A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Cladribine

Criteria

Inclusion Criteria:

• Male or female, between 18 and 65 years of age (inclusive, at time of informed consent)

• Has definite MS according to the McDonald criteria

• Has relapsing-remitting disease with 1 or more relapses within 12 months prior to Study Day 1

• Must have been clinically stable and not has a relapse within 28 days prior to Study Day 1

• Has MRI consistent with MS at the pre-study evaluation according to the Fazekas criteria

• Has a EDSS score from 0 to 5.5, inclusive

• Weighed between 40-120 kilogram (kg), inclusive

• If female, she must:

1. be post-menopausal or surgically sterilized; or

2. uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and

3. be neither pregnant nor breast-feeding

• If male, he must be willing to use contraception to avoid pregnancies

• Be willing and able to comply with study procedures for the duration of the study

• Voluntarily provides written informed consent, and for United states of America (USA) sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA)

Exclusion Criteria:

• Has 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 on the basis of efficacy

• Has significant leukopenia (white blood cell count less than 0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1

• Has received cladribine, mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab

• Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1

• Has compromised immune function or infection

• Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1

• Has received cytokine-based therapy, intravenous immunoglobulin therapy, or plasmapheresis within 3 months prior to Study Day 1

• Has platelet and absolute neutrophil counts below the lower limit of normal range within 28 days prior to Study Day 1

• Has prior or current history of malignancy

• Has a history of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy

• Has systemic disease that, in the opinion of the Investigator, might interfere with subject safety, compliance or evaluation of the condition under Study (for example, insulin-dependent diabetes, Lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)

• Has a psychiatric disorder that, in the opinion of the Investigator, was unstable or would preclude safe participation in the study

• Has allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients

• Has used any investigational drug or experimental procedure within 6 months prior to Study Day 1