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

NCT03894956 | Completed

• 1 other identifier: P18-835
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 37

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.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativa (HS); Humira; Adalimumab

Outcome Measures

Primary Outcomes (3)

• Percentage of participants who reported any serious infections during the study

  Percentage of participants with incidence of serious infections are reported.

  Up to Week 52

• Percentage of participants who reported any adverse drug reactions (ADRs) during the study

  ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.

  Up to Week 52

• Percentage of participants who reported any infections during the study

  Percentage of participants with incidence of infections are reported.

  Up to Week 52

Secondary Outcomes (5)

• Percentage of participants achieving "Improved" of overall improvement by physician

  Up to Week 52

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)

  Up to week 52

• Change in C-Reactive Protein (CRP)

  From Baseline to Week 52

• Change in Patient's global assessment of skin pain

  From Baseline to Week 52

• Change in Dermatology Life Quality Index (DLQI)

  From Baseline to Week 52

Study Arms (1)

Participants with Hidradenitis Suppurativa (HS)

Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hidradenitis Suppurativa (HS)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (37)

Anjou Kousei Hospital /ID# 216741

Anjo-shi, Aichi-ken, 446-8602, Japan

Location

Ichinomiya Municipal Hospital /ID# 214086

Ichinomiya-shi, Aichi-ken, 491-8558, Japan

Location

Aichi Medical University Hospital /ID# 215312

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

NHO Nagoya Medical Center /ID# 214406

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya University Hospital /ID# 214135

Nagoya, Aichi-ken, 4668560, Japan

Location

Kimitsu Chuo Hospital /ID# 214733

Kisarazu-shi, Chiba, 292-8535, Japan

Location

Ehime University Hospital /ID# 214090

Toon-shi, Ehime, 791-0295, Japan

Location

Kyushu University Hospital /ID# 214092

Fukuoka, Fukuoka, 812-8582, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

JA Hiroshima General Hospital /ID# 213472

Hatsukaichi-shi, Hiroshima, 738-8503, Japan

Location

Sapporo Higashi Tokushukai Hospital /ID# 213865

Sapporo, Hokkaido, 065-0033, Japan

Location

Kobe University Hospital /ID# 215642

Kobe, Hyōgo, 650-0017, Japan

Location

Bito Dermatology Clinic /ID# 215316

Kobe, Hyōgo, 651-0095, Japan

Location

Takarazuka City Hospital /ID# 214088

Takarazuka-shi, Hyōgo, 665-0827, Japan

Location

Mito Kyodo General Hospital /ID# 214089

Mito, Ibaraki, 310-0015, Japan

Location

Yokohama City University Medical Center /ID# 216740

Yokohama, Kanagawa, 232-0024, Japan

Location

Yokosuka Kyosai Hospital /ID# 215310

Yokosuka-shi, Kanagawa, 238-8558, Japan

Location

Kochi Medical School Hospital /ID# 214091

Nankoku-shi, Kochi, 783-8505, Japan

Location

Kyoto University Hospital /ID# 215315

Kyoto, Kyoto, 606-8507, Japan

Location

Yokkaichi Municipal Hospital /ID# 215641

Yokkaichi-shi, Mie-ken, 510-0822, Japan

Location

Tohoku University Hospital /ID# 217830

Sendai, Miyagi, 9808574, Japan

Location

Tohoku Rosai Hospital /ID# 214084

Sendai, Miyagi, 981-8563, Japan

Location

Nara Hospital Kinki University Faculty of Medicine, /ID# 218640

Ikoma-shi, Nara, 630-0227, Japan

Location

Okayama University Hospital /ID# 215317

Okayama, Okayama-ken, 700-8558, Japan

Location

University of the Ryukyus Hospital /ID# 214136

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Kishiwada City Hospital /ID# 213471

Kishiwada-shi, Osaka, 596-8501, Japan

Location

Kindai University Hospital /ID# 217831

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Osaka University Hospital /ID# 215314

Suita-shi, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 214087

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Saitama Medical University Hospital /ID# 215599

Iruma-gun, Saitama, 350-0495, Japan

Location

Saitama Medical Center /ID# 218639

Kawagoe-shi, Saitama, 350-8550, Japan

Location

JA Shizuoka Kohseiren Ensh Hospital /ID# 218160

Hamamatsu, Shizuoka, 430-0929, Japan

Location

Shizuoka City Shizuoka Hospital /ID# 217292

Shizuoka, Shizuoka, 420-0853, Japan

Location

Toranomon Hospital /ID# 213470

Minato-ku, Tokyo, 105-8470, Japan

Location

Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134

Shinjuku-ku, Tokyo, 169-0073, Japan

Location

Toyama University Hospital /ID# 214407

Toyama, Toyama, 930-0194, Japan

Location

Japanese Red Cross Kitami Hospital /ID# 214085

Hokkaido, 078-8510, Japan

Location

Related Publications (2)

• Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023 Aug;50(8):1034-1044. doi: 10.1111/1346-8138.16835. Epub 2023 Jun 2.

  PMID: 37264993 DERIVED

• Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17.

  PMID: 35040156 DERIVED

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: May 2, 2019
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

JP (37)