Clinical trial NCT00202995: Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS
Official title: A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

1. Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
2. Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
3. 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.
4. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
5. Patients must be between the ages of 18 and 50 years inclusive
6. 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
7. Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
8. Patients must be relapse-free and off corticosteroids between the screening and baseline visits
9. Patients must be willing and able to give written informed consent

Exclusion Criteria:

1. Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
2. Previous treatment with glatiramer acetate (injectable)
3. 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
4. Previous total body irradiation or total lymphoid irradiation
5. Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
6. Pregnancy or breastfeeding
7. Life-threatening or other clinically significant disease
8. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
9. A known sensitivity to gadolinium (gadolinium acid)
10. A known history of sensitivity to mannitol
11. Inability to successfully undergo MRI scanning

Primary outcomes:
measure: The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Helene Brooks
role: STUDY_DIRECTOR
References: