CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,008 enrolled
Drug / intervention
Interferon beta 1-a +2 moredrug
Likely dose
Interferon beta-1a intramuscular and/or glatiramer acetate subcutaneousAI-extracted
Key inclusion· 4
  • ✓Age 18–60 years
  • ✓Diagnosis of relapsing-remitting MS (Poser or McDonald criteria)
  • ✓EDSS score 0–5.5
  • ✓At least 2 exacerbations in prior 3 years (one may be MRI-defined by McDonald criteria)
Key exclusion· 10
  • ✕Any prior use of interferon beta or glatiramer acetate
  • ✕Acute exacerbation within 30 days of screening
  • ✕High-dose steroids (>100 mg/day) within 30 days or chronic systemic steroid use
  • ✕Evidence of progressive MS

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

Search/NCT00211887
NCT00211887Phase 3Completed
CompareCT.gov

A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)

Fred Lublin·interventional·Posted Sep 21, 2005·Updated Apr 3, 2014

In Brief

A Phase 3 clinical trial evaluating Interferon beta 1-a, glatiramer acetate, and 1 other intervention for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 1,008 participants across 71 sites in 2 countries.

Detailed Summary

This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesCanada, United States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartJan 1, 2005
Primary CompletionApr 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.8 years ago

Interventions

Interferon beta 1-adrug

The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).

glatiramer acetatedrug

The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).

placeboother

an inactive substance