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PIONEER (OLE)

Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

    Status Active, not recruiting
    Related Conditions
    Hidradenitis Suppurativa

Enrollment Details

510 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M12-555

Brief summary

Top

Hidradenitis Suppurativa is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This Study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria. The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe HS.

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

Canada: 11

0
Barrie, ON
1
Halifax, NS
2
Markham, ON
3
Moncton, NB
4
Peterborough, ON
5
Quebec City, QC
6
St. John's, NL
7
St. John's, NL
8
Surrey, BC
9
Waterloo, ON
10
Winnipeg, MB
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Study Design

  • 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

    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.
    ?

    Intervention Model

    Single Group Assignment

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

    • Subjects who previously participated in a prior Phase 3 Abbott HS study and:
      • Completed the study; or
      • Experienced a loss of response (LOR); or
      • Experienced Worsening or Absence of Improvement
    • Prior treatment with any other anti-TNF therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 Abbott HS study.
    • Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 Abbott HS study.
    • Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit, except for permitted analgesics taken in the prior Phase 3 Abbott HS study

More on this trial

Clinical Trials.gov