This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01635764
First received: March 2, 2012
Last updated: September 26, 2016
Last verified: September 2016
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Proportion of subjects achieving clinical response [ Time Frame: Baseline (Week 0) up to Week 60 ]
    Subjects achieving improvement in hidradenitis suppurativa severity


Enrollment: 510
Study Start Date: April 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (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 to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who previously participated in a prior Phase 3 Abbott HS study and:

    1. Completed the study; or
    2. Experienced a loss of response (LOR); or
    3. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635764

  Show 96 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Dawn Carlson, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01635764     History of Changes
Other Study ID Numbers: M12-555
2011-003478-98 ( EudraCT Number )
Study First Received: March 2, 2012
Last Updated: September 26, 2016

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

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

ClinicalTrials.gov processed this record on June 26, 2017