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



Status:Recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:August 5, 2016
End Date:March 20, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country
study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed to
compare the achievement of minimal disease activity (MDA) between subjects randomized to
either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the
highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement
of MDA on four different treatment regimens using adalimumab and/or MTX, with subject
allocation based on the initial randomized treatment and achievement of MDA in Part 1, and
with rescue treatment option.


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
We found this trial at
13
sites
1020 Medical Park Avenue
New Bern, North Carolina 28562
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New Bern, NC
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Camperdown, New South Wales
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Camperdown,
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Miami, FL
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New Orleans, Louisiana 70121
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New Orleans, LA
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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Saint Clair Shores, MI
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Seattle, Washington 98104
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Seattle, WA
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South Charleston, West Virginia 25309
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South Charleston, WV
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Sun City, AZ
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565 Lakeview Parkway
Vernon Hills, Illinois 60061
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Vernon Hills, IL
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1907 Tradd Court
Wilmington, North Carolina 28401
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Wilmington, NC
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Worcester, Massachusetts 01605
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Worcester, MA
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