CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (MS)
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Purpose
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting MS
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Cladribine Tablets Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- 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 ]
- To assess the effect of cladribine on progression of disability in subjects with RRMS [ Time Frame: At 96 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 1326 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Cladribine Tablets
Cladribine low dose: 0.875 mg/kg/course for two courses in the first 48 weeks, followed by 0.875mg/kg/course for two courses in the second 48 weeks (Total dose 3.5mg/kg over 96 weeks)
|
| Experimental: 2 |
Drug: Cladribine Tablets
Cladribine high dose: 0.875 mg/kg/course for four courses in the first 48 weeks, followed by 0.875mg/kg/course for two courses in the second 48 weeks (Total dose 5.25mg/kg over 96 weeks)
|
| Placebo Comparator: 3 |
Other: Placebo
Placebo Tablets
|
Detailed Description:
This was a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study included a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period during weeks 1 to 48; and a retreatment period during weeks 49 to 96.
During the initial treatment period, weeks 1 to 48, eligible subjects were equally randomised by a central randomisation system to receive either a) cladribine at a low dose (0.875 mg/kg/course for two courses + placebo for two courses); b) cladribine at a high dose (0.875 mg/kg/course for four courses); or c) placebo (four courses). During the retreatment period in weeks 49 to 96, subjects received either a) cladribine at a low dose (0.875 mg/kg/course for two courses); or b) placebo (two courses).
For all randomized subjects, there was a rescue option of treatment with Rebif® (interferon beta-1a 44 mcg given subcutaneously three times a week) if the subject experienced more than one qualifying relapse, and/or experienced a sustained increase in their EDSS score of =/>1 point, or =/>1.5 points if baseline EDSS score was 0, (over a period of three months or greater), during a calendar year beginning at Week 24.
To maintain the blind, there was a Treating Physician who viewed clinical laboratory results and assess adverse events and safety information, and an independent blinded Evaluating Physician who performed neurological exams. A central neuroradiology center, also blinded to treatment, assessed MRI evaluations.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 -65 years of age
- Definite MS according to the McDonald criteria
- Relapsing-remitting disease with 1 or more relapses within 12 months
- No relapse within 28 days
- MRI consistent with MS according to the Fazekas criteria
- EDSS score from 0 to 5.5
- Weight between 40-120 kg
- Males and females must use contraception
Exclusion Criteria:
- Pregnant or breast feeding
- Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS)
- Prior use of disease modifying drugs (DMDs) within the last 3 months, or 2 or more prior treatment failures with DMDs
- Compromized immune function or infection
- Prior use of immunosuppressive therapy at any time before study
- Use of cytokine-based therapy, intravenous immunoglobulin therapy, or plasmapheresis within 3 months before study entry
- Significant clinical or laboratory abnormalities within 28 days before study entry (abnormal platelet, neutrophil or white blood cell counts)
- Prior or current history of malignancy
- History of blood disorders after immunosuppressive therapy
- Systemic disease or psychiatric disorder that might interfere with subject safety, compliance or evaluation of MS
- Use of any investigational drug or experimental procedure within 6 months
Contacts and Locations
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00213135 History of Changes |
| Other Study ID Numbers: | 25643 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Cladribine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013