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

Study Identifier
M14-496
CT.gov Identifier
NCT02814175
EudraCT Identifier
2016-000191-21
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, Bulgarian, Czech, Polish, Portuguese (Brazil), Spanish
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Psoriatic Arthritis (PsA)
    • Study Drug
  • methotrexate (MTX)
  • adalimumab (ADA)
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    AZ Arthritis & Rheum Research /ID# 161796
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    LeJenue Research Associates /ID# 200093
    Miami, Florida, United States, 33126
    Status
    Not applicable
    Location
    Deerbrook Medical Associates /ID# 158655
    Vernon Hills, Illinois, United States, 60061
    Status
    Not applicable
    Location
    Ochsner Clinic Foundation /ID# 155178
    Baton Rouge, Louisiana, United States, 70836-6455
    Status
    Not applicable
    Location
    Clinical Pharmacology Study Gr /ID# 161057
    Worcester, Massachusetts, United States, 01605
    Status
    Not applicable
    Location
    Shores Rheumatology, PC /ID# 162697
    Saint Clair Shores, Michigan, United States, 48081
    Status
    Not applicable
    Showing {first} - {last} of {total} Results