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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hidradenitis Suppurativa

Intervention: Adalimumab (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Dawn Carlson, MD, Study Director, Affiliation: AbbVie

Summary

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.

Clinical Details

Official title: 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)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of subjects achieving clinical response

Detailed description: 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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who previously participated in a prior Phase 3 Abbott HS study and:

- Completed the study; or

- Experienced a loss of response (LOR); or

- 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.

Locations and Contacts

Site Reference ID/Investigator# 77946, Adelaide 5000, Australia

Site Reference ID/Investigator# 73539, Benowa 4217, Australia

Site Reference ID/Investigator# 73542, Brisbane 4102, Australia

Site Reference ID/Investigator# 73543, Brisbane 4102, Australia

Site Reference ID/Investigator# 73538, Carlton 3053, Australia

Site Reference ID/Investigator# 73540, Fremantle 6160, Australia

Site Reference ID/Investigator# 73541, Phillip 2606, Australia

Site Reference ID/Investigator# 73536, St. Leonards 2065, Australia

Site Reference ID/Investigator# 73537, Westmead 2145, Australia

Site Reference ID/Investigator# 66746, Barrie L4M 6L2, Canada

Site Reference ID/Investigator# 66747, Halifax B3H 1Z2, Canada

Site Reference ID/Investigator# 66748, Markham L3P 1X2, Canada

Site Reference ID/Investigator# 66743, Moncton E1C 8X3, Canada

Site Reference ID/Investigator# 114695, Peterborough K9J 5K2, Canada

Site Reference ID/Investigator# 66750, Quebec G1V 4X7, Canada

Site Reference ID/Investigator# 66744, St. John's A1C 2H5, Canada

Site Reference ID/Investigator# 96224, St. John's A1A 5E8, Canada

Site Reference ID/Investigator# 66742, Surrey V3V 0C6, Canada

Site Reference ID/Investigator# 66749, Waterloo N2J 1C4, Canada

Site Reference ID/Investigator# 66745, Winnipeg R3C 0N2, Canada

Site Reference ID/Investigator# 74335, Hradec Kralove 50005, Czech Republic

Site Reference ID/Investigator# 74334, Plzen-Bory 30599, Czech Republic

Site Reference ID/Investigator# 74333, Prague 10 10034, Czech Republic

Site Reference ID/Investigator# 74337, Prague 2 128 08, Czech Republic

Site Reference ID/Investigator# 74336, Usti nad Labem 40113, Czech Republic

Site Reference ID/Investigator# 73546, Aarhus C 8000, Denmark

Site Reference ID/Investigator# 73544, Copenhagen NV 2400, Denmark

Site Reference ID/Investigator# 73547, Hellerup 2900, Denmark

Site Reference ID/Investigator# 73545, Roskilde 4000, Denmark

Site Reference ID/Investigator# 73550, Nantes Cedex 1 44093, France

Site Reference ID/Investigator# 73548, Paris Cedex 10 75475, France

Site Reference ID/Investigator# 73549, Pessac 33604, France

Site Reference ID/Investigator# 73551, Poitiers Cedex 86021, France

Site Reference ID/Investigator# 76134, Reims Cedex 51090, France

Site Reference ID/Investigator# 74340, Berlin 10117, Germany

Site Reference ID/Investigator# 74338, Bochum 44791, Germany

Site Reference ID/Investigator# 74341, Darmstadt-Eberstadt 64297, Germany

Site Reference ID/Investigator# 74344, Dessau-Rosslau 06847, Germany

Site Reference ID/Investigator# 74343, Erlangen 91054, Germany

Site Reference ID/Investigator# 74339, Kiel 24105, Germany

Site Reference ID/Investigator# 74342, Mainz 55131, Germany

Site Reference ID/Investigator# 73614, Athens 16121, Greece

Site Reference ID/Investigator# 73617, Athens 16121, Greece

Site Reference ID/Investigator# 73615, Haidari, Athens 12462, Greece

Site Reference ID/Investigator# 73616, Thessaloniki 54643, Greece

Site Reference ID/Investigator# 74347, Budapest 1085, Hungary

Site Reference ID/Investigator# 74346, Miskolc 3529, Hungary

Site Reference ID/Investigator# 74348, Szeged 6720, Hungary

Site Reference ID/Investigator# 74350, Szombathely 9700, Hungary

Site Reference ID/Investigator# 73621, Amsterdam 1105 AZ, Netherlands

Site Reference ID/Investigator# 81913, Breda 4818 CK, Netherlands

Site Reference ID/Investigator# 73622, Rotterdam 3015 CA, Netherlands

Site Reference ID/Investigator# 61444, Carolina 00985, Puerto Rico

Site Reference ID/Investigator# 73627, Lund 22185, Sweden

Site Reference ID/Investigator# 73624, Stockholm 17176, Sweden

Site Reference ID/Investigator# 73631, Bern 3010, Switzerland

Site Reference ID/Investigator# 73630, Lausanne 1011, Switzerland

Site Reference ID/Investigator# 73628, St. Gallen 9007, Switzerland

Site Reference ID/Investigator# 73629, Zurich 8091, Switzerland

Site Reference ID/Investigator# 73633, Ankara 06100, Turkey

Site Reference ID/Investigator# 73636, Istanbul 34390, Turkey

Site Reference ID/Investigator# 95563, Birmingham, Alabama 35205, United States

Site Reference ID/Investigator# 61423, Bakersfield, California 93309, United States

Site Reference ID/Investigator# 66722, Mather, California 95655, United States

Site Reference ID/Investigator# 61441, Colorado Springs, Colorado 80915, United States

Site Reference ID/Investigator# 96223, Farmington, Connecticut 06032, United States

Site Reference ID/Investigator# 61430, Coral Gables, Florida 33134, United States

Site Reference ID/Investigator# 66729, Dunedin, Florida 34698, United States

Site Reference ID/Investigator# 61428, Jacksonville, Florida 32204, United States

Site Reference ID/Investigator# 61438, Orange Park, Florida 32073-4120, United States

Site Reference ID/Investigator# 104935, Tampa, Florida 33624, United States

Site Reference ID/Investigator# 61442, Atlanta, Georgia 30342, United States

Site Reference ID/Investigator# 96216, Macon, Georgia 31217, United States

Site Reference ID/Investigator# 58543, Newnan, Georgia 30263, United States

Site Reference ID/Investigator# 66724, Champaign, Illinois 61820, United States

Site Reference ID/Investigator# 96218, Chicago, Illinois 60611, United States

Site Reference ID/Investigator# 61427, Boston, Massachusetts 02111, United States

Site Reference ID/Investigator# 61431, Boston, Massachusetts 02114, United States

Site Reference ID/Investigator# 93373, Fort Gratiot, Michigan 48059, United States

Site Reference ID/Investigator# 61440, Grand Blanc, Michigan 48439, United States

Site Reference ID/Investigator# 66726, Troy, Michigan 48084, United States

Site Reference ID/Investigator# 66728, Omaha, Nebraska 68144, United States

Site Reference ID/Investigator# 114718, Henderson, Nevada 89074, United States

Site Reference ID/Investigator# 61436, Verona, New Jersey 07044, United States

Site Reference ID/Investigator# 96217, Bronx, New York 10467, United States

Site Reference ID/Investigator# 61434, Chapel Hill, North Carolina 27516, United States

Site Reference ID/Investigator# 61433, Winston-Salem, North Carolina 27103, United States

Site Reference ID/Investigator# 66725, Winston-Salem, North Carolina 27157, United States

Site Reference ID/Investigator# 61432, Cleveland, Ohio 44106, United States

Site Reference ID/Investigator# 61443, Gahanna, Ohio 43230, United States

Site Reference ID/Investigator# 61422, Hershey, Pennsylvania 17033, United States

Site Reference ID/Investigator# 61424, Pittsburgh, Pennsylvania 15213, United States

Site Reference ID/Investigator# 61426, Nashville, Tennessee 37215, United States

Site Reference ID/Investigator# 66723, San Antonio, Texas 78229, United States

Site Reference ID/Investigator# 61437, Norfolk, Virginia 23507, United States

Site Reference ID/Investigator# 111835, Seattle, Washington 98101, United States

Additional Information

United States Prescribing Information is provided. Important Note: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses

Starting date: April 2012
Last updated: July 13, 2015

Page last updated: August 23, 2015

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