A multicenter study of the safety and efficacy of adalimumab in subjectswith moderate to severe hidradenitis suppurativa

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; Hidradenitis Suppurativa

• Registration Number: EUCTR2011-003478-98-DK
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-25
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. 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.
2. 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.
3. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified