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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03823391 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | PHASE2 | COMPLETED | 48 | — | — | Mar 27, 2019 | Aug 26, 2020 | Jul 19, 2021 | 30 | United States, Germany +5 |
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| ABBV-3373 Followed by Placebo | EXPERIMENTAL | Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22. |
| Adalimumab | EXPERIMENTAL | Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22. |
| Name | Type | Description |
|---|---|---|
| ABBV-3373 | DRUG | ABBV-3373 is administered as intravenous (IV) infusion |
| Placebo for ABBV-3373 | DRUG | Placebo for ABBV-3373 is administered as IV infusion |
| Adalimumab | DRUG | Adalimumab is administered as subcutaneous (SC) injection |
| Placebo for adalimumab | DRUG | Placebo for adalimumab is administered as subcutaneous (SC) injection |
Inclusion Criteria: * Participant has the clinical diagnosis of RA for \> 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria. * Participant meets the following disease activity criteria: \>= 4 swo...