Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 18 yrs, male or female subject
Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
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
Subject meets the Classification Criteria for Psoriatic Arthritis \[CASPAR\] Criteria for PsA at the Screening visit
You may not be if
Prior use of \>2 csDMARD to treat PsA
Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
Use of intra-articular (IA) or intra-muscular (IM) 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).
Clareo Health | Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
