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| Descriptive Information Fields | |||||
| Brief Title † | CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS | ||||
| Official Title † | A Phase III, Randomized, 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 | ||||
| Brief Summary | The purpose of the study is to determine if cladribine is a safe and effective treatment for relapsing-remitting MS |
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| Detailed Description | This will be a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study will include a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period during Year 1; and a retreatment period during Year 2. During the initial treatment period in Year 1, eligible subjects will be equally randomised by a central randomisation system to receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles + placebo for two cycles); b) cladribine at a high dose (0.875 mg/kg/cycle for four cycles); or c) placebo (four cycles). During the retreatment period in Year 2, subjects will receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles); or b) placebo (two cycles). For all randomized subjects, there will be a rescue option of treatment with Rebif (44 mcg three times a week (tiw)) if the subject experiences more than one qualifying relapse, and/or experiences a sustained increase in their EDSS of ³one point, or ³1.5 points if baseline EDSS was 0, (over a period of three months or greater), during a calendar year beginning at Week 24. To maintain the blind, there will be a Treating Physician who will view clinical laboratory results and assess AEs and safety information, and an independent blinded Evaluating Physician who will perform neurological exams. A central neuroradiology center, also blinded to treatment, will assess MRI evaluations. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | To evaluate the efficacy of cladribine versus placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS. [ Time Frame: During 96 weeks ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | To assess the effect of cladribine on progression of disability in subjects with RRMS [ Time Frame: At 96 weeks ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Multiple Sclerosis, Relapsing-Remitting | ||||
| Intervention † | Drug: Cladribine Other: Placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 1326 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Switzerland | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00213135 | ||||
| Organization ID | 25643 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | EMD Serono | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | EMD Serono | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | September 29, 2008 | ||||