Apr 01, 2009
MS Trial Alert: Study of Oral Cladribine Added on to Interferon Therapy Recruiting Worldwide
Summary: Investigators at approximately 30 sites in the United States and others nationwide are studying the safety and tolerability of oral cladribine (EMD Serono Inc.) compared to placebo as an add-on therapy to injectable interferon beta-1a therapy – Rebif® (EMD Serono and Pfizer), Avonex® (Biogen Idec), or Betaseron® (Bayer Healthcare Pharmaceuticals) – in people with active MS. A total of 200 people are expected to enroll in this study. EMD Serono Inc. is sponsoring this study.
Rationale: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine has been used to treat hairy cell leukemia. Studies have suggested a potential benefit in people with certain types of MS. Cladribine has been designated by the FDA as a “Fast Track Product,” which should expedite its future review.
Eligibility and Details: Participants should be between 18 and 65 years of age, and have relapsing forms of MS, such as relapsing-remitting or secondary-progressive MS with superimposed relapses. Participants will have experienced at least one relapse while receiving interferon therapy for at least 48 weeks prior to enrollment
Participants will be randomly assigned to one of two treatment groups, cladribine or placebo, while remaining on their interferon therapy. Cladribine or placebo will be administered in the form of tablets taken in cycles. Each cycle lasts 4-5 days, and the number of tablets is determined by body weight. Four cycles of cladribine or placebo will be administered: two cycles in the first year of the study, and two more cycles in the second year.
The primary endpoint of the study is to determine the safety and tolerability of this combination. Secondary endpoints include disease activity on MRI scans, relapse rate, and disability progression.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please call 1-877-676-6924 or visit www.msonward.com. U.S. Sites are located in the following cities:
Tucson, AZ
Phœnix, AZ
Los Angeles, CA
Boulder, CO
Fort Collins, CO
Tampa, FL
Orlando, FL
Atlanta, GA
Chicago, IL
Peoria, IL
St Louis, MO
Charlotte, NC
Winston-Salem, NC
Newark, NJ
Albuquerque, NM
Rochester, NY
Stony Brook, NY
Columbus, OH
Philadelphia, PA
Pittsburgh, PA
Nashville, TN
Round Rock, TX
Houston, TX
San Antonio, TX
Burlington, VT
Tacoma, WA
Charleston, WV
Washington, DC
Rebif is a registered trademark of EMD Serono and Pfizer.
Avonex is a registered trademark of Biogen Idec.
Betaseron is a registered trademark of Bayer Healthcare Pharmaceuticals.