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



Status:Recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 19, 2018
End Date:January 29, 2021
Contact:Judith Maccarone, BSN
Email:jmaccarone@celgene.com
Phone:908-897-04134

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A MULTICENTER, RANDOMIZED, CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF APREMILAST IN EARLY PSORIATIC ARTHRITIS PATIENTS WITH OLIGOARTHRITIS AND MODERATE DISEASE ACTIVITY: APTITUDE (APremilasT In paTients With oligoarticUlar Psoriatic Arthritis DiseasE)

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.


Inclusion Criteria:

- ≥ 18 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).
We found this trial at
28
sites
Worcester, Massachusetts 01610
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Charlotte, North Carolina 28204
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Charlotte, NC
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500 West San Bernardino Road
Covina, California 91722
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Cumberland, Maryland 21502
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
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Fort Lauderdale, Florida 33334
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3450 Hull Road
Gainesville, Florida 32610
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Hagerstown, Maryland 21740
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Jackson, Tennessee 38305
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Lansing, Michigan 48910
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500 Medical Center Boulevard
Lawrenceville, Georgia 30046
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Lubbock, Texas 79410
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New York, New York 10016
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Oklahoma City, Oklahoma 73103
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Philadelphia, Pennsylvania 19152
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Plantation, FL
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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Salt Lake City, Utah 84132
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San Leandro, California 94578
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Seattle, Washington 98104
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Stockerau,
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