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CONTROL

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

    Status Recruiting
    Related Conditions
    Psoriatic Arthritis

Enrollment Details

240 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type IV phase trial.

Protocol ID
M14-496

Brief summary

Top

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.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 8

0
Edmonton, AB
1
Victoria, BC
2
Winnipeg, MB
3
St. John's, NL
4
Barrie, ON
5
Hamilton, ON
6
Rimouski, QC
7
Sainte-Foy, QC
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
    ?

    Endpoint Classification

    Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
    ?

    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
    ?

    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    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
    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

More on this trial

Clinical Trials.gov