Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice (HOPE)

AbbVie

Status: Completed

Conditions: Uveitis

Study type: Observational

Funder types: Industry

Identifiers

NCT03155243

P16-537

Details and patient eligibility

About

This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.

Enrollment: 155 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).

• Age >= 18 years at the time of the enrollment.

• Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:

  1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  2. >= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
  3. >= 2+ vitreous haze [National Eye Institute (NEI)/SUN criteria]

• Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.

• Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.

Exclusion criteria

• Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
• Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
• Participants currently participating in other clinical research.
• Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.

Trial design

155 participants in 1 patient group

Participants receiving adalimumab (Humira®)

Description:

Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®).