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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001133-16 | EudraCT Number |
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This randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with psoriatic arthritis who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | multiple doses |
| |
| RO5310074 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL) | 12 weeks | |
| Pharmacodynamics (anti-drug-antibodies) | 25 weeks |
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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 |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Drug |
multiple ascending doses |
|
| Los Angeles |
| California |
| 90036 |
| United States |
| Miami | Florida | 33169 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Dallas | Texas | 75231 | United States |
| San Antonio | Texas | 78217 | United States |
| Melbourne | Victoria | 3004 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Christchurch | 8011 | New Zealand |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |