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

Completed · Phase 4 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT03747939

Run by

Amgen

People needed

310

Starts

2018-12-31

Expected to finish

2023-07-05

Last updated by the study team

2024-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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).

Where it is running

• Covina Arthritis Clinic — Covina, California, United States
• Encino Research Center — Encino, California, United States
• Providence Medical Foundation — Fullerton, California, United States
• Rheumatology Center of San Diego PC — San Diego, California, United States
• East Bay Rheumatology Medical — San Leandro, California, United States
• Millennium Clinical Trials — Thousand Oaks, California, United States
• Robin K Dore MD Inc — Tustin, California, United States
• Inland Rheumatology Clinical Trials Inc — Upland, California, United States
• Denver Arthritis Clinic PC — Denver, Colorado, United States
• Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
• Clinical Research of West Florida, Inc — Clearwater, Florida, United States
• Center for Rheumatology, Immunology, and Arthritis — Fort Lauderdale, Florida, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Integral Rheumatology and Immunology Specialists — Plantation, Florida, United States
• Florida Center For Dermatology — Saint Augustine, Florida, United States
• Clinical Research of West Florida Inc — Tampa, Florida, United States
• Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida, United States
• Baycare Medical Group Inc — Tampa, Florida, United States
• North Georgia Rheumatology Group PC — Lawrenceville, Georgia, United States
• RC Rsearch Inc — Hinsdale, Illinois, United States
• OrthoIllinois — Rockford, Illinois, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Clinical Trials Management LLC — Metairie, Louisiana, United States
• Klein and Associates MD, PA - Cumberland — Cumberland, Maryland, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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