BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046)
Intervention description: 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).; 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).; 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).
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1420.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the BEYOND study 306440 as scheduled

          -  Relapsing multiple sclerosis

          -  Medical assessment by the investigator that there is no objection to the patient's
             participation in this trial considering the medical experience from study 306440.
             Special attention should be given to laboratory abnormalities and clinically relevant
             liver, renal and bone-marrow dysfunction.

          -  Females of child-bearing potential:

               -  Agreement to practice adequate contraception methods and

               -  Negative pregnancy test and

               -  No lactation

          -  Written informed consent

        Exclusion Criteria:

          -  Serious or acute heart diseases

          -  History of severe depression or suicide attempt

          -  Epilepsy not adequately controlled by treatment

          -  Known allergy to IFNs, to human albumin or to mannitol

          -  Medical, psychiatric or other conditions that compromise the patient's ability to
             understand the patient information, to give informed consent, to comply with the trial
             protocol, or to complete the study