A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of an Active Drug Introduction Compared With Methotrexate Dose Escalation (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

Psoriatic Arthritis
246 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
None (Open Label)


Eligibility criteria

Participant attributes:
Male and Female


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

All the cities where the clinical studies are located

Edmonton - T5M 0H4
Victoria - V8V 3M9
St. John's - A1C 5B8
Barrie - L4M 6L2
Hamilton - L8N 1Y2
Rimouski - G5L 8W1
Sainte-foy - G1V 3M7
Winnipeg - R3A 1M3


British Columbia


Newfoundland and Labrador

More information about this study