Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0 Level: PT Classification code 10028245
Conditions
Interventions
Product Name: Cladribine
Product Code: Not Applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Concentration unit: mg millig
Sponsors
Merck Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To assess the effect of Cladribine in reducing the lesion activity compared to placebo as measured by MRI in subjects with RRMS - To assess the safety of Cladribine in subjects with RRMS - To assess population pharmacokinetics in subjects with RRMS - 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 | — |
Countries
Czech Republic, Denmark, Estonia, Finland, Germany, Italy, Latvia, Lithuania, United Kingdom
Outcome results
None listed