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A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

NCT ID: NCT02814175

Last Updated: 2020-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-05

Study Completion Date

2020-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis

Keywords

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: MTX Escalated Dose

Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)

Group Type ACTIVE_COMPARATOR

methotrexate (MTX)

Intervention Type DRUG

Part 1: ADA + MTX

Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew

Group Type EXPERIMENTAL

methotrexate (MTX)

Intervention Type DRUG

adalimumab (ADA)

Intervention Type BIOLOGICAL

Part 2: MTX Escalated Dose

Participants 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

Group Type ACTIVE_COMPARATOR

methotrexate (MTX)

Intervention Type DRUG

Part 2: ADA + MTX Escalated Dose

Participants 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

Group Type ACTIVE_COMPARATOR

methotrexate (MTX)

Intervention Type DRUG

adalimumab (ADA)

Intervention Type BIOLOGICAL

Part 2: ADA

Participants 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

Group Type EXPERIMENTAL

adalimumab (ADA)

Intervention Type BIOLOGICAL

Part 2: ADA ew + MTX

Participants 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

Group Type EXPERIMENTAL

methotrexate (MTX)

Intervention Type DRUG

adalimumab (ADA)

Intervention Type BIOLOGICAL

Interventions

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methotrexate (MTX)

Intervention Type DRUG

adalimumab (ADA)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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AZ Arthritis & Rheum Research /ID# 161796

Sun City, Arizona, United States

Site Status

LeJenue Research Associates /ID# 200093

Miami, Florida, United States

Site Status

Deerbrook Medical Associates /ID# 158655

Vernon Hills, Illinois, United States

Site Status

Ochsner Clinic Foundation /ID# 155178

Baton Rouge, Louisiana, United States

Site Status

Clinical Pharmacology Study Gr /ID# 161057

Worcester, Massachusetts, United States

Site Status

Shores Rheumatology, PC /ID# 162697

Saint Clair Shores, Michigan, United States

Site Status

Coastal Carolina Health Care /ID# 152088

New Bern, North Carolina, United States

Site Status

PMG Research of Wilmington LLC /ID# 152089

Wilmington, North Carolina, United States

Site Status

Altoona Ctr Clinical Res /ID# 152087

Duncansville, Pennsylvania, United States

Site Status

Metroplex Clinical Research /ID# 162486

Dallas, Texas, United States

Site Status

Swedish Medical Center /ID# 162051

Seattle, Washington, United States

Site Status

West Virginia Research Inst /ID# 157815

South Charleston, West Virginia, United States

Site Status

Royal Prince Alfred Hospital /ID# 153144

Camperdown, New South Wales, Australia

Site Status

Optimus Clinical Research Pty. /ID# 153145

Kogarah, New South Wales, Australia

Site Status

Liverpool Hospital /ID# 153147

Liverpool, New South Wales, Australia

Site Status

BJC Health /ID# 153875

Paramatta, New South Wales, Australia

Site Status

Box Hill Hospital /ID# 153146

Melbourne, Victoria, Australia

Site Status

Hospital de Clinicas de Porto Alegre /ID# 152345

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Faculdade de Medicina do ABC /ID# 152344

Santo André, São Paulo, Brazil

Site Status

MHAT Trimontsium /ID# 152658

Plovdiv, , Bulgaria

Site Status

Diag Consult Ctr 17 Sofia EOOD /ID# 152657

Sofia, , Bulgaria

Site Status

Rheumatology Research Assoc /ID# 161600

Edmonton, Alberta, Canada

Site Status

Percuro Clinical Research, Ltd /ID# 161601

Victoria, British Columbia, Canada

Site Status

Manitoba Clinic /ID# 151939

Winnipeg, Manitoba, Canada

Site Status

St. Clare's Mercy Hospital /ID# 159680

St. John's, Newfoundland and Labrador, Canada

Site Status

The Waterside Clinic /ID# 151938

Barrie, Ontario, Canada

Site Status

Adachi Medicine Prof. Corp /ID# 152575

Hamilton, Ontario, Canada

Site Status

Ctr. de Rheum de l'est du QC /ID# 151937

Rimouski, Quebec, Canada

Site Status

Groupe de Recherche en Maladies Osseuses /ID# 205693

Sainte-Foy, Quebec, Canada

Site Status

Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954

Bogota, Cundinamarca, Colombia

Site Status

Riesgo de Fractura S.A - CAYRE /ID# 153817

Bogotá, , Colombia

Site Status

San Vicente Fundacion /Id# 171324

Medellín, , Colombia

Site Status

Revmatolog s.r.o. /ID# 151753

Jihlava, Jihlava, Czechia

Site Status

Nuselská poliklinika, Revmatologie /ID# 151754

Prague, Praha 4, Czechia

Site Status

Universitaetsklinik Heidelberg /ID# 152229

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982

Bruchhausen-Vilsen, Lower Saxony, Germany

Site Status

Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 152231

Kiel, Schleswig-Holstein, Germany

Site Status

CIRI GmbH /ID# 152228

Frankfurt, , Germany

Site Status

Hamburger Rheuma I /ID# 164055

Hamburg, , Germany

Site Status

Universita di Catanzaro Magna Graecia /ID# 152013

Catanzaro, Calabria, Italy

Site Status

Azienda Ospedaliera Policlinic /ID# 152011

Rome, , Italy

Site Status

A.O. Universitaria Senese /ID# 152012

Siena, , Italy

Site Status

McBk Sc /Id# 163089

Grodzisk Mazowiecki, Masovian Voivodeship, Poland

Site Status

Centrum Medyczne AMED /ID# 164047

Warsaw, Masovian Voivodeship, Poland

Site Status

SANUS Szpital Specjalistyczny /ID# 151988

Stalowa Wola, Podkarpackie Voivodeship, Poland

Site Status

ClinicMed Badurski i wspolnicy SJ /ID# 151987

Bialystok, , Poland

Site Status

Dr. Ramon L. Ortega-Colon, MD /ID# 152957

Carolina, , Puerto Rico

Site Status

GCM Medical Group, PSC /ID# 152091

San Juan, , Puerto Rico

Site Status

Hamad Hospital /ID# 152334

Doha, Baladīyat ad Dawḩah, Qatar

Site Status

Corporac Sanitaria Parc Tauli /ID# 151759

Sabadell, Barcelona, Spain

Site Status

Hospital Univ Germans Trias I Pujol /ID# 151760

Badalona, , Spain

Site Status

Hospital Universitario Reina S /ID# 151761

Córdoba, , Spain

Site Status

Hospital Manises /ID# 162778

Manises, , Spain

Site Status

Hospital Univ Canarias /ID# 206489

Santa Cruz de Tenerife, , Spain

Site Status

Hospital de Viladecans /ID# 163875

Viladecans, , Spain

Site Status

Royal National Hosp for Rheuma /ID# 152767

Bath, , United Kingdom

Site Status

Western General Hospital /ID# 155195

Edinburgh, , United Kingdom

Site Status

Altnagelvin Area Hospital /ID# 152766

Londonderry, , United Kingdom

Site Status

Central Manchester University /ID# 152765

Manchester, , United Kingdom

Site Status

Lancashire Care NHS Foundation /ID# 152769

Preston, , United Kingdom

Site Status

Countries

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United States Australia Brazil Bulgaria Canada Colombia Czechia Germany Italy Poland Puerto Rico Qatar Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38288922 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-000191-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-496

Identifier Type: -

Identifier Source: org_study_id