A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Completed · Phase 4
Conditions studied: Psoriatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT02814175
- Run by
- AbbVie
- People needed
- 246
- Starts
- 2016-08-05
- Expected to finish
- 2020-03-19
- Last updated by the study team
- 2020-11-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- LeJenue Research Associates /ID# 200093 — Miami, Florida, United States
- Deerbrook Medical Associates /ID# 158655 — Vernon Hills, Illinois, United States
- Ochsner Clinic Foundation /ID# 155178 — Baton Rouge, Louisiana, United States
- Clinical Pharmacology Study Gr /ID# 161057 — Worcester, Massachusetts, United States
- Shores Rheumatology, PC /ID# 162697 — Saint Clair Shores, Michigan, United States
- Coastal Carolina Health Care /ID# 152088 — New Bern, North Carolina, United States
- PMG Research of Wilmington LLC /ID# 152089 — Wilmington, North Carolina, United States
- Altoona Ctr Clinical Res /ID# 152087 — Duncansville, Pennsylvania, United States
- Metroplex Clinical Research /ID# 162486 — Dallas, Texas, United States
- Swedish Medical Center /ID# 162051 — Seattle, Washington, United States
- West Virginia Research Inst /ID# 157815 — South Charleston, West Virginia, United States
- Royal Prince Alfred Hospital /ID# 153144 — Camperdown, New South Wales, Australia
- Optimus Clinical Research Pty. /ID# 153145 — Kogarah, New South Wales, Australia
- Liverpool Hospital /ID# 153147 — Liverpool, New South Wales, Australia
- BJC Health /ID# 153875 — Parramatta, New South Wales, Australia
- Box Hill Hospital /ID# 153146 — Melbourne, Victoria, Australia
- Hospital de Clinicas de Porto Alegre /ID# 152345 — Porto Alegre, Rio Grande do Sul, Brazil
- Faculdade de Medicina do ABC /ID# 152344 — Santo André, São Paulo, Brazil
- MHAT Trimontsium /ID# 152658 — Plovdiv, Bulgaria
- Diag Consult Ctr 17 Sofia EOOD /ID# 152657 — Sofia, Bulgaria
- Rheumatology Research Assoc /ID# 161600 — Edmonton, Alberta, Canada
- Percuro Clinical Research, Ltd /ID# 161601 — Victoria, British Columbia, Canada
- Manitoba Clinic /ID# 151939 — Winnipeg, Manitoba, Canada
- St. Clare's Mercy Hospital /ID# 159680 — St. John's, Newfoundland and Labrador, Canada
- AZ Arthritis & Rheum Research /ID# 161796 — Sun City, Arizona, United States
Full record on ClinicalTrials.gov
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