A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1100

Inclusion Criteria

° Were randomised in Trial 25643 and satisfy one of the following:
- Completed their randomised treatment course and scheduled visits for the full 96 week or
- Did not complete the randomized treatment course in Trial 25643, but who elected to receive rescue treatment with Rebif or another DMD, and who completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomised treatment course in Trial 25643, declined rescue with Rebif or another DMD, and still completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomised treatment course in Trial 25643, were not eligible for rescue option with Rebif, and still completed scheduled clinic visits for the full 96
weeks.

° Be male or female and between 18 and 65 years of age (inclusive, at time of informedconsent prior to entry into Trial 25643)
° Must weigh between 40-120 kg, inclusive
° Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
- Be post-menopausal or surgically sterilized; or
- Using a highly effective method of contraception for the duration of the study. A highly effective method of contraception is defined as those which result in a low failure rate. less that 1% per year) when used consistently and correctly such as implants, i.e injectables, comined with oral contraceptives, IUSs, sexual abstinence or vasectomised partner.
- Treatment of pregnant and nursing women with cladribine is prohibited.
- If male he must be willing to use contraception to avoid pregnancies ,
- Subject must be willing and able to participate in the trial and have provided written informed consent,
- Voluntarily provide written informed consent, and for USA sites only, a subject
authorization under Health Insurance Portability and Accountability Act (HIPAA)

Females of childbearing potential, who are either subjects in the trial or who are partners to male subject in the trial must use one of the above means of contraception for the entire trial period and for at le t as 12 weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential is defined as:All female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive.”

Adequate contraception is defined as two barrier methods, or one barrier method with spermicide,or intrauterine device or use of the oral female contraceptive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

° History of, or available abnormal laboratory results indicative of any significant or unstable cardiac, endocrinologic, hematologic (other than abnormal laboratory results consistent with prior exposure to oral cladribine), hepatic, immunologic (other than MS), metabolic,urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), and/or other major disease, that would preclude the administration of oral cladribine over a 24-month course of treatment.

° Concurrent enrolment in any other investigational drug trial with the exception of any Sponsor sub-trial of this protocol that is approved by the Medical Director

° Any other reason(s) that, in the opinion of the Investigator and/or the Sponsor, would indicate that the subject is unsuitable for inclusion in this extension trial

°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

° Have signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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