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ClinicalTrial.gov Identifier : NCT01166282

A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis.

    Status Completed
    Related Conditions

Enrollment Details

46 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M11-328

Brief summary

Top

The study will evaluate how well adalimumab works and how safe it is in the treatment of children with Enthesitis Related Arthritis

Participant Attributes :
  • Male and Female
  • Ages 6 Years to 17 Years

Canada: 1

0
Toronto, ON
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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

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

    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

  • 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

    • Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR);
    • Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
    • Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.

     

    • Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;
    • Psoriasis or a history of psoriasis in the patient or first-degree relative;
    • Presence of Immunoglobulin M (IgM) rheumatoid factor; Presence of systemic JIA,
    • History of inflammatory bowel disease, previous biologic therapy including anti-TNF therapy with a potential impact on pediatric ERA;
    • Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline

More on this trial

Clinical Trials.gov