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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03086343 | A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs | PHASE3 | COMPLETED | 657 | — | — | May 9, 2017 | Jun 6, 2023 | Jul 18, 2024 | 161 | United States, Argentina +28 |
The Disease Activity Score (DAS) 28 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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| Primary Cohort: Abatacept/Upadacitinib 15 mg QD | ACTIVE_COMPARATOR | Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks. |
| Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD | EXPERIMENTAL | Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks. |
| 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD | EXPERIMENTAL | Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks. |
| 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD | ACTIVE_COMPARATOR | Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks. |
| Name | Type | Description |
|---|---|---|
| Abatacept | DRUG | IV infusion |
| Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion) | DRUG | IV infusion |
| Upadacitinib | DRUG | 15 mg extended release tablet |
| Placebo for upadacitinib | DRUG | Film-coated tablet |
Main Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA * Participants have been treated for ≥ 3 months prior to the screening visit wi...