Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa


Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

Acronym: PIONEER I
Other IDs: M11-313|2011-003400-20
NCT Number: NCT01468207
Sponsor Collaborators: AbbVie (prior sponsor, Abbott)|AbbVie
Funding: Industry


HIDRADENITIS SUPPURATIVA CLINICAL TRIAL STATUS

Recruiting Status: Completed
Recruiting Genders: Both
Recruiting Age Groups: Adult|Senior
Interventions: Biological: adalimumab|Biological: placebo
Phases: Phase 3


CLINICAL STUDY DETAILS & RESULTS

STUDY TYPES: Interventional
STUDY DESIGNS: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator)
Results First Received: September 16, 2015
Study Result (if available): Has Results
Primary Completion Date: January 2014
Outcome Measures: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient’s Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|Change From Baseline to Week 12 in Modified Sartorius Score


CLINICAL STUDIES DATES & MILESTONES

First Received: November 7, 2011
Start Date: November 2011
Completion Date: January 2014
Last Updated: October 15, 2015
last Verified: October 2015


Source: https://ClinicalTrials.gov/show/NCT01468207


Public Domain Source: ClinicalTrials.gov query for “Hidradenitis suppurativa” clinical studies (last updated January 2016).


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