Phase 3
Completed N=1,516
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT00906399 ↗Enrolled (actual)
1,516
Serious AEs
13.5%
Results posted
Sep 2014
Primary outcomePrimary: Annualized Relapse Rate (ARR) at 1 Year — 0.397; 0.288; 0.256 relapses per person-years — p=0.0114
Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) at 1 Year |
0.397; 0.288; 0.256 | 0.0114 sig |
| SECONDARY Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year |
10.9; 7.9; 3.6 | 0.0008 sig |
| SECONDARY Proportion of Participants Relapsed at 1 Year |
0.291; 0.222; 0.187 | 0.0200 sig |
| SECONDARY Estimated Proportion of Participants With Sustained Disability Progression at 1 Year |
0.105; 0.068; 0.068 | 0.0380 sig |
Eligibility Criteria
Key Inclusion Criteria
- Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
- Must have an EDSS score between 0.0 and 5.0.
- Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Key Exclusion Criteria
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
- Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00906399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.