A TWO-ARM, RANDOMISED, DOUBLE-BLIND, CONTROL GROUP-COMPARED, MULTICENTRE, PHASE IIIB STUDY WITH MONTHLY MRI AND BIOMARKER ASSESSMENT TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF REBIF NEW FORMULATION (IFN-BETA-1A) IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS - IMPROVE (INVESTIGATING MRI PARAMETERS WITH REBIF IMPROVED FORMULATION)
- Conditions
- RELAPSING REMITTING MULTIPLE SCLEROSISMedDRA version: 6.1Level: PTClassification code 10028245
- Registration Number
- EUCTR2006-003037-32-IT
- Lead Sponsor
- MERCK SERONO INTERNATIONAL SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
- MALES AND FEMALES BETWEEN 18 AND 60 YEARS OF AGE
- HAVE RRMS ACCORDING TO THE REVISED MCDONALD CRITERIA (2005)
- HAVE BRAIN AND/OR SPINAL MRI WITH FINDINGS TYPICAL OF MS
- HAVE DISEASE DURATION FOR >12 MONTHS
- HAVE DISEASE ACTIVITY CHARACTERIZED BY AT LEAST ONE CLINICAL EVENT AND ONE OR MORE GD-ENHANCING MRI LESIONS DURING THE PREVIOUS 6 MONTHS
- HAVE SCORE < = 5.5 ON THE EDSS
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
- RECEIVE OR HAVE USED ANYTIME MONOCLONAL ANTIBODIES, MITOXANTRONE, CYTOTOXIC OR IMMUNOSUPPRESSIVE THERAPY (EXCLUDING SYSTEMIC STEROIDS AND ACTH), OR TOTAL LYMPHOID IRRADIATION
- HAVE RECEIVED WITHIN 3 MONTHS PRIOR TO BASELINE ANY APPROVED DISEASE-MODIFYING THERAPY FOR MS, CYTOKINE OR ANTI-CYTOKINE THERAPY, INTRAVENOUS IMMUNOGLOBULIN, PLASMAPHERESIS, ANY INVESTIGATIONAL DRUG, OR EXPERIMENTAL PROCEDURE
- HAVE RECEIVED WITHIN 30 DAYS PRIOR TO BASELINE ORAL OR SYSTEMIC CORTICOSTEROIDS OR ACTH
- HAVE KNOWN INTOLERANCE OR ANY CONTRAINDICATION TO BOTH IBUPROFEN AND TO PARACETAMOL/ACETAMINOPHEN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): THE DIFFERENCE BETWEEN THE NUMBER OF COMBINED UNIQUE (CU) ACTIVE MRI LESIONS AT WEEK 16 IN THE RNF GROUP (GROUP 1) VS THE PLACEBO GROUP (GROUP 2);Main Objective: TO EVALUATE THE EFFICACY OF REBIF NEW FORMULATION (RNF), COMPARED TO PLACEBO, IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS AND ACTIVE DISEASE BY MEANS OF MRI AT THE END OF 16 WEEKS OF TREATMENT;Secondary Objective: TO EVALUATE THE EFFICACY OF RNF BY COMPARING THE MEAN NUMBER OF COMBINED UNIQUE LESIONS PER SCAN PER SUBJECT BETWEEN THE INITIAL 16 WEEKS OF PLACEBO TREATMENT AND 24 WEEKS OF RNF TREATMENT IN THE SAME SUBJECTS ORIGINALLY RANDOMIZED TO PLACEBO
- Secondary Outcome Measures
Name Time Method