Clarity Extension Study
Information source: EMD Serono
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis
Intervention: Oral Cladribine (Drug); Oral Cladribine (Drug); Oral Cladribine (Drug)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: EMD Serono
Summary
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Safety evaluations include clinical laboratory testing, EKGs and review of adverse events.
Secondary outcome: Efficacy will be evaluated on an annual basis and cumulatively over the duration of the 4 year study. Subjects will be evaluated with neurological exam for progression of disease and time to disability as well burden of disease as demonstrated on MRI.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with Relapsing-Remitting Multiple Sclerosis
- Randomized in Trial 25643
- Be male or female and between 18 and 65 years of age (inclusive, at time of informed
consent prior to entry into Trial 25643)
- Must weigh between 40-120 kg, inclusive
Exclusion Criteria:
- Subjects who were not enrolled in Oral Cladribine Protocol # 25643
- Subject has moderate to severe renal impairment
- Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h,
cyclophosphamide, azathioprine, methotrexate or natalizumab since their completion of
Trial 25643
- Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or
plasmapheresis since their completion of Trial 25643
- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within
28 days before Study Day 1
Locations and Contacts
Local Medical Info Office, Sydney, Australia
Local Medical Info Office, Zug, Austria
Local Medical Info Office, Den Haag, Belgium
Local Medical Informtion Office, Zug, Brazil
Local Medical Info Office, Zug, Bulgaria
Local Medical Info Office, Zug, Croatia
Local Medical Info Office, Zug, Czech Republic
Local Medical Info Office, Copenhagen, Denmark
Local Medical Info Office, Zug, Estonia
Local Medical Info Office, Vantaa, Finland
Local Medical Info Office, Paris, France
Local Medical Info Office, Munich, Germany
Local Medical Info Office, Athens, Greece
Local Medical Info Office, Roma, Italy
Local Medical Info Office, Zug, Latvia
Local Medical Info Office, Zug, Lebanon
Local Medical Info Office, Zug, Lithuania
Local Medical Info Office, Zug, Morocco
Local Medical Info Office, Den Haag, Netherlands
Local Medical Info Office, Zug, Poland
Local Medical Info Office, Zug, Russian Federation
Local Medical Info Office, Zug, Saudi Arabia
Local Medical Info Office, Zug, Serbia and Montenegro
Local Medical Info Office, Zug, Switzerland
Local Medical Info Office, Les Berges du Lac, Tunisia
Local Medical Info Office, Istanbul, Turkey
Local Medical Info Office, Zug, Ukraine
Local Medical Info Office, London, United Kingdom
Local Medical Info Office, Rockland, Massachusetts, United States
Additional Information
Starting date: February 2008
Last updated: March 21, 2008
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