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Study Complete
Sponsor ID
CC-10004-PSA-013

Efficacy, safety, and tolerability study of apremilast to treat early oligoarticular psoriatic arthritis.FOREMOST

Sponsor ID
CC-10004-PSA-013
Clinicaltrials.gov ID
NCT03747939
EUCTIS ID
N/A
EudraCT ID
2018-002735-26
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
310
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects who achieved a clinical state of minimal disease activity defined MDA-Joints)

Timeframe: Week 16

Secondary Outcome Measures

Proportion of subjects with cDAPSA remission or low activity

Timeframe: Week 16

Proportion of subjects with SJC ≤ 1

Timeframe: Week 16

Proportion of subjects with TJC ≤ 1

Timeframe: Week 16

Proportion of subjects with improvement in the PsAID-12 score

Timeframe: Week 16

Proportion of subjects with improvement in the PASDAS score

Timeframe: Week 16

Proportion of subjects with improvement in the Patient Global Assessment of Disease Activity

Timeframe: Week 16

Proportion of subjects with improvement in the Patient Global Assessment Pain

Timeframe: Week 16

Study Documents

Plain Language Summary of Results
Available Language(s): German (Austria), Dutch (Belgium), French (Belgium), English (Canada), French (Canadian), English, French, German, English (UK), Italian, Russian, Spanish
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Locations

Location
Status
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Location
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany, 61231
Status
Completed
Location
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy, 25123
Status
Completed
Location
Hopital Erasme
Bruxelles, Belgium, 1070
Status
Completed
Location
Klein and Associates MD, PA - Cumberland
Cumberland, MD, United States, 21502
Status
Completed
Location
Altoona Center for Clinical Research
Duncansville, PA, United States, 16635
Status
Completed
Location
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, 40225
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Dec 2018 - Dec 2022
    Inclusion and Exclusion 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).