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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00713544 | A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 373 | — | — | Jul 1, 2008 | Apr 1, 2009 | Oct 3, 2011 | 49 | Bulgaria, Colombia +12 |
| NCT00887770 | A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart | PHASE1 | COMPLETED | 64 | — | — | Apr 1, 2009 | Jul 1, 2009 | Jul 16, 2009 | 1 | United Kingdom |
| NCT00871767 | AZD5672 Bioavailability Study in Healthy Male and Female Subjects | PHASE1 | COMPLETED | 24 | — | — | Mar 1, 2009 | May 1, 2009 | Jun 30, 2009 | 1 | United Kingdom |
| NCT00711074 | Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers | PHASE1 | COMPLETED | 4 | — | — | Jun 1, 2008 | Jul 1, 2008 | Apr 9, 2009 | 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 12 Weeks' treatment.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | 20mg |
| 3 | EXPERIMENTAL | 50mg |
| 4 | EXPERIMENTAL | 100mg |
| 5 | EXPERIMENTAL | 150mg |
| 6 | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | 600mg AZD5672 + Moxifloxacin placebo |
| B | EXPERIMENTAL | 100mg AZD5672 + Moxifloxacin placebo |
| C | ACTIVE_COMPARATOR | AZD5672 placebo + Moxifloxacin 400mg |
| D | PLACEBO_COMPARATOR | AZD5672 placebo + Moxifloxacin placebo |
| Name | Type | Description |
|---|---|---|
| AZD5672 | DRUG | 20 mg oral, once daily |
| Etanercept | DRUG | 50 mg, subcutaneous injection, weekly |
| Placebo | DRUG | placebo, oral, once daily |
| Moxifloxacin | DRUG | 1 x 400mg capsule, oral, single dose |
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 of positive rheumatoid f...