A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
Sponsored by AbbVie
About this study
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 6 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo. Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Substudy 4 will evaluate ABBV-8736 compared to Placebo. Substudy 5 will evaluate ABBV-701 compared to Placebo and Substudy 6 will be a proof of concept study of ABBV-848 in participants who are on a stable background of Methotrexate, with an Adalimumab reference arm. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at up to 200 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Where this study is enrolling (8)
- Call 619-334-4735
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
Chula Vista, California
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- Call 813-870-1292
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
Tampa, Florida
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- Call 312.926.2000
Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422
Chicago, Illinois
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- Call 814-693-0300
Altoona Center For Clinical Research /ID# 272479
Duncansville, Pennsylvania
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- Call 832-234-1023
Care & Cure Clinic /ID# 281684
Houston, Texas
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Show all 8 locations
- Call 972-288-2600
Southwest Rheumatology Research /ID# 272268
Mesquite, Texas
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- Call 713-487-8680
Arthritis Care Of Texas /ID# 277961
Corpus Christi, Texas
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- I'm interested
Fort Bend Rheumatology Associates /ID# 280761
Sugar Land, Texas
Who can participate
Inclusion criteria
- ✓At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
- ✓Participant must be on a stable dose of methotrexate (MTX)
Exclusion criteria
- ✕Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
- ✕History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
- ✕Sub-study 6 specific:
- ✕Prior exposure to any Interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor or degrader.
- ✕Prior exposure to any biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.