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NCT00906399 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
Phase 3
Development phase
1,516
Enrollment target
20
Study locations

NCT00906399 is a Phase 3 study of Relapsing Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 1,516 participants, below the 2,103-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00906399, a Phase 3 study of Relapsing Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 3
Development phase
1,516 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG Placebo
  • DRUG BIIB017 (peginterferon beta-1a)

Study Locations (20)

Other

  • Research Site - Brussels
  • Research Site - Sint-Truiden
  • Research Site - Plovdiv
  • Research Site - Sofia
  • Research Site - Sofia
  • Research Site - Sofia
  • Research Site - Sofia
  • Research Site - Sofia

Ohio

  • Research Site - Akron
  • Research Site - Cleveland

Arizona

  • Research Site - Phoenix

Florida

  • Research Site - Ponte Vedra Beach

Georgia

  • Research Site - Atlanta

Iowa

  • Research Site - Des Moines

Kentucky

  • Research Site - Lexington

Maryland

  • Research Site - Baltimore

Trial Details

FieldValue
Enrollment Target 1,516 participants
Start Date 2009-06
Est. Completion 2013-10
Phase Phase 3

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT00906399

The ClinicalTrials.gov registry entry for NCT00906399 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,516 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,103-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (28% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00906399 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Ohio, Arizona.

Frequently Asked Questions

What is clinical trial NCT00906399 about?

NCT00906399 is a clinical study titled "Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis". 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 ...

What is the current status of trial NCT00906399?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,516 participants. The study started on 2009-06. Estimated completion is 2013-10.

What conditions does trial NCT00906399 study?

This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.

What interventions are being tested in trial NCT00906399?

The interventions under investigation include: Placebo (DRUG), BIIB017 (peginterferon beta-1a) (DRUG).

Who is sponsoring clinical trial NCT00906399?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00906399 being conducted?

This trial has 20 study locations across Arizona, Florida, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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