CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 21, 2009

Start Date ^ICMJE

January 2005

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the efficacy of cladribine versus placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS. [ Time Frame: During 96 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To evaluate the efficacy of cladribine versus placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS.

Change History

Complete list of historical versions of study NCT00213135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the effect of cladribine on progression of disability in subjects with RRMS [ Time Frame: At 96 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

· To assess the effect of cladribine on progression of disability in subjects with RRMS

Descriptive Information

Brief Title ^ICMJE

CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS

Official Title ^ICMJE

A Phase III, Randomized, Double-Blind, Three-Arm, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis

Brief Summary

The purpose of the study is to determine if cladribine is a safe and effective treatment for relapsing-remitting MS

Detailed Description

This will be a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study will include a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period during Year 1; and a retreatment period during Year 2.

During the initial treatment period in Year 1, eligible subjects will be equally randomised by a central randomisation system to receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles + placebo for two cycles); b) cladribine at a high dose (0.875 mg/kg/cycle for four cycles); or c) placebo (four cycles). During the retreatment period in Year 2, subjects will receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles); or b) placebo (two cycles).

For all randomized subjects, there will be a rescue option of treatment with Rebif (44 mcg three times a week (tiw)) if the subject experiences more than one qualifying relapse, and/or experiences a sustained increase in their EDSS of ³one point, or ³1.5 points if baseline EDSS was 0, (over a period of three months or greater), during a calendar year beginning at Week 24.

To maintain the blind, there will be a Treating Physician who will view clinical laboratory results and assess AEs and safety information, and an independent blinded Evaluating Physician who will perform neurological exams. A central neuroradiology center, also blinded to treatment, will assess MRI evaluations.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: Cladribine
Other: Placebo

Study Arms / Comparison Groups

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

Active, not recruiting

Enrollment ^ICMJE

1326

Completion Date

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 -65 years of age
Definite MS according to the McDonald criteria
Relapsing-remitting disease with 1 or more relapses within 12 months
No relapse within 28 days
MRI consistent with MS
EDSS from 0-5.5
Weigh between 40-120 kg
Males and females must use contraception

Exclusion Criteria:

Pregnant or breast feeding
Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS)
Prior use of disease modifying drugs (DMDs) within the last 3 months, or 2 or more prior treatment failures with DMDs
Compromised immune function or infection, or prior use of medications that altered the immune system
Significant clinical or laboratory abnormalities at the screening visit (abnormal platelet, neutrophil or white blood cell counts)
Prior or current history of malignancy
History of blood disorders after immunosuppressive therapy
Systemic disease or psychiatric disorder that might interfere with subject safety, compliance or evaluation of MS
Use of any investigational drug or experimental procedure within 6 months

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00213135

Responsible Party

Stephanie Roberts, MSc., Clinical Trial Leader, Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany

Study ID Numbers ^ICMJE

25643

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Steven Greenberg, M.D.

EMD Serono, Inc.

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