Clinical trial NCT00827996: To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Apocrine glands
abcesses
Lead sponsor: Florida Academic Dermatology Centers
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2009-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Subjects with moderate to severe HS as defined by a HSSI \> 8 AND at least ONE of the following:

1. HS \>1 year duration with multiple ER or doctors visits related to HS
2. Intralesional kenalog injection \>5/year, however none within 2 weeks of entry
3. Failed systemic retinoids, but not within 3 months of entry
4. 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)
5. History of surgery (reconstructive), but not within 3 months of entry

Exclusion Criteria:

1. 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).
2. Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
3. If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
4. Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
5. 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.
6. 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.
7. Have a concomitant diagnosis or history of congestive heart failure.
8. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.

Primary outcomes:
measure: 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).
timeFrame: 13 weeks
Secondary outcomes:
measure: To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.
timeFrame: 13 weeks
measure: To evaluate the ability of adalimumab to maintain suppression of the disease.
timeFrame: 13 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Florida Academic Dermatology Centers
name: Francisco A Kerdel, M.D
role: PRINCIPAL_INVESTIGATOR
References: