Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1420
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind) arm 2: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind) arm 3: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day

\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Interventions: intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046) intervention 3: Interferon beta-1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). intervention 2: Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). intervention 3: Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).

Protocol document: