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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00436826 |
The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS.
This study will randomize 200 subjects from approximately 50 sites located world-wide, who have experienced at least one relapse while taking Interferon-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) patients, who are still experiencing relapses, and patients who have received disease modifying drugs (DMDs), other than Interferon-beta therapy, during their MS treatment history, but are currently on Interferon-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.
Subjects will be randomised in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with Interferon-beta therapy. Total subject participation is 104 weeks.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Cladribine Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-Beta (IFN-b) Treatment in Multiple Sclerosis Subjects With Active Disease |
Estimated Enrollment: | 200 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | November 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cladribine
Cladribine will be administered in the form of a pill. Subjects will receive up to 4 cycles of cladribine in combination with their interferon therapy over a period of 2 years. A cycle is defined as daily administration given consecutively over 4 to 5 days. Subjects will receive 0.875 mg/kg/cycle. Cycles will be administered on Study Day 1, Weeks 5, 48 and 52 of the study. |
2: Placebo Comparator |
Other: Placebo
This treatment arm is identical to treatment arm #1 with the exception that subjects will receive placebo instead of cladribine.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
SD 1 (see also Section Error! Reference source not found. for further Hematological Testing and Entry Guidelines):
Platelet count = 140 - 450 x10E3/UL
be post-menopausal or surgically sterilized.
Exclusion Criteria:
United States, Massachusetts | |
US Medical Information | Recruiting |
Rockland, Massachusetts, United States, 02370 | |
Contact: US Medical Information 888-275-7376 |
Study Director: | Steven Greenberg, MD | EMD Serono, Inc |
Responsible Party: | EMD Serono ( Steven Greenberg, MD, Global Clinical Development Unit, Neurology ) |
Study ID Numbers: | 26593 |
Study First Received: | February 15, 2007 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00436826 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Relapsing forms Interferon-beta therapy |
Cladribine Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases Interferons |
Interferon-beta Demyelinating Autoimmune Diseases, CNS Sclerosis Immunosuppressive Agents Antiviral Agents Autoimmune Diseases of the Nervous System |
Cladribine Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons |
Interferon-beta Sclerosis Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |