Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa (HS), Humira, Adalimumab
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who reported any serious infections during the study | 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 | 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 | Up to Week 52 | Percentage of participants with incidence of infections are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient's global assessment of skin pain | 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. |
| Percentage of participants achieving Improved of overall improvement by physician | Up to Week 52 | Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician. |
| Change in Dermatology Life Quality Index (DLQI) | From Baseline to Week 52 | DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life. |
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) | 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) | From Baseline to Week 52 | CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation. |
Countries
Japan
Outcome results
None listed