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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00213135 |
The purpose of the study is to determine if cladribine is a safe and effective treatment for relapsing-remitting MS
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Cladribine Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1326 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Cladribine
Cladribine low dose (0.875 mg/kg/cycle)
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2: Experimental |
Drug: Cladribine
Cladribine high dose (0.875 mg/kg/cycle)
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3: Placebo Comparator |
Other: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany ( Stephanie Roberts, MSc., Clinical Trial Leader ) |
Study ID Numbers: | 25643 |
Study First Received: | September 13, 2005 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00213135 |
Health Authority: | United States: Food and Drug Administration |
Cladribine Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions |