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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT03155243
• Date of registration: 15/05/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific title: 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
• Date of first enrolment: June 20, 2017
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03155243
• Study type: Observational

Countries of recruitment

Austria, Colombia, Czechia, Germany, Greece, Hungary, Ireland, Israel, Kuwait, Lebanon, Switzerland, United Arab Emirates

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Uveitis

Primary Outcome(s)

Proportion of participants who achieve treatment response at any of the follow-up visits [Time Frame: Up to Month 12]

Secondary Outcome(s)

Change in emergency room admissions [Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)]

Percent Change in Total work productivity impairment [Time Frame: Up to Month 12]

Change from baseline in intraocular pressure [Time Frame: From Month 1 to Month 12]

Percent change in Presenteeism [Time Frame: Up to Month 12]

Proportion of participants with maintained response at any of follow up visits [Time Frame: Up to Month 12]

Change from baseline in Best corrected visual acuity (BCVA) [Time Frame: From Month 1 to Month 12]

Change from baseline in Central Retinal Thickness (CRT) [Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)]

Percent change in Absenteeism [Time Frame: Up to Month 12]

Change in outpatient visits [Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)]

Percent Change in Total activity impairment [Time Frame: Up to Month 12]

Proportion of participants with flare at any of follow up visit [Time Frame: Up to Month 12]

Change in cumulative hospital admissions [Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)]

Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score [Time Frame: From Month 1 to Month 12]

Proportion of participants with maintained response separately for each follow-up visit [Time Frame: Up to Month 12]

Change in hospitalization days prior to and during Humira® treatment [Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)]

Proportion of participants with treatment response separately for each follow-up visit [Time Frame: Up to Month 12]

Secondary ID(s)

P16-537

Source(s) of Monetary Support

Please refer to primary and secondary sponsors