Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894956
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com

Locations
Layout table for location information
Japan
Ehime University Hospital /ID# 214090 Recruiting
Toon, Japan, 791-0204
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03894956    
Other Study ID Numbers: P18-835
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration