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Clinical Study Protocol M12-555 - PIONEER (Open-Label Extension) A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa


Phase 3
18 Years
N/A
Open (Enrolling by invite only)
Both
Hidradenitis Suppurativa

Thank you

Trial Information

Clinical Study Protocol M12-555 - PIONEER (Open-Label Extension) A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa


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:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects achieving clinical response.

Outcome Description:

Subjects achieving improvement in hidradenitis suppurativa severity.

Outcome Time Frame:

Baseline (Week 0) up to Week 60.

Safety Issue:

No

Principal Investigator

David Williams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AbbVie

Authority:

Canada: Health Canada

Study ID:

M12-555

NCT ID:

NCT01635764

Start Date:

April 2012

Completion Date:

July 2015

Related Keywords:

  • Hidradenitis Suppurativa
  • open-label
  • adalimumab
  • PIONEER (OPEN-LABEL EXTENSION)
  • hidradenitis suppurativa
  • acne inversa
  • HS
  • tumor necrosis factor
  • boil
  • acne
  • Hidradenitis
  • Hidradenitis Suppurativa

Name

Location
Site Reference ID/Investigator# 61423 Bakersfield, California  93309
Site Reference ID/Investigator# 61430 Miami, Florida  33136
Site Reference ID/Investigator# 61438 Orange Park, Florida  32073-4120
Site Reference ID/Investigator# 61442 Atlanta, Georgia  30327
Site Reference ID/Investigator# 58543 Newnan, Georgia  30263
Site Reference ID/Investigator# 61440 Grand Blanc, Michigan  48439
Site Reference ID/Investigator# 66728 Omaha, Nebraska  68144
Site Reference ID/Investigator# 61436 Verona, New Jersey  07044
Site Reference ID/Investigator# 61433 Winston-Salem, North Carolina  27103
Site Reference ID/Investigator# 61426 Nashville, Tennessee  37215
Site Reference ID/Investigator# 66723 San Antonio, Texas  78229
Site Reference ID/Investigator# 61437 Norfolk, Virginia  23507
Site Reference ID/Investigator# 95563 Birmingham, Alabama  35205
Site Reference ID/Investigator# 96222 Encino, California  91436
Site Reference ID/Investigator# 61441 Colorado Springs, Colorado  80915
Site Reference ID/Investigator# 66729 Dunedin, Florida  34698
Site Reference ID/Investigator# 61428 Jacksonville, Florida  32204
Site Reference ID/Investigator# 61427 Boston, Massachusetts  02111
Site Reference ID/Investigator# 61431 Boston, Massachusetts  02114
Site Reference ID/Investigator# 66726 Troy, Michigan  48084
Site Reference ID/Investigator# 61434 Chapel Hill, North Carolina  27516
Site Reference ID/Investigator# 66725 Winston-Salem, North Carolina  27157
Site Reference ID/Investigator# 61432 Cleveland, Ohio  44106
Site Reference ID/Investigator# 61443 Columbus, Ohio  43210
Site Reference ID/Investigator# 61424 Pittsburgh, Pennsylvania  15213