Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.
Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer
306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned
study medication, applying the same level of blinding as during the BEYOND study, All
patients randomized during the BEYOND study to Copaxone and all patients with premature
discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b
250µg.
Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)
Randomization: No randomization in this trial, patient's allocation in this follow-up study
depends only on prior trial groups. The preceding study was randomized.
The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer
HealthCare Pharmaceuticals Inc.
Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The
variables FAMS and EQ-5D were not analyzed due to the termination of the study before start
of Phase B.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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