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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02384538 | A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis | PHASE2 | COMPLETED | 132 | — | — | Mar 1, 2015 | Jul 1, 2016 | Aug 11, 2017 | - | — |
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. |
| ABT-981 | EXPERIMENTAL | ABT-981 200 mg every two weeks (Q2W) for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| ABT-981 | BIOLOGICAL | ABT-981 administered by subcutaneous injection |
| Placebo for ABT-981 | BIOLOGICAL | Placebo for ABT-981 administered by subcutaneous injection |
Inclusion Criteria: 1. Male or female between the ages of 35 to 80. 2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria 3. Must have radiographic evidence of erosive hand OA 4. Have one or more clinical signs and symptoms of active inflammation in at least ...