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Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Plain-language guide to NCT00078338: phase 4 randomized trial of Glatiramer Acetate, multiple sclerosis, 764 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00078338
- Phase
- phase 4
- Status
- completed
- Start
- 2004-02-16
- Completion (planned or actual)
- 2006-11-28
- Participants
- 764 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Relapsing-remitting Multiple Sclerosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.
It had two arms (groups): Rebif® (experimental) and Copaxone® (active comparator).
The registry classes the interventions as drug.
Who Took Part
764 actual participants took part.
It was open to people of any sex aged from 18 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Be between 18 and 60 years of age. Have definite relapsing multiple sclerosis. Have had one or more relapses within the prior 12 months. Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive. Be willing and able to comply with the protocol for the duration of the study.
The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: have secondary progressive multiple sclerosis (spms) or primary progressive ms (ppms); prior use of any interferon or glatiramer acetate; prior cytokine or anti-cytokine therapy within 3 months prior to study day 1.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.
The Glatiramer Acetate group and the comparison group ran side by side rather than switching.
Being open-label, the Glatiramer Acetate study did not mask who received what.
It started in 2004-02-16 with completion listed for 2006-11-28.
It ran at 80 sites in United States (41), Russia (11), Argentina (6), United Kingdom (5), Italy (4) and Spain (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Time to First Relapse (time frame: Baseline up to 96 weeks).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 764 people with multiple sclerosis.
With 764 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Glatiramer Acetate compound page, Multiple sclerosis research.
Our Notes on the Compound
Glatiramer Acetate: A mix of synthetic amino-acid chains (Copaxone) used in relapsing multiple sclerosis.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.