To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa (HIDRI2007)
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Apocrine glands, abcesses
Eligibility Criteria
Inclusion Criteria:
Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:
- HS >1 year duration with multiple ER or doctors visits related to HS
- Intralesional kenalog injection >5/year, however none within 2 weeks of entry
- Failed systemic retinoids, but not within 3 months of entry
- Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment)
- History of surgery (reconstructive), but not within 3 months of entry
Exclusion Criteria:
- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection).
- Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
- If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
- Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
- Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
- Have a concomitant diagnosis or history of congestive heart failure.
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI).
Secondary Outcome Measures
To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.
To evaluate the ability of adalimumab to maintain suppression of the disease.
Full Information
NCT ID
NCT00827996
First Posted
January 21, 2009
Last Updated
January 22, 2009
Sponsor
Florida Academic Dermatology Centers
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00827996
Brief Title
To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Acronym
HIDRI2007
Official Title
Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
August 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Florida Academic Dermatology Centers
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Apocrine glands, abcesses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
adalimumab
Intervention Description
Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12
Primary Outcome Measure Information:
Title
To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI).
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.
Time Frame
13 weeks
Title
To evaluate the ability of adalimumab to maintain suppression of the disease.
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:
HS >1 year duration with multiple ER or doctors visits related to HS
Intralesional kenalog injection >5/year, however none within 2 weeks of entry
Failed systemic retinoids, but not within 3 months of entry
Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment)
History of surgery (reconstructive), but not within 3 months of entry
Exclusion Criteria:
Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection).
Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
Have a concomitant diagnosis or history of congestive heart failure.
Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco A Kerdel, M.D
Organizational Affiliation
Florida Academic Dermatology Centers
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
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