Clarity Extension Study - Full Text View

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00641537

Purpose

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
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)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Cladribine

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Safety evaluations include clinical laboratory testing, EKGs and review of adverse events. [ Time Frame: Safety will be evaluated at every visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Neurological assessments will be performed at various timeponts ] [ Designated as safety issue: No ]

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
1: Experimental Cladribine at low dose throughout the 2-year extension trial	Drug: Oral Cladribine low dose oral cladribine (for a total exposure of 3.5 mg/kg over the two year extension)
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	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)
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.	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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641537

Show 29 Study Locations

Sponsors and Collaborators

EMD Serono

More Information

No publications provided

Responsible Party:	EMD Serono ( Steven Greenberg, M.D. )
Study ID Numbers:	27820
Study First Received:	March 13, 2008
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00641537 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cladribine
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis

Immunosuppressive Agents
Multiple Sclerosis, Relapsing-Remitting
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009