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Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: BIIB017 (peginterferon beta-1a) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Annualized Relapse Rate (ARR) at 1 Year

Secondary outcome:

Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year

Proportion of Participants Relapsed at 1 Year

Estimated Proportion of Participants With Sustained Disability Progression at 1 Year

Detailed description: This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, 'Sint-Truiden 3800, Belgium

Research Site, Bruxelles 1200, Belgium

Research Site, Plovdiv 4002, Bulgaria

Research Site, Sofia 1113, Bulgaria

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Research Site, Osijek 31000, Croatia

Research Site, Zagreb 10000, Croatia

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Research Site, Amiens 80054, France

Research Site, Clermont-Ferrand 63003, France

Research Site, Lyon 69394, France

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Additional Information

Starting date: June 2009
Last updated: September 15, 2014

Page last updated: August 23, 2015

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