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 |
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.
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
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1020 Medical Park Avenue
New Bern, North Carolina 28562
New Bern, North Carolina 28562
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