Status:
TERMINATED
Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
- Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
- Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
- Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
- Patients must be between the ages of 18 and 50 years inclusive
- Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy
- Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
- Patients must be relapse-free and off corticosteroids between the screening and baseline visits
- Patients must be willing and able to give written informed consent
Exclusion
- Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
- Previous treatment with glatiramer acetate (injectable)
- Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
- Previous total body irradiation or total lymphoid irradiation
- Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
- Pregnancy or breastfeeding
- Life-threatening or other clinically significant disease
- Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
- A known sensitivity to gadolinium (gadolinium acid)
- A known history of sensitivity to mannitol
- Inability to successfully undergo MRI scanning
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00202995
Start Date
July 1 2004
End Date
October 1 2007
Last Update
October 18 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.