Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Lead Sponsor:
AbbVie
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with a...
Detailed Description
This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period. In the active-controlled period of the first 12 weeks of treatment, participants are...
Eligibility Criteria
Inclusion
- 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 swollen joints (based on 28 joint count) and \>= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) \>= 3.2 at Screening.
- Participant has an incomplete response to methotrexate. Participants must have been on oral or parental MTX therapy \>= 3 months and on a stable prescription of 15 to 25 mg/week (or \>= 10 mg/week in participants intolerant of MTX at doses \>= 15 mg/week) for \>= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Exclusion
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03823391
Start Date
March 27 2019
End Date
August 26 2020
Last Update
July 19 2021
Active Locations (30)
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1
Rheum Assoc of North Alabama /ID# 213626
Huntsville, Alabama, United States, 35801
2
AZ Arthritis and Rheum Researc /ID# 208515
Phoenix, Arizona, United States, 85032
3
C.V. Mehta MD, Med Corporation /ID# 213068
Hemet, California, United States, 92543
4
Robin K. Dore MD, Inc /ID# 213045
Tustin, California, United States, 92780