Status:
COMPLETED
CLARITY Extension Study
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial ...
Eligibility Criteria
Inclusion
- Randomized in Trial 25643 and satisfied one of the following:
- Completed randomized treatment course and scheduled visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
- Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
- No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
- All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:
- Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
- Leukocytes (total white blood cell) = 4.1 to 12.3\*10\^3 per microliter
- Absolute lymphocyte count (ALC) = 1.02 to 3.36\*10\^3 per microliter
- Absolute neutrophil count (ANC) = 2.03 to 8.36\*10\^3 per microliter
- Platelet count = 140 to 450\*10\^3 per microliter
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
- Participants who were not enrolled in Trial 25643
- Participant has moderate to severe renal impairment
- Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
- Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Key Trial Info
Start Date :
February 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
867 Patients enrolled
Trial Details
Trial ID
NCT00641537
Start Date
February 29 2008
End Date
December 31 2011
Last Update
December 7 2020
Active Locations (116)
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Research Site
Boulder, Colorado, United States
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Research Site
Atlanta, Georgia, United States
3
Research Site
Chicago, Illinois, United States
4
Research Site
Northbrook, Illinois, United States