Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00078338|
Recruitment Status : Completed
First Posted : February 26, 2004
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-remitting Multiple Sclerosis||Drug: Rebif® Drug: Copaxone®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||764 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis|
|Actual Study Start Date :||February 16, 2004|
|Actual Primary Completion Date :||November 28, 2006|
|Actual Study Completion Date :||November 28, 2006|
Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
Other Name: Recombinant interferon beta-1a
|Active Comparator: Copaxone®||
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Other Name: Glatiramer acetate
- Time to First Relapse [ Time Frame: Baseline up to 96 weeks ]Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078338
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|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|