Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis. (FOREMOST)

  • End date
    Aug 7, 2023
  • participants needed
  • sponsor
Updated on 25 March 2022


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.

Condition Arthritis, Psoriatic
Treatment Apremilast (CC-10004), Apremilast (CC-10004) Placebo
Clinical Study IdentifierNCT03747939
Last Modified on25 March 2022


Yes No Not Sure

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 exposure to a JAK-inhibitor and/or a biologic DMARD
Prior use of >2 csDMARD to treat PsA
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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