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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-000172-33 |
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The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASK8007 | Drug | IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability MD ASK8007 | up to 10 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| DAS28+CD68 | Day 43 compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven | 3000 | Belgium | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917822 | Background | Boumans MJ, Houbiers JG, Verschueren P, Ishikura H, Westhovens R, Brouwer E, Rojkovich B, Kelly S, den Adel M, Isaacs J, Jacobs H, Gomez-Reino J, Holtkamp GM, Hastings A, Gerlag DM, Tak PP. Safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the monoclonal antibody ASK8007 blocking osteopontin in patients with rheumatoid arthritis: a randomised, placebo controlled, proof-of-concept study. Ann Rheum Dis. 2012 Feb;71(2):180-5. doi: 10.1136/annrheumdis-2011-200298. Epub 2011 Sep 14. |
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| Drug |
IV |
|
| Budapest |
| 1027 |
| Hungary |
| Dublin | Ireland |
| Amsterdam | Netherlands |
| Groningen | Netherlands |
| A Coruña | Spain |
| Barcelona | Spain |
| Santiago | Spain |
| London | United Kingdom |
| Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C570079 | ASK8007 monoclonal antibody |
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