Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

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Detailed Description

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HS 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.

Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab Every Week

Adalimumab 40 mg every week.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

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adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira

Eligibility Criteria

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Inclusion Criteria

* Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) 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-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie 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 AbbVie HS study.
* Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No