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

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ClinicalTrials.gov Identifier: NCT03894956
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hidradenitis Suppurativa (HS)

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hidradenitis Suppurativa (HS)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894956


Contacts
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Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com

Locations
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Japan
JA Hiroshima General Hospital /ID# 213472 Recruiting
Hiroshima, Japan, 738-8503
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03894956     History of Changes
Other Study ID Numbers: P18-835
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AbbVie:
Hidradenitis Suppurativa (HS)
Humira
Adalimumab

Additional relevant MeSH terms:
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Sweat Gland Diseases
Hidradenitis
Hidradenitis Suppurativa
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents