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ClinicalTrial.gov Identifier : NCT01251614

A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate

    Status Completed
    Related Conditions

Enrollment Details

114 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Brief summary

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This study will compare how well adalimumab works versus methotrexate (MTX) in children with moderate to severe psoriasis in the short term. It will also study how safe and how well adalimumab works in the long term and how long disease response can be maintained after stopping therapy.

Participant Attributes :
  • Male and Female
  • Ages 4 Years to 17 Years

Canada: 9

0
Calgary, AB
1
Montreal, QC
2
Quebec, QC
3
Vancouver, BC
4
Waterloo, ON
5
Markham, ON
6
Saskatoon, SK
7
St. John's, NL
8
Winnipeg, MB
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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.
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    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.
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    Endpoint Classification

    Safety/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.
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    Intervention Model

    Parallel Assignment

  • 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.
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    Purpose

    Treatment

    • Subject is ≥ 4 years and < 18 years of age
    • Subject weighs ≥ 13 kg
    • Subject must have failed to respond to topical therapy
    • Subject must need systemic treatment to control his/her disease and meet one of the following:
      • Physician's Global Assessment (PGA) ≥ 4
      • Body surface area (BSA) involved > 20%
      • Very thick lesions with BSA > 10% - Psoriasis Area and Severity Index (PASI) > 20
      • PASI > 10 and at least one of the following:
        • Active psoriatic arthritis unresponsive to non-steroid anti-inflammatory drugs (NSAIDs)
        • Clinically relevant facial involvement
        • Clinically relevant genital involvement * Clinically relevant hand and/or foot involvement
        • Children's Dermatology Life Quality Index (CDLQI) > 10
    • If subject is < 12 years of age and resides in a geographic region where heliotherapy is practical, subject must have failed to respond, be intolerant, or have a contraindication to heliotherapy, or is not a suitable candidate for heliotherapy
    • If ≥12 years of age, subject must have failed to respond, be intolerant, or have a contraindication to phototherapy, or is not a suitable candidate for phototherapy
    • Subject must have a clinical diagnosis of psoriasis for at least 6 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator
    • Subject must have stable plaque psoriasis for at least 2 months prior to Baseline
    • Prior biologic use other than prior treatment with etanercept
    • Treatment with etanercept therapy within 4 weeks prior to the Baseline visit
    • Methotrexate (MTX) use within the past year or prior MTX use at any time where the subject did not respond, or did not tolerate MTX
    • Contraindication for treatment with MTX during the study
    • Erythrodermic Ps, generalized or localized pustular Ps, medication-induced or medication exacerbated Ps or new onset guttate Ps
    • Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit
    • Treatment of Ps with topical therapies such as corticosteroids, vitamin D analogs, or retinoids within 7 days prior to the Baseline visit
    • Treatment of Ps with UVB phototherapy, excessive sun exposure, or the use of tanning beds within 7 days prior to the Baseline visit
    • Treatment of Ps with PUVA phototherapy, non-biologic systemic therapies for the treatment of Ps, or systemic therapies known to improve Ps within 14 days prior to the Baseline visit

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