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BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Plain-language guide to NCT00099502: phase 3 randomized trial of Glatiramer Acetate, multiple sclerosis, 2244 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00099502
- Phase
- phase 3
- Status
- completed
- Start
- 2003-11
- Completion (planned or actual)
- 2007-08
- Participants
- 2244 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Multiple Sclerosis, Relapsing-Remitting
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Glatiramer Acetate for multiple sclerosis.
It had three arms (groups): Arm 1 (experimental), Arm 2 (experimental) and Arm 3 (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 2244 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Female and male patients. Aged 18-55 years. Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0. Treatment-naive to IFNB or Copaxone.
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: neurological progression at disease onset or between relapses; serious or acute heart diseases; history of severe depression or suicide attempt.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
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.
Blinding on both sides kept the multiple sclerosis participants and researchers unaware of who received Glatiramer Acetate.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2003-11 with completion listed for 2007-08.
It ran at 199 sites in United States (57), Germany (22), Canada (13), France (12), Russia (11) and Brazil (8).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example Time to confirmed Expanded Disability Status Score (EDSS) progression and Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 2244 people with multiple sclerosis.
With 2244 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.