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PIONEER I

Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

    Status Completed
    Related Conditions
    Hidradenitis Suppurativa

Enrollment Details

300 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Brief summary

Top

A study to evaluate the safety and efficacy of treatment in adults with moderate to severe hidradenitis suppurativa.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 5

0
Markham, ON
1
Quebec, QC
2
St. John's, NL
3
St. John's, NL
4
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

  • 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, Investigator)

  • 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

    • Adults must have a diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
    • HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
    • Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
    • Subject must have experienced an inadequate response to at least a 90 day treatment of oral antibiotics for treatment of HS.
    • Subject must have a count of greater than or equal to 3 at baseline.
    • Subject was previously treated with adalimumab or another anti-TNF therapy (e.g., infliximab or etanercept).
    • Subject received any oral antibiotic treatment for HS within 28 days prior to Baseline.
    • Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
    • If entering the study on concomitant oral analgesics for non-HS related pain:
      • Subject on opioid analgesics within 14 days prior to Baseline visit
      • Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).

More on this trial

Clinical Trials.gov