A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
CONTROL
A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)
2 other identifiers
interventional
246
14 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2016
Longer than P75 for phase_4
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2020
CompletedResults Posted
Study results publicly available
November 23, 2020
CompletedNovember 23, 2020
October 1, 2020
3.1 years
June 21, 2016
September 15, 2020
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).
Week 16
Secondary Outcomes (12)
Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)
From Day 1 to Week 16
Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)
From Day 1 to Week 16
Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)
From Day 1 to Week 16
Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)
From Day 1 to Week 16
Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)
Week 16
- +7 more secondary outcomes
Study Arms (6)
Part 1: MTX Escalated Dose
ACTIVE COMPARATORMethotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Part 1: ADA + MTX
EXPERIMENTALAdalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Part 2: MTX Escalated Dose
ACTIVE COMPARATORParticipants achieving minimal disease activity (MDA) at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose
Part 2: ADA + MTX Escalated Dose
ACTIVE COMPARATORParticipants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew
Part 2: ADA
EXPERIMENTALParticipants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
Part 2: ADA ew + MTX
EXPERIMENTALParticipants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (60)
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, 70836-6455, 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, 90035-903, Brazil
Faculdade de Medicina do ABC /ID# 152344
Santo André, São Paulo, 09060-870, 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 0H4, Canada
Percuro Clinical Research, Ltd /ID# 161601
Victoria, British Columbia, V8V 3M9, Canada
Manitoba Clinic /ID# 151939
Winnipeg, Manitoba, R3A 1M3, Canada
St. Clare's Mercy Hospital /ID# 159680
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
The Waterside Clinic /ID# 151938
Barrie, Ontario, L4M 6L2, Canada
Adachi Medicine Prof. Corp /ID# 152575
Hamilton, Ontario, L8N 1Y2, Canada
Ctr. de Rheum de l'est du QC /ID# 151937
Rimouski, Quebec, G5L 8W1, Canada
Groupe de Recherche en Maladies Osseuses /ID# 205693
Sainte-Foy, Quebec, G1V 3M7, Canada
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954
Bogota, Cundinamarca, 110221, Colombia
Riesgo de Fractura S.A - CAYRE /ID# 153817
Bogotá, 111121, Colombia
San Vicente Fundacion /Id# 171324
Medellín, 050034, Colombia
Revmatolog s.r.o. /ID# 151753
Jihlava, Jihlava, 586 01, Czechia
Nuselská poliklinika, Revmatologie /ID# 151754
Prague, Praha 4, 140 00, Czechia
Universitaetsklinik Heidelberg /ID# 152229
Heidelberg, Baden-Wurttemberg, 69120, Germany
Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982
Bruchhausen-Vilsen, Lower Saxony, 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, Masovian Voivodeship, 05-825, Poland
Centrum Medyczne AMED /ID# 164047
Warsaw, Masovian Voivodeship, 01-518, Poland
SANUS Szpital Specjalistyczny /ID# 151988
Stalowa Wola, Podkarpackie Voivodeship, 37-450, Poland
ClinicMed Badurski i wspolnicy SJ /ID# 151987
Bialystok, 15-879, 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, Baladīyat ad Dawḩah, 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
Córdoba, 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 1RL, United Kingdom
Western General Hospital /ID# 155195
Edinburgh, EH4 2XU, United Kingdom
Altnagelvin Area Hospital /ID# 152766
Londonderry, BT47 6SB, United Kingdom
Central Manchester University /ID# 152765
Manchester, M13 9WL, United Kingdom
Lancashire Care NHS Foundation /ID# 152769
Preston, BT47 3EN, United Kingdom
Related Publications (1)
Coates LC, Tillett W, D'Agostino MA, Rahman P, Behrens F, McDearmon-Blondell EL, Bu X, Chen L, Kapoor M, Conaghan PG, Mease P. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 Apr;4(4):e262-e273. doi: 10.1016/S2665-9913(22)00008-X. Epub 2022 Feb 25.
PMID: 38288922DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 27, 2016
Study Start
August 5, 2016
Primary Completion
September 23, 2019
Study Completion
March 19, 2020
Last Updated
November 23, 2020
Results First Posted
November 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.