The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
Signed and dated informed consent obtained before undergoing any trial-specific procedure.
Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.
Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)
Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.
Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.
Current inflammatory joint disease other than RA.
Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.
Parallel
AP1189, 40 mg
DrugAP1189 tablets for oral use
AP1189, 70 mg
DrugAP1189 tablets for oral use
AP1189, 100 mg
DrugAP1189 tablets for oral use
AP1189 matching placebo
DrugAP1189 tablets for oral use
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP)
Absolute change from baseline in DAS28-CRP at Week 12
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SynAct Pharma Aps
Lead sponsor
NBCD A/S
Collaborator
