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Slow enrollment decreased sample size No unexpected safety issues.
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Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Glatiramer Acetate 20 mg s.c. daily |
|
| 2 | Active Comparator | Betaseron 250 ug every other day or Rebif 44 ug 3 times a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate | Drug | 20 mg s.c. daily |
| |
| Betaseron |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Brooks | Teva Neuroscience, Inc. | Study Director |
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| Drug |
250 mg every other day |
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| Rebif | Drug | 44 ug 3 times a week |
|
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D000068576 | Interferon beta-1b |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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