Clinical Trial 42497

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Upland, CA 91786


Study Summary:

phase 2 study to evaluate safety and efficacy of ABBV-105 and ABBV-599 (ABBV-105 plus upadacitinib) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs(bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.


Criteria:

• Adult male or female, at least 18 years old.

• Diagnosis of RA for ≥ 3 months based on the 2010 ACR/EULAR classification criteria for RA.

• Subject meets the following minimum disease activity criteria:
○ ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; and
○ hsCRP ≥ 3 mg/L (central lab) at Screening Visit.

• Subjects must have been treated for ≥ 3 months with ≥ 1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.

• Subjects must have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
○ The following csDMARDs are allowed (stable dose for
≥ 4 weeks prior to the first dose of study drug): oral or
parenteral methotrexate (MTX) (7.5 to 25 mg/week),
sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400
mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20
mg/day).
○ A combination of up to two background csDMARDs is allowed
EXCEPT the combination of MTX and leflunomide.


Qualified Participants May Receive:

Free patient care, Blood results. and if qualify and enroll into study compensation. 


Study is Available At:

Inland Rheumatology Clinical Trials. Inc
1238 E. Arrow hwy
Upland, CA 91786
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.