Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00520572 | A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA) | PHASE2 | COMPLETED | 385 | — | — | Aug 1, 2007 | Mar 1, 2009 | Feb 4, 2013 | 51 | United States, Argentina +10 |
| NCT00700986 | Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056 | PHASE1 | COMPLETED | 12 | — | — | Jun 1, 2008 | Aug 1, 2008 | Dec 1, 2010 | 1 | United Kingdom |
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Etanercept 50mg, subcutaneous, once weekly |
| 2 | EXPERIMENTAL | 50mg oral, once daily |
| 3 | EXPERIMENTAL | 100 mg oral, once daily |
| 4 | EXPERIMENTAL | 200 mg oral, once daily |
| 5 | EXPERIMENTAL | 400mg once, daily |
| 6 | PLACEBO_COMPARATOR | oral, once daily |
| Name | Type | Description |
|---|---|---|
| AZD9056 | DRUG | - |
| Etanercept | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of po...