Clinical trial NCT02814175: A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Official title: A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
2. Not in MDA at the time of screening
3. Has 3 or more tender and 3 or more swollen joints
4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
2. History of methotrexate intolerance/toxicity
3. Medical conditions(s) precluding methotrexate dose increase above 15 mg
4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general

Primary outcomes:
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
timeFrame: Week 16
Secondary outcomes:
measure: Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)
timeFrame: Week 16
measure: Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline
timeFrame: From Day 1 to Week 16
measure: Percentage of Participants in MDA in Part 2 of the Study (Week 32)
timeFrame: Week 32
measure: Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)
timeFrame: From Day 1 to week 16
measure: Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Change in HAQ-DI Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1)
timeFrame: Week 16
measure: Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)
timeFrame: From Day 1 to Week 16
Other outcomes:
Locations:
city: Sun City
country: United States
facility: AZ Arthritis & Rheum Research /ID# 161796
state: Arizona
city: Miami
country: United States
facility: LeJenue Research Associates /ID# 200093
state: Florida
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates /ID# 158655
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation /ID# 155178
state: Louisiana
city: Worcester
country: United States
facility: Clinical Pharmacology Study Gr /ID# 161057
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology, PC /ID# 162697
state: Michigan
city: New Bern
country: United States
facility: Coastal Carolina Health Care /ID# 152088
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 152089
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 152087
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research /ID# 162486
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center /ID# 162051
state: Washington
city: South Charleston
country: United States
facility: West Virginia Research Inst /ID# 157815
state: West Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 153144
state: New South Wales
city: Kogarah
country: Australia
facility: Optimus Clinical Research Pty. /ID# 153145
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 153147
state: New South Wales
city: Paramatta
country: Australia
facility: BJC Health /ID# 153875
state: New South Wales
city: Melbourne
country: Australia
facility: Box Hill Hospital /ID# 153146
state: Victoria
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 152345
state: Rio Grande Do Sul
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC /ID# 152344
state: Sao Paulo
city: Plovdiv
country: Bulgaria
facility: MHAT Trimontsium /ID# 152658
city: Sofia
country: Bulgaria
facility: Diag Consult Ctr 17 Sofia EOOD /ID# 152657
city: Edmonton
country: Canada
facility: Rheumatology Research Assoc /ID# 161600
state: Alberta
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 161601
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 151939
state: Manitoba
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital /ID# 159680
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: The Waterside Clinic /ID# 151938
state: Ontario
city: Hamilton
country: Canada
facility: Adachi Medicine Prof. Corp /ID# 152575
state: Ontario
city: Rimouski
country: Canada
facility: Ctr. de Rheum de l'est du QC /ID# 151937
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses /ID# 205693
state: Quebec
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954
state: Cundinamarca
city: Bogota
country: Colombia
facility: Riesgo de Fractura S.A - CAYRE /ID# 153817
city: Medellin
country: Colombia
facility: San Vicente Fundacion /Id# 171324
city: Jihlava 1
country: Czechia
facility: Revmatolog s.r.o. /ID# 151753
state: Jihlava
city: Prague 4
country: Czechia
facility: Nuselská poliklinika, Revmatologie /ID# 151754
state: Praha 4
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 152229
state: Baden-Wuerttemberg
city: Bruchhausen-Vilsen
country: Germany
facility: Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982
state: Niedersachsen
city: Kiel
country: Germany
facility: Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 152231
state: Schleswig-Holstein
city: Frankfurt
country: Germany
facility: CIRI GmbH /ID# 152228
city: Hamburg
country: Germany
facility: Hamburger Rheuma I /ID# 164055
city: Catanzaro
country: Italy
facility: Universita di Catanzaro Magna Graecia /ID# 152013
state: Calabria
city: Rome
country: Italy
facility: Azienda Ospedaliera Policlinic /ID# 152011
city: Siena
country: Italy
facility: A.O. Universitaria Senese /ID# 152012
city: Grodzisk Mazowiecki
country: Poland
facility: McBk Sc /Id# 163089
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne AMED /ID# 164047
state: Mazowieckie
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny /ID# 151988
state: Podkarpackie
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy SJ /ID# 151987
city: Carolina
country: Puerto Rico
facility: Dr. Ramon L. Ortega-Colon, MD /ID# 152957
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC /ID# 152091
city: Doha
country: Qatar
facility: Hamad Hospital /ID# 152334
state: Ad Dawhah
city: Sabadell
country: Spain
facility: Corporac Sanitaria Parc Tauli /ID# 151759
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Univ Germans Trias I Pujol /ID# 151760
city: Cordoba
country: Spain
facility: Hospital Universitario Reina S /ID# 151761
city: Manises
country: Spain
facility: Hospital Manises /ID# 162778
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Univ Canarias /ID# 206489
city: Viladecans
country: Spain
facility: Hospital de Viladecans /ID# 163875
city: Bath
country: United Kingdom
facility: Royal National Hosp for Rheuma /ID# 152767
city: Edinburgh
country: United Kingdom
facility: Western General Hospital /ID# 155195
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital /ID# 152766
city: Manchester
country: United Kingdom
facility: Central Manchester University /ID# 152765
city: Preston
country: United Kingdom
facility: Lancashire Care NHS Foundation /ID# 152769
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: