Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Apremilast (CC-10004); Apremilast (CC-10004) Placebo
Intervention description: Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles.; Subjects randomized to placebo will receive "dummy" dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oligoarthritis; PsA; Apremilast; Oral tablet; Background therapy; Standard of care

Summary:

      This clinical study will test the effects of a drug called apremilast in oligoarticular
      psoriatic arthritis with less than 5 years of disease duration. In previous studies,
      apremilast has been shown to be safe and efficacious in reducing signs and symptoms of
      psoriatic arthritis, as well as improving physical function. This study will compare the
      effects of apremilast to placebo on psoriatic arthritis subjects in which the number of
      affected joints is limited (greater than 1 but less or equal to 4). About 285 patients
      worldwide will take part in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 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

        Exclusion Criteria:

          -  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).