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Abatacept · 1 trial · 1 indication
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...
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Abatacept is an investigational small molecule being studied for the treatment of Rheumatoid Arthritis (RA). It is being evaluated in patients with RA who have an inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs) and are on a stable dose of conventional synthetic DMARDs (csDMARDs).
Abatacept is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical research on this drug for the treatment of Rheumatoid Arthritis.
Abatacept is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study comparing it to another treatment in Rheumatoid Arthritis has been completed.
Abatacept was studied in a Phase 3 clinical trial with the identifier NCT03086343. This completed trial enrolled 657 participants and compared Abatacept to upadacitinib in subjects with Rheumatoid Arthritis on a stable dose of csDMARDs who had an inadequate response or intolerance to biologic DMARDs.
Abatacept is a small molecule immunology therapy. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not fully described here.
No, Abatacept is not the same as upadacitinib. In a Phase 3 clinical trial, Abatacept was compared directly against upadacitinib in patients with Rheumatoid Arthritis. The two drugs are distinct treatments being evaluated for the same condition.