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Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER (OLE))

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01635764
First received: March 2, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hidradenitis Suppurativa
 Biological: Adalimumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study Protocol M12-555 - PIONEER (Open-Label Extension) A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects achieving clinical response. [ Time Frame: Baseline (Week 0) up to Week 60. ] [ Designated as safety issue: No ]
    Subjects achieving improvement in hidradenitis suppurativa severity.


Estimated Enrollment: 540
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab Biological: Adalimumab
Prefilled syringe of adalimumab
Other Name: Humira

Detailed Description:

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe HS. The clinical trial identifier is PIONEER (OPEN-LABEL EXTENSION).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635764

  Show 72 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: David Williams, MD AbbVie
  More Information

Additional Information:
United States Prescribing Information is provided. Important Note: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01635764     History of Changes
Other Study ID Numbers: M12-555, 2011-003478-98
Study First Received: March 2, 2012
Last Updated: March 14, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
Greece: National Organization of Medicines
Switzerland: Swissmedic

Keywords provided by AbbVie:
open-label
adalimumab
PIONEER (OPEN-LABEL EXTENSION)
hidradenitis suppurativa
acne inversa
 HS
tumor necrosis factor
boil
acne

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
 Infection
Suppuration
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013