CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,516 enrolled
Drug / intervention
BIIB017 (peginterferon beta-1a) +1 moredrug
Likely dose
BIIB017 (peginterferon beta-1a) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00906399
NCT00906399Phase 3Completed
CompareCT.gov

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

Biogen·interventional·Posted May 21, 2009·Updated Sep 19, 2014

In Brief

A Phase 3 clinical trial evaluating BIIB017 (peginterferon beta-1a) and Placebo for Relapsing Multiple Sclerosis. Completed, enrolled 1,516 participants across 178 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesBelgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.1 years ago

Interventions

BIIB017 (peginterferon beta-1a)drug

Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.

Placebodrug

Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.