At a glance
ClinicalIndex Comparison Record- ✓Age 18-60 years
- ✓Definite relapsing-remitting multiple sclerosis diagnosis
- ✓At least one relapse in prior 12 months
- ✓Clinically stable or improving neurological state for 4 weeks prior to study start
- ✕Secondary progressive MS or primary progressive MS
- ✕Prior use of interferon or glatiramer acetate
- ✕Systemic corticosteroids or ACTH within 4 weeks of study start or within 7 days of baseline MRI
- ✕Prior immunomodulatory or immunosuppressive therapy (cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Rebif® and Copaxone® for Relapsing-remitting Multiple Sclerosis. Completed, enrolled 764 participants across 80 sites in 12 countries.
Detailed Summary
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
Study Details
Timeline
Interventions
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).
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).