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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

246

Study ID:

NCT02814175

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 58 Locations for this study

See Locations Near You

AZ Arthritis & Rheum Research /ID# 161796
Sun City Arizona, 85351, United States
LeJenue Research Associates /ID# 200093
Miami Florida, 33126, United States
Deerbrook Medical Associates /ID# 158655
Vernon Hills Illinois, 60061, United States
Ochsner Clinic Foundation /ID# 155178
Baton Rouge Louisiana, 70836, United States
Clinical Pharmacology Study Gr /ID# 161057
Worcester Massachusetts, 01605, United States
Shores Rheumatology, PC /ID# 162697
Saint Clair Shores Michigan, 48081, United States
Coastal Carolina Health Care /ID# 152088
New Bern North Carolina, 28562, United States
PMG Research of Wilmington LLC /ID# 152089
Wilmington North Carolina, 28401, United States
Altoona Ctr Clinical Res /ID# 152087
Duncansville Pennsylvania, 16635, United States
Metroplex Clinical Research /ID# 162486
Dallas Texas, 75231, United States
Swedish Medical Center /ID# 162051
Seattle Washington, 98104, United States
West Virginia Research Inst /ID# 157815
South Charleston West Virginia, 25309, United States
Royal Prince Alfred Hospital /ID# 153144
Camperdown New South Wales, 2050, Australia
Optimus Clinical Research Pty. /ID# 153145
Kogarah New South Wales, 2217, Australia
Liverpool Hospital /ID# 153147
Liverpool New South Wales, 2170, Australia
BJC Health /ID# 153875
Paramatta New South Wales, 2150, Australia
Box Hill Hospital /ID# 153146
Melbourne Victoria, 3128, Australia
Hospital de Clinicas de Porto Alegre /ID# 152345
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Faculdade de Medicina do ABC /ID# 152344
Santo André Sao Paulo, 09060, Brazil
MHAT Trimontsium /ID# 152658
Plovdiv , 4000, Bulgaria
Diag Consult Ctr 17 Sofia EOOD /ID# 152657
Sofia , 1505, Bulgaria
Rheumatology Research Assoc /ID# 161600
Edmonton Alberta, T5M 0, Canada
Percuro Clinical Research, Ltd /ID# 161601
Victoria British Columbia, V8V 3, Canada
Manitoba Clinic /ID# 151939
Winnipeg Manitoba, R3A 1, Canada
St. Clare's Mercy Hospital /ID# 159680
St. John's Newfoundland and Labrador, A1C 5, Canada
The Waterside Clinic /ID# 151938
Barrie Ontario, L4M 6, Canada
Adachi Medicine Prof. Corp /ID# 152575
Hamilton Ontario, L8N 1, Canada
Ctr. de Rheum de l'est du QC /ID# 151937
Rimouski Quebec, G5L 8, Canada
Groupe de Recherche en Maladies Osseuses /ID# 205693
Sainte-foy Quebec, G1V 3, Canada
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954
Bogota Cundinamarca, 11022, Colombia
Riesgo de Fractura S.A - CAYRE /ID# 153817
Bogota , 11112, Colombia
San Vicente Fundacion /Id# 171324
Medellin , 05003, Colombia
Revmatolog s.r.o. /ID# 151753
Jihlava 1 Jihlava, 586 0, Czechia
Nuselská poliklinika, Revmatologie /ID# 151754
Prague 4 Praha 4, 140 0, Czechia
Universitaetsklinik Heidelberg /ID# 152229
Heidelberg Baden-Wuerttemberg, 69120, Germany
Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982
Bruchhausen-Vilsen Niedersachsen, 27305, Germany
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 152231
Kiel Schleswig-Holstein, 24105, Germany
CIRI GmbH /ID# 152228
Frankfurt , 60590, Germany
Hamburger Rheuma I /ID# 164055
Hamburg , 22391, Germany
Universita di Catanzaro Magna Graecia /ID# 152013
Catanzaro Calabria, 88100, Italy
Azienda Ospedaliera Policlinic /ID# 152011
Rome , 00161, Italy
A.O. Universitaria Senese /ID# 152012
Siena , 53100, Italy
McBk Sc /Id# 163089
Grodzisk Mazowiecki Mazowieckie, 05-82, Poland
Centrum Medyczne AMED /ID# 164047
Warsaw Mazowieckie, 01-51, Poland
SANUS Szpital Specjalistyczny /ID# 151988
Stalowa Wola Podkarpackie, 37-45, Poland
ClinicMed Badurski i wspolnicy SJ /ID# 151987
Bialystok , 15-87, Poland
Dr. Ramon L. Ortega-Colon, MD /ID# 152957
Carolina , 00983, Puerto Rico
GCM Medical Group, PSC /ID# 152091
San Juan , 00917, Puerto Rico
Hamad Hospital /ID# 152334
Doha Ad Dawhah, , Qatar
Corporac Sanitaria Parc Tauli /ID# 151759
Sabadell Barcelona, 08208, Spain
Hospital Univ Germans Trias I Pujol /ID# 151760
Badalona , 08916, Spain
Hospital Universitario Reina S /ID# 151761
Cordoba , 14004, Spain
Hospital Manises /ID# 162778
Manises , 46940, Spain
Hospital Univ Canarias /ID# 206489
Santa Cruz de Tenerife , 38320, Spain
Hospital de Viladecans /ID# 163875
Viladecans , 8840, Spain
Royal National Hosp for Rheuma /ID# 152767
Bath , BA1 1, United Kingdom
Western General Hospital /ID# 155195
Edinburgh , EH4 2, United Kingdom
Altnagelvin Area Hospital /ID# 152766
Londonderry , BT47 , United Kingdom
Central Manchester University /ID# 152765
Manchester , M13 9, United Kingdom
Lancashire Care NHS Foundation /ID# 152769
Preston , BT47 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

246

Study ID:

NCT02814175

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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