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



Status:Active, not recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 99
Updated:7/23/2016
Start Date:April 2012
End Date:September 2016

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A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

Hidradenitis Suppurativa 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. The
purpose of this study to evaluate the long term safety, tolerability and efficacy of
adalimumab in subjects with moderate to severe HS.

The purpose of this study to evaluate the long term safety, tolerability and efficacy of
adalimumab in subjects with moderate to severe HS. The clinical trial identifier is PIONEER
(OPEN-LABEL EXTENSION).

Inclusion Criteria:

- Subjects who previously participated in a prior Phase 3 Abbott HS study 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-TNF therapy (e.g., infliximab, etanercept), or
participation in an adalimumab trial other than a prior Phase 3 Abbott 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 Abbott HS study.

- Subject received oral concomitant analgesics (including opioids) for HS-related pain
within 14 days prior to the Baseline visit, except for permitted analgesics taken in
the prior Phase 3 Abbott HS study.
We found this trial at
34
sites
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Gahanna, OH
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Adelaide,
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Chicago, IL
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Cleveland, OH
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Colorado Springs, Colorado 80910
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Coral Gables, FL
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Dunedin, FL
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Mather, CA
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Newnan, GA
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Norfolk, VA
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Omaha, NE
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Verona, NJ
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Winston-Salem, NC
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