Clarity Extension Study - Tabular View

Tracking Information
First Received Date ^ICMJE	March 13, 2008
Last Updated Date	March 21, 2009
Start Date ^ICMJE	February 2008
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00641537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Clarity Extension Study
Official Title ^ICMJE	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)
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition ^ICMJE	Relapsing-Remitting Multiple Sclerosis
Intervention ^ICMJE	Drug: Oral Cladribine
Study Arms / Comparison Groups	Experimental: Cladribine at low dose throughout the 2-year extension trial 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 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.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	1100
Completion Date
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Latvia, Lebanon, Lithuania, Morocco, Netherlands, Poland, Russian Federation, Saudi Arabia, Serbia, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00641537
Responsible Party	Steven Greenberg, M.D., EMD Serono
Study ID Numbers ^ICMJE	27820
Study Sponsor ^ICMJE	EMD Serono
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	EMD Serono
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP