Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS
What it found
The trial was stopped early for safety reasons.
Reason given: Slow enrollment decreased sample size No unexpected safety issues.
This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
Compared with
- Interferon beta-1b
Interferon alpha/beta receptor agonist
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
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.
Relapses
Who could take part
Relapsing MS · 18 to 50
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®
Loading reviews and guidelines…
Related trials
- TWINS
Phase 3 · Not yet recruiting
Still running
- AIOLOS
Recruiting
Still running
- Full Responders
Phase 4 · Stopped early
Stopped early
- A Study to Learn More About The Safety of Diroximel Fumar…
Running, not recruiting
Still running
- A Open-label Study to Assess Response to COVID-19 Vaccine…
Phase 4 · Stopped early
Stopped: safety
- A Study to Asses Efficacy, Safety and Tolerability of Mon…
Phase 3 · Completed
Met its main goal
History
Started
Jul 2004
Main results due
Oct 2007
Finished
Oct 2007
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error