A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS
- Conditions
- Relapsing-remitting multiple sclerosis (RRMS)MedDRA version: 7.0Level: PTClassification code 10028245
- Registration Number
- EUCTR2004-005148-28-FI
- Lead Sponsor
- Merck Serono International S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1290
The subjects must fulfill all of the following criteria prior to Study Day 1:
- Be male or female, between 18 and 65 years of age (inclusive, at time of informed consent)
- Have definite MS according to the McDonald criteria
- Have relapsing-remitting disease with one or more relapses within twelve months prior to Study Day 1
- Must be clinically stable and not have had a relapse within 28 days prior to Study Day 1
- Have MRI consistent with MS at the Pre-Study Evaluation, according to the Fazekas criteria
- Have an EDSS from 0-5.5, inclusive
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
The subjects must not meet any of the following criteria:
- Have Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS)
- Prior use of Disease Modifying Drugs (DMDs) within the last three months prior to Study Day 1
- Have previously failed treatment with two or more DMDs on the basis of efficacy (could have previously failed treatment based on tolerability and/or convenience)
- Prior or current history of malignancy
- History of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy
- Have platelet and absolute neutrophil counts below the lower limits of normal range within 28 days prior to Study Day 1
- Have significant leukopenia (white blood cell count <0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Cladribine versus Placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS.;Secondary Objective: - To assess the effect of Cladribine on progression of disability in subjects with RRMS<br>- To assess the effect of Cladribine in reducing the lesion activity compared to placebo as measured by MRI in subjects with RRMS<br>- To assess the safety of Cladribine in subjects with RRMS<br>- To assess population pharmacokinetics in subjects with RRMS<br>- To identify DNA polymorfisms or gene expression profiles associated with certain traits (i.e. response, adverse events) of cladribine used in the treatment of multiple sclerosis as well as potential susceptibility loci for multiple sclerosis;Primary end point(s): The primary endpoint is qualifying relapse rate at 96 weeks
- Secondary Outcome Measures
Name Time Method