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Completed

NCT Number: NCT03894956

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

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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anjou Kousei Hospital /ID# 216741, Anjo-shi, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of participants who reported any serious infections during the study

    Time frame: Up to Week 52

    Percentage of participants with incidence of serious infections are reported.

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

    Time frame: Up to Week 52

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

  3. Percentage of participants who reported any infections during the study

    Time frame: Up to Week 52

    Percentage of participants with incidence of infections are reported.

Secondary outcomes

  1. Percentage of participants achieving "Improved" of overall improvement by physician

    Time frame: Up to Week 52

    Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.

  2. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)

    Time frame: 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.

  3. Change in C-Reactive Protein (CRP)

    Time frame: From Baseline to Week 52

    CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.

  4. Change in Patient's global assessment of skin pain

    Time frame: 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."

  5. Change in Dermatology Life Quality Index (DLQI)

    Time frame: From Baseline to Week 52

    DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2019
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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