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Clarity Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00641537
First received: March 13, 2008
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

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, ECGs 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 timepoints ] [ Designated as safety issue: No ]

Enrollment: 867
Study Start Date: February 2008
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Oral Cladribine
Subject on Placebo during 25643 will be re-randomized to low dose cladribine for 2 years
Experimental: 2 Drug: Oral Cladribine
Subject to low dose or high dose during 25643 will be re-randomized in a 2:1 allocation ratio to receive either low dose cladribine or placebo for 2 years

  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 117 Study Locations
Sponsors and Collaborators
EMD Serono
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00641537     History of Changes
Other Study ID Numbers: 27820
Study First Received: March 13, 2008
Last Updated: September 7, 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 19, 2013