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-LV
• Lead Sponsor: Serono International S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-11
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1290

Inclusion Criteria

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

Exclusion Criteria

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.;Primary end point(s): The primary endpoint is qualifying relapse rate at 96 weeks;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 polymorphisms or gene expression profiles associated with<br>certain traits (i.e. response, adverse events) of cladribine used in the treatment of<br>multiple sclerosis as well as potential susceptibility loci for multiple sclerosis