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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00641537 |
The purpose of this extension trial is to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within trial Protocol 25643.
Condition | Intervention | Phase |
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Relapsing-Remitting Multiple Sclerosis |
Drug: Oral Cladribine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, ExtensionTrial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY) |
Estimated Enrollment: | 1100 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cladribine at low dose throughout the 2-year extension trial
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Drug: Oral Cladribine
low dose oral cladribine (for a total exposure of 3.5 mg/kg over the two year extension)
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2: Experimental
oral cladribine at the lower trial dose for two cycles in the first year oral cladribine for two cycles in the second year or placebo
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Drug: Oral Cladribine
Subjects will receive 2 cycles per year of low dose oral cladribine (for a total exposure of 3.5 mg/kg over two years)
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3: Experimental
oral cladribine low dose for two cycles in the first year oral cladribine low dose for two cycles in the second year or placebo throughout the 2 year extension trial.
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Drug: Oral Cladribine
subjects who received the lower trial dose oral cladribine in Year 1 and the lower trial dose in Year 2 of Trial 25643 will be randomized to receive either oral cladribine at the lower trial dose for two cycles in the first year followed by two cycles at the lower trial dose in the second year or placebo throughout the 2 year extension trial. It has been calculated that two thirds of subjects from this group will received cladribine and one third will receive placebo.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | EMD Serono ( Steven Greenberg, M.D. ) |
Study ID Numbers: | 27820 |
Study First Received: | March 13, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00641537 |
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 |