Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
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| ClinicalTrials.gov Identifier: NCT03894956 |
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Recruitment Status :
Completed
First Posted : March 29, 2019
Last Update Posted : January 18, 2022
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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 Type : | Observational |
| Actual Enrollment : | 46 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 |
| Actual Primary Completion Date : | November 10, 2021 |
| Actual Study Completion Date : | November 10, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
Drug Information available for:
Adalimumab
| Group/Cohort |
|---|
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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
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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
Locations
Show 37 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03894956 |
| Other Study ID Numbers: |
P18-835 |
| First Posted: | March 29, 2019 Key Record Dates |
| Last Update Posted: | January 18, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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:
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Hidradenitis Suppurativa (HS) Humira Adalimumab |
Additional relevant MeSH terms:
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |