Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with relapses MedDRA version: 7.1 Level: LLT Classification code 10028245
Conditions
Interventions
Trade Name: Rebif
Product Name: Rebif 8,8 µg, Rebif 22µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1 a
Concentration unit: µg microgram(s)
Concentration type: eq
Sponsors
Serono GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Definite RRMS or SPMS with relapses - EDSS 1-6 - Escalation to mitoxantrone due to relapse activity or MRI activity during last year prior to mitoxantrone or EDSS progression combined with relapse activity or MRI activity during last year prior to mitoxantrone (not due to EDSS progression exclusively) - Last mitoxantrone treatment between >= 1 and 5.5) within the last 9 months - Subject should be free of relapses over the last 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject received any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1 (SD1, week 0) - Subject was escalated to mitoxantrone due to EDSS progression only (without any relapse or MRI activity during the last year prior to mitoxantrone - Subject has Primary Progressive MS - Subject has Secondary Progressive MS without superimposed relapses - Subject received immunmodulatory treatment other than IFN-beta, glatirameracetat, azatriopine, immunglobulins, or no treatment before mitoxantrone - Subject has previously received total lymphoid irradiation - Subject received oral or systemic corticosteroids or ACTH within 30 days of SD1 - Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1 - Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, teriflunomide, laquinimod, Campath) within the 12 months prior to SD1 - Subject requires chronic or monthly pulse corticosteroids during the study - Subject received any investigational drug or experimental procedure within 12 month of SD1 (Week 0) or is currently participating in another clinical trial - Subject suffers from major medical or psychiatric illness (e.g. severe depression and/or suicide risk) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol - Known clinically significant cardiac or other systemic diseases - Previous treatment with natalizumab - Subject suffers from epilepsy without adeqaute therapeutic control of attacks - Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 times the lower limit of normal and platelet count <100x103/µl. - Subject suffers from the following concurrent autoimmune diseases: SLE, ITP, Rheumatoid arthritis, Crohn´s Disease, Diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to asses if treatment with Rebif 44 mcg three times per week compared with subjects not treated during 96 weeks can maintain or prolong clinical or MRI stability after previous treatment with mitoxantrone.;Secondary Objective: The main secondary objective of the study is to compare the mean number of T2 active lesions, defined as new or enlarging T2 lesions, per subject per scan during 96 weeks of treatment with Rebif 44 mcg three times per week with subjects not treated.;Primary end point(s): The primary outcome measure will be time to first relapse on study in subjects treated with Rebif 44 mcg three times per week compared with subjects not treated over 96 weeks. | — |
Countries
Germany
Outcome results
None listed