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This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A4I Antagonist | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | 1113 | Bulgaria | ||||
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| Sofia |
| 1309 |
| Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Edmonton | Alberta | T6G 2G3 | Canada |
| Vancouver | British Columbia | V6T 2B5 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hull | Quebec | J8Y 1W7 | Canada |
| Hradec Králové | 500 05 | Czechia |
| Ostrava | Czechia |
| Prague | 845 15 | Czechia |
| Marburg | 35033 | Germany |
| Regensburg | 93053 | Germany |
| Tübingen | 72076 | Germany |
| Ulm | 89081 | Germany |
| Gdansk | 80-952 | Poland |
| Lodz | 90-153 | Poland |
| Lublin | 20-954 | Poland |
| Szczecin | 71-242 | Poland |
| Warsaw | 02-957 | Poland |
| Moscow | 117997 | Russia |
| Moscow | 123367 | Russia |
| Nizhny Novgorod | 603076 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 197089 | Russia |
| Banská Bystrica | 975 17 | Slovakia |
| Bratislava | 813 69 | Slovakia |
| Košice | 041 66 | Slovakia |
| Nitra | 949 01 | Slovakia |
| Barcelona | 08035 | Spain |
| Barcelona | 08907 | Spain |
| Madrid | 28040 | Spain |
| Málaga | 29010 | Spain |
| Seville | 41071 | Spain |
| Liverpool | L9 1AE | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham | NG7 2UH | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| 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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