CONTROL
Brief summary
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 an active drug 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 an active drug and/or MTX, with subject allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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
