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
630
mi
from 98109
Mather, CA
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8336
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from 98109
Adelaide,
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863
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from 98109
Bakersfield, CA
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2079
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from 98109
Birmingham, AL
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2485
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from 98109
Boston, MA
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2402
mi
from 98109
Bronx, NY
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1759
mi
from 98109
Champaign, IL
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2337
mi
from 98109
Chapel Hill, NC
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1733
mi
from 98109
Chicago, IL
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2020
mi
from 98109
Cleveland, OH
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Colorado Springs, Colorado 80910
1070
mi
from 98109
Colorado Springs, CO
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2730
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from 98109
Coral Gables, FL
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2509
mi
from 98109
Dunedin, FL
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2424
mi
from 98109
Farmington, CT
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1939
mi
from 98109
Fort Gratiot, MI
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2013
mi
from 98109
Gahanna, OH
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1887
mi
from 98109
Grand Blanc, MI
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885
mi
from 98109
Henderson, NV
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2293
mi
from 98109
Hershey, PA
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2449
mi
from 98109
Jacksonville, FL
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2255
mi
from 98109
Macon, GA
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1970
mi
from 98109
Nashville, TN
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2176
mi
from 98109
Newnan, GA
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2429
mi
from 98109
Norfolk, VA
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1366
mi
from 98109
Omaha, NE
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2457
mi
from 98109
Orange Park, FL
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2132
mi
from 98109
Pittsburgh, PA
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1790
mi
from 98109
San Antonio, TX
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2172
mi
from 98109
Sandy Springs, GA
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2
mi
from 98109
Seattle, WA
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2527
mi
from 98109
Tampa, FL
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1922
mi
from 98109
Troy, MI
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2387
mi
from 98109
Verona, NJ
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2275
mi
from 98109
Winston-Salem, NC
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