Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness (SOLACE)

AbbVie

Status: Completed

Conditions: Hidradenitis Suppurativa (HS)

Study type: Observational

Funder types: Industry

Identifiers

NCT02896920

P15-696

Details and patient eligibility

About

This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).

Enrollment: 165 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment
• Need a change in ongoing therapy for any reason, but not limited to inadequate response, intolerance, sub-optimal compliance, or patient preference. Patient will be approached to participate in the study after a decision to change patient's therapy for Humira® is made by the treating physician.
• Has provided written informed consent (Patient Authorization) for participation in the study

Exclusion criteria

• Is participating in a clinical interventional study
• Was treated with Humira®, or any other biologic agents for HS prior to baseline visit
• Has any other active skin disease or condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of HS

Trial design

165 participants in 1 patient group

Participants receiving adalimumab/ Humira®

Description:

Participants with HS for whom a change in treatment to Humira® is made by the treating physician