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

  • STATUS
    Recruiting
  • End date
    Aug 5, 2022
  • participants needed
    330
  • sponsor
    Amgen
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Updated on 17 February 2021
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apremilast

Summary

This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 2 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 330 patients worldwide will take part in this study.

Details
Condition PSORIATIC ARTHRITIS
Treatment Apremilast (CC-10004), Apremilast (CC-10004) Placebo
Clinical Study IdentifierNCT03747939
SponsorAmgen
Last Modified on17 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have PSORIATIC ARTHRITIS?
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
Do you have any of these conditions: Do you have PSORIATIC ARTHRITIS??
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)
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