Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa

Completed

• Conditions: Hidradenitis Suppurativa (HS)

• Registration Number: NCT03894956
• Lead Sponsor: AbbVie

Brief Summary

The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Study Start: 2019-05-02
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.

Exclusion Criteria

• Participants previously treated with Humira.
• Participants who do not provide consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants who reported any adverse drug reactions (ADRs) during the study	Up to Week 52	ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Percentage of participants who reported any serious infections during the study	Up to Week 52	Percentage of participants with incidence of serious infections are reported.
Percentage of participants who reported any infections during the study	Up to Week 52	Percentage of participants with incidence of infections are reported.

Secondary Outcome Measures

Name	Time	Method
Change in C-Reactive Protein (CRP)	From Baseline to Week 52	CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.
Percentage of participants achieving "Improved" of overall improvement by physician	Up to Week 52	Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.
Change in Dermatology Life Quality Index (DLQI)	From Baseline to Week 52	DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)	Up to week 52	HiSCR is defined as at least 50% reduction in the number of abscesses and inflammatory nodules and no increase in abscess count and no increase in draining fistula count relative to baseline.
Change in Patient's global assessment of skin pain	From Baseline to Week 52	Patient's global assessment of skin pain is evaluated on a 11-point scale with 0 for "no pain" and 10 for "worst skin pain imaginable."

Trial Locations

Locations (37)

Anjou Kousei Hospital /ID# 216741; 🇯🇵 Anjo-shi, Aichi, Japan

Ichinomiya Municipal Hospital /ID# 214086; 🇯🇵 Ichinomiya-shi, Aichi, Japan

Aichi Medical University Hospital /ID# 215312; 🇯🇵 Nagakute-shi, Aichi, Japan

NHO Nagoya Medical Center /ID# 214406; 🇯🇵 Nagoya-shi, Aichi, Japan

Nagoya University Hospital /ID# 214135; 🇯🇵 Nagoyashi, Aichi, Japan

Kimitsu Chuo Hospital /ID# 214733; 🇯🇵 Kisarazu-shi, Chiba, Japan

Ehime University Hospital /ID# 214090; 🇯🇵 Toon-shi, Ehime, Japan

Kyushu University Hospital /ID# 214092; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

JA Hiroshima General Hospital /ID# 213472; 🇯🇵 Hatsukaichi-shi, Hiroshima, Japan

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