Last updated on May 2020

Efficacy Safety and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior use of >1 as DMARD.
  • 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).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.