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 : May 30, 2019
|Condition or disease|
|Hidradenitis Suppurativa (HS)|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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."
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894956
|Contact: AbbVie GK Clinical Trial Registration Deskfirstname.lastname@example.org|
|JA Hiroshima General Hospital /ID# 213472||Recruiting|
|Hiroshima, Japan, 738-8503|
|Study Director:||AbbVie Inc.||AbbVie|