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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02531178 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 8 | — | — | Jul 1, 2015 | Feb 1, 2016 | Mar 3, 2016 | 1 | Germany |
This will be collected through out the study
Vital signs including blood pressure and heart rate will be assessed
Changes in any physical exam assessed by the physician will be assessed.
ECG measurements will be assessed
This will be assessed using non-compartmental methods.
This will be assessed using non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| low dose ABBV-257 | EXPERIMENTAL | Low dose every other week (eow), Weeks 0-8 |
| Medium dose of ABBV-257 | EXPERIMENTAL | Medium dose every other week (eow), Weeks 0-8 |
| high dose of ABBV-257 | EXPERIMENTAL | high dose every other week (eow), Weeks 0-8 |
| Name | Type | Description |
|---|---|---|
| ABBV-257 | BIOLOGICAL | subcutaneous injection |
| Placebo | BIOLOGICAL | Placebo for ABBV-257 |
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, or ACR 1987 for patients with diagnosis prior 2011 ≥ 3 months. * Except for methotrexate (MTX), the subject must have discontinued al...