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 ( SELECT-CHOICE ) (SELECT-CHOICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03086343|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis (RA)||Drug: Upadacitinib matching placebo Drug: Abatacept matching placebo Drug: Upadacitinib Drug: Abatacept||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||614 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)|
|Actual Study Start Date :||May 9, 2017|
|Estimated Primary Completion Date :||February 29, 2020|
|Estimated Study Completion Date :||June 7, 2022|
Active Comparator: Abatacept followed by upadacitinib
Intravenous (IV) infusion of abatacept at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20 followed by upadacitinib starting at week 24 up to 5 years.
Drug: Upadacitinib matching placebo
Once daily for 24 weeks during Period 1 and up to 5 years during Period 2.
Drug: Abatacept matching placebo
Other Name: ABT-494
- Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (non-inferiority) [ Time Frame: At week 12 ]The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
- Proportion of participants achieving Disease Activity Score (DAS) 28 based Clinical Remission (CR) [ Time Frame: At week 12 ]Proportion of participants achieving Clinical Remission (CR) as defined by a clinical response Disease Activity Score (DAS)28 C-Reactive Protein (CRP) less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates CR.
- Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (superiority) [ Time Frame: At week 12 ]The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086343
Show 162 Study Locations
|Study Director:||AbbVie Inc.||AbbVie|