Psoriasis Clinical Trial
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Summary
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
Eligibility Criteria
Inclusion Criteria:
PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
Not in MDA at the time of screening
Has 3 or more tender and 3 or more swollen joints
Treated with methotrexate 15 mg (weekly) for at least 4 weeks
Exclusion Criteria:
Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
History of methotrexate intolerance/toxicity
Medical conditions(s) precluding methotrexate dose increase above 15 mg
Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general
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There are 58 Locations for this study
Sun City Arizona, 85351, United States
Miami Florida, 33126, United States
Vernon Hills Illinois, 60061, United States
Baton Rouge Louisiana, 70836, United States
Worcester Massachusetts, 01605, United States
Saint Clair Shores Michigan, 48081, United States
New Bern North Carolina, 28562, United States
Wilmington North Carolina, 28401, United States
Duncansville Pennsylvania, 16635, United States
Dallas Texas, 75231, United States
Seattle Washington, 98104, United States
South Charleston West Virginia, 25309, United States
Camperdown New South Wales, 2050, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Paramatta New South Wales, 2150, Australia
Melbourne Victoria, 3128, Australia
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Santo André Sao Paulo, 09060, Brazil
Plovdiv , 4000, Bulgaria
Sofia , 1505, Bulgaria
Edmonton Alberta, T5M 0, Canada
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3A 1, Canada
St. John's Newfoundland and Labrador, A1C 5, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8N 1, Canada
Rimouski Quebec, G5L 8, Canada
Sainte-foy Quebec, G1V 3, Canada
Bogota Cundinamarca, 11022, Colombia
Bogota , 11112, Colombia
Medellin , 05003, Colombia
Jihlava 1 Jihlava, 586 0, Czechia
Prague 4 Praha 4, 140 0, Czechia
Heidelberg Baden-Wuerttemberg, 69120, Germany
Bruchhausen-Vilsen Niedersachsen, 27305, Germany
Kiel Schleswig-Holstein, 24105, Germany
Frankfurt , 60590, Germany
Hamburg , 22391, Germany
Catanzaro Calabria, 88100, Italy
Rome , 00161, Italy
Siena , 53100, Italy
Grodzisk Mazowiecki Mazowieckie, 05-82, Poland
Warsaw Mazowieckie, 01-51, Poland
Stalowa Wola Podkarpackie, 37-45, Poland
Bialystok , 15-87, Poland
Carolina , 00983, Puerto Rico
San Juan , 00917, Puerto Rico
Doha Ad Dawhah, , Qatar
Sabadell Barcelona, 08208, Spain
Badalona , 08916, Spain
Cordoba , 14004, Spain
Manises , 46940, Spain
Santa Cruz de Tenerife , 38320, Spain
Viladecans , 8840, Spain
Bath , BA1 1, United Kingdom
Edinburgh , EH4 2, United Kingdom
Londonderry , BT47 , United Kingdom
Manchester , M13 9, United Kingdom
Preston , BT47 , United Kingdom
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