Status:
COMPLETED
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Hidradenitis Suppurativa (HS)
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
Detailed Description
The clinical trial identifier is PIONEER I. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. ...
Eligibility Criteria
Inclusion
- Adults must have a diagnosis of 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 total AN count of greater than or equal to 3 at baseline.
Exclusion
- Subject was previously treated with adalimumab or another anti-tumor necrosis factor (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).
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT01468207
Start Date
November 1 2011
End Date
January 1 2014
Last Update
July 7 2021
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