurements
OG0004
OG0012
OG0021
OG003
Lymphocytes <0.8*10^9 cells/L
Title
Measurements
OG0005
OG0014
OG0026
OG003
Lymphocytes <0.5*10^9 cells/L
Title
Measurements
OG0001
OG0010
OG0021
OG003
Lymphocytes >12*10^9 cells/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils ≤1.0*10^9 cells/L
Title
Measurements
OG0000
OG0010
OG0021
OG003
Neutrophils <1.5*10^9 cells/L
Title
Measurements
OG0000
OG0014
OG0022
OG003
Neutrophils ≥12*10^9 cells/L
Title
Measurements
OG0004
OG0013
OG0022
OG003
RBC Count ≤3.3*10^12 cells/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
RBC Count ≥6.8*10^12 cells/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin ≤100 g/L
Title
Measurements
OG0001
OG0015
OG0023
OG003
Platelet Count ≤100*10^9 cells/L
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet Count ≥600*10^9 cells/L
Title
Measurements
OG0000
OG0012
OG0021
OG003
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Units
Counts
Participants
OG00086
OG00184
OG00286
OG00386
OG00488
OG00587
Title
Denominators
Categories
ALT ≤ULN; n=84,81,78,81,83,79
Title
Measurements
OG00065
OG00162
OG00261
OG00362
OG00460
OG00555
ALT >1 to <3 ULN; n=84,81,78,81,83,79
Title
Measurements
OG00018
OG00117
OG00216
OG003
ALT 3 to 5 ULN; n=84,81,78,81,83,79
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALT >5 to 10 ULN; n=84,81,78,81,83,79
Title
Measurements
OG0001
OG0011
OG0021
OG003
ALT >10 to 20 ULN; n=84,81,78,81,83,79
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT >20 ULN; n=84,81,78,81,83,79
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST ≤ULN; n=85,81,81,84,85,84
Title
Measurements
OG00072
OG00166
OG00271
OG003
AST >1 to <3 ULN; n=85,81,81,84,85,84
Title
Measurements
OG00013
OG00114
OG0029
OG003
AST 3 to 5 ULN; n=85,81,81,84,85,84
Title
Measurements
OG0000
OG0011
OG0021
OG003
AST >5 to 10 ULN; n=85,81,81,84,85,84
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST >10 to 20 ULN; n=85,81,81,84,85,84
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST >20 ULN; n=85,81,81,84,85,84
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP ≤ULN; n=84,84,84,84,86,86
Title
Measurements
OG00076
OG00183
OG00280
OG003
ALP >1 to 2.5 ULN; n=84,84,84,84,86,86
Title
Measurements
OG0008
OG0011
OG0024
OG003
ALP >2.5 to 5 ULN; n=84,84,84,84,86,86
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP >5 to 20 ULN; n=84,84,84,84,86,86
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP >20 ULN; n=84,84,84,84,86,86
Title
Measurements
OG0000
OG0010
OG0020
OG003
GGT ≤ULN; n=81,79,81,82,84,82
Title
Measurements
OG00074
OG00171
OG00274
OG003
GGT >1 to 2.5 ULN; n=81,79,81,82,84,82
Title
Measurements
OG0005
OG0018
OG0025
OG003
GGT >2.5 to 5 ULN; n=81,79,81,82,84,82
Title
Measurements
OG0002
OG0010
OG0022
OG003
GGT >5 to 20 ULN; n=81,79,81,82,84,82
Title
Measurements
OG0000
OG0010
OG0020
OG003
GGT >20 ULN; n=81,79,81,82,84,82
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin ≤ULN; n=81,79,83,81,85,80
Title
Measurements
OG00074
OG00173
OG00281
OG003
Total Bilirubin >1 to 1.5 ULN; n=81,79,83,81,85,80
Title
Measurements
OG0005
OG0016
OG0022
OG003
Total Bilirubin >1.5 to 3 ULN; n=81,79,83,81,85,80
Title
Measurements
OG0002
OG0010
OG0020
OG003
Total Bilirubin >3 to 10 ULN; n=81,79,83,81,85,80
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin >10 ULN; n=81,79,83,81,85,80
Title
Measurements
OG0000
OG0010
OG0020
OG003
TSH-3rd Gen Abnormal; n=79,79,74,77,79,79
Title
Measurements
OG0002
OG0011
OG0022
OG003
Free Thyroxine (T4) Abnormal; n=78,80,73,73,80,79
Title
Measurements
OG0004
OG0014
OG0025
OG003
Total Thyroxine (T4) Abnormal; n=76,80,74,72,80,79
Title
Measurements
OG0003
OG00110
OG0026
OG003
Units
Counts
Participants
OG000169
OG001171
OG002170
Title
Denominators
Categories
ADAb Positive
Title
Measurements
OG0007
OG00121
OG0023
ADAb Negative
Title
Measurements
OG000162
OG001150
OG002167
NAb Positive
Title
Measurements
OG0004
OG0014
OG0021
NAb Negative
Title
Measurements
OG000165
OG001167
OG002169
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
OG003
DAC HYP 150 mg for 2 Years
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
OG004
DAC HYP 300 mg + Washout
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
OG005
DAC HYP 300 mg for 2 Years
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.