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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002204-33 | EudraCT Number |
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The study was discontinued due to unfavorable interim analysis
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP323 1000 mg/day | Experimental |
| |
| CDP323 500 mg/day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP323 | Drug | 250 mg capsules, 500 mg bid (1000 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28). | The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images. | Cumulative number of newly active lesions from baseline to Week 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment emergent adverse event. | During up to 24 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman | Alabama | United States | ||||
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| placebo |
| Drug |
capsules, once daily |
|
| CDP323 | Drug | 250 mg Capsules, 500 mg, once daily |
|
| Phoenix |
| Arizona |
| United States |
| Tucson | Arizona | United States |
| Springs | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Maitland | Florida | United States |
| Atlanta | Georgia | United States |
| Northbrook | Illinois | United States |
| Fort Wayne | Indiana | United States |
| Kansas City | Kansas | United States |
| Lenexa | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Farmington Hills | Michigan | United States |
| Charlotte | North Carolina | United States |
| Columbus | Ohio | United States |
| Providence | Rhode Island | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Kirkland | Washington | United States |
| Charleston | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Diepenbeek | Belgium |
| Ghent | Belgium |
| Melsbroek | Belgium |
| Overpelt | Belgium |
| Sijsele | Belgium |
| Sint-Truiden | Belgium |
| London | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Gatineau | Quebec | Canada |
| Greenfield Park | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Oulu | Finland |
| Tampere | Finland |
| Turku | Finland |
| Besançon | France |
| Clermont-Ferrand | France |
| Lyon | France |
| Rennes | France |
| Strasbourg | France |
| Bayreuth | Germany |
| Berlin | Germany |
| Giessen | Germany |
| Hamburg | Germany |
| Marburg | Germany |
| Rostock | Germany |
| Ulm | Germany |
| Wiesbaden | Germany |
| Budapest | Hungary |
| Győr | Hungary |
| Nyíregyháza | Hungary |
| Pécs | Hungary |
| Amsterdam | Netherlands |
| Breda | Netherlands |
| Nieuwegein | Netherlands |
| Nijmegen | Netherlands |
| Barcelona | Spain |
| Bilbao | Spain |
| Girona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Oviedo | Spain |
| Santa Cruz de Tenerife | Spain |
| Seville | Spain |
| Gothenburg | Sweden |
| Umeå | Sweden |
| Hartshill | United Kingdom |
| Newcastle | United Kingdom |
| Nottingham | United Kingdom |
| Sheffield | 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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| ID | Term |
|---|---|
| C584644 | CDP323 |
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