Status:
TERMINATED
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Lead Sponsor:
AbbVie
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants...
Detailed Description
Participants were randomly assigned at a ratio of 1:1:1:1:1 to ABBV-154 at either 40 mg, 150 mg, 340 mg, subcutaneously (SC) EOW; 340 mg SC every 4 weeks (E4W); or placebo SC EOW. Randomization was st...
Eligibility Criteria
Inclusion
- Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
- Participant has \>= 6 swollen joints (based on 66 joint count) and \>=6 tender joints (based on 68 joint count) at baseline.
- Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
- Participants must be on stable dose of methotrexate (MTX).
Exclusion
- \- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2023
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT04888585
Start Date
June 23 2021
End Date
August 4 2023
Last Update
October 8 2024
Active Locations (220)
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1
Elite Clinical Studies, LLC /ID# 228227
Phoenix, Arizona, United States, 85018
2
Arthritis and Rheumatism Associates /ID# 228201
Jonesboro, Arkansas, United States, 72401-6251
3
Providence Medical Foundation /ID# 228104
Fullerton, California, United States, 92835
4
Care Access Research, Huntington Beach /ID# 228163
Huntington Beach, California, United States, 92648