Psoriasis Clinical Trial
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Summary
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.
Eligibility 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).
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There are 112 Locations for this study
Mesa Arizona, 85202, United States
Covina California, 91722, United States
Encino California, 91436, United States
Fullerton California, 92835, United States
San Diego California, 92128, United States
San Leandro California, 94578, United States
Thousand Oaks California, 91360, United States
Tustin California, 92780, United States
Upland California, 91786, United States
Denver Colorado, 80230, United States
Aventura Florida, 33180, United States
Clearwater Florida, 33765, United States
Fort Lauderdale Florida, 33309, United States
Gainesville Florida, 32610, United States
Plantation Florida, 33324, United States
Saint Augustine Florida, 32080, United States
Tampa Florida, 33606, United States
Tampa Florida, 33612, United States
Tampa Florida, 33614, United States
Lawrenceville Georgia, 30046, United States
Hinsdale Illinois, 60521, United States
Rockford Illinois, 61114, United States
Bowling Green Kentucky, 42101, United States
Metairie Louisiana, 70006, United States
Cumberland Maryland, 21502, United States
Hagerstown Maryland, 21740, United States
Worcester Massachusetts, 01605, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48910, United States
Saint Clair Shores Michigan, 48081, United States
Eagan Minnesota, 55121, United States
Voorhees New Jersey, 08043, United States
New York New York, 10003, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44106, United States
Middleburg Heights Ohio, 44130, United States
Middletown Ohio, 45044, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Philadelphia Pennsylvania, 19152, United States
Providence Rhode Island, 02903, United States
Greenville South Carolina, 29601, United States
Jackson Tennessee, 38305, United States
Baytown Texas, 77521, United States
Colleyville Texas, 76034, United States
El Paso Texas, 79902, United States
Lubbock Texas, 79410, United States
The Woodlands Texas, 77382, United States
Webster Texas, 92103, United States
Seattle Washington, 98104, United States
Beckley West Virginia, 25801, United States
South Charleston West Virginia, 25309, United States
Vienna , 1090, Austria
Vienna , 1130, Austria
Bruxelles , 1020, Belgium
Bruxelles , 1070, Belgium
Leuven , 3000, Belgium
Merksem , 2170, Belgium
Winnipeg Manitoba, R3A 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5T 2, Canada
Windsor Ontario, N8X 1, Canada
Montreal Quebec, H2L 1, Canada
Orleans cedex 2 , 45067, France
Paris , 75010, France
Paris , 75013, France
Toulouse cedex 9 , 31059, France
Amberg , 92224, Germany
Bad Nauheim , 61231, Germany
Berlin , 10117, Germany
Duesseldorf , 40225, Germany
Erfurt , 99096, Germany
Frankfurt am Main , 60590, Germany
Freiburg , 79106, Germany
Herne , 44649, Germany
Tuebingen , 72076, Germany
Bari , 70124, Italy
Brescia , 25123, Italy
Messina , 98125, Italy
Milano , 20132, Italy
Napoli , 80131, Italy
Pavia 2 , 27100, Italy
Pisa , 56126, Italy
Rome , 00133, Italy
Rozzano MI , 20089, Italy
Verona , 37126, Italy
Enschede , 7512 , Netherlands
Rotterdam , 3015 , Netherlands
Kazan , 42009, Russian Federation
Kursk , 30500, Russian Federation
Moscow , 11552, Russian Federation
Moscow , 12911, Russian Federation
Novosibirsk , 63006, Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov-on-don , 34402, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint-Petersburg , 19101, Russian Federation
Tomsk , 63406, Russian Federation
Baracaldo País Vasco, 48903, Spain
Galdakao , 48960, Spain
Gran Canaria , 35016, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Merida , 06800, Spain
Derby , DE1 2, United Kingdom
Eastbourne , BN21 , United Kingdom
Edinburgh Scotland , EH4 2, United Kingdom
London , SE5 9, United Kingdom
Luton , LU4 0, United Kingdom
Torquay South Devon , TQ12 , United Kingdom
Truro , TR1 3, United Kingdom
Wolverhampton , WV10 , United Kingdom
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