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

Amgen

Status and phase: Completed; Phase 4

Conditions: Arthritis, Psoriatic

Treatments: Drug: Apremilast (CC-10004); Other: Apremilast (CC-10004) Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03747939

U1111-1224-0216 (Registry Identifier)

2018-002735-26 (EudraCT Number)

CC-10004-PSA-013

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

310 participants in 2 patient groups, including a placebo group

Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD

Experimental group

Description:

Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications

Treatment:

Drug: Apremilast (CC-10004)

Placebo

Placebo Comparator group

Description:

Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.

Treatment:

Other: Apremilast (CC-10004) Placebo