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

NCT00906399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1516

Last updated 2014-09-19

Study results available
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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.

Conditions

Interventions

DRUG

BIIB017 (peginterferon beta-1a)

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.

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-10-31
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • 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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906399 on ClinicalTrials.gov