SHS_280184 MEAP CCLG 18178
A MULTICENTER, RANDOMIZED, CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF APREMILAST IN EARLY PSORIATIC ARTHRITIS PATIENTS WITH OLIGOARTHRITIS AND MODERATE DISEASE ACTIVITY: APTITUDE (APremilasT In paTients With oligoarticUlar Psoriatic Arthritis DiseasE)
≥ 18 yrs), male or female subject
Disease duration since diagnosis ≥ 3 months and ≤ 24 months as based on the Classification Criteria for Psoriatic Arthritis (CASPAR),
SJC AND TJC must be >1 and ≤ 4
For all regions, the local Regulatory Label for treatment with apremilast must be followed.
Stable doses of protocol-allowed PsA medications
General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
Comply with protocol-required contraception measures
Prior use of >1 as DMARD.
Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
Use of intra-articular (IA) glucocorticoid injection within 8 weeks before the Baseline Visit.
Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
Prior use of cyclosporine.
Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Philip Mease, M.D.