Clinical trial NCT03155243: 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: Humira®
Adalimumab
Ocular inflammation
Active non-infectious intermediate, posterior and panuveitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosed active non- infectious intermediate, posterior or panuveitis (NIIPPU) that are being treated with Humira® as per locally approved label and prescription guidelines.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of participants who achieve treatment response at any of the follow-up visits
timeFrame: Up to Month 12
Secondary outcomes:
measure: Proportion of participants with maintained response at any of follow up visits
timeFrame: Up to Month 12
measure: Percent change in Presenteeism
timeFrame: Up to Month 12
measure: Proportion of participants with maintained response separately for each follow-up visit
timeFrame: Up to Month 12
measure: Percent Change in Total activity impairment
timeFrame: Up to Month 12
measure: Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score
timeFrame: From Month 1 to Month 12
measure: Change in emergency room admissions
timeFrame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
measure: Proportion of participants with treatment response separately for each follow-up visit
timeFrame: Up to Month 12
measure: Change from baseline in Best corrected visual acuity (BCVA)
timeFrame: From Month 1 to Month 12
measure: Change in cumulative hospital admissions
timeFrame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
measure: Change from baseline in Central Retinal Thickness (CRT)
timeFrame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
measure: Proportion of participants with flare at any of follow up visit
timeFrame: Up to Month 12
measure: Percent change in Absenteeism
timeFrame: Up to Month 12
measure: Percent Change in Total work productivity impairment
timeFrame: Up to Month 12
measure: Change in outpatient visits
timeFrame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
measure: Change in hospitalization days prior to and during Humira® treatment
timeFrame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
measure: Change from baseline in intraocular pressure
timeFrame: From Month 1 to Month 12
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz /ID# 206301
state: Steiermark
city: Vienna
country: Austria
facility: Medical University of Vienna /ID# 206190
state: Wien
city: Barranquilla
country: Colombia
facility: Clinica Oftalmologica del Caribe /ID# 206448
state: Atlantico
city: Bucaramanga
country: Colombia
facility: Foscal /Id# 207362
city: Medellín
country: Colombia
facility: Fundacion hospitalaria San Vicente de Paul /ID# 208295
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice /ID# 209530
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum /ID# 204879
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf /ID# 205234
city: Munster
country: Germany
facility: St. Franziskus Hosp Muenster /ID# 206695
city: Athens
country: Greece
facility: Omma /Id# 163750
city: Athens
country: Greece
facility: Athens Eye Hospital /ID# 163751
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 163752
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center /ID# 163753
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 163647
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem /ID# 163646
city: Dublin
country: Ireland
facility: Royal Victoria Eye and Ear Hos /ID# 163653
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 163108
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 163024
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center /ID# 169305
state: Yerushalayim
city: Ashkelon
country: Israel
facility: Barzilai Medical Center /ID# 163025
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 163026
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 163109
city: Kuwait
country: Kuwait
facility: Albahar Ophtalmology Center /ID# 210124
city: Beirut
country: Lebanon
facility: American University of Beirut /ID# 210122
city: Zurich
country: Switzerland
facility: Stadtspital Triemli /ID# 206204
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsklinik /ID# 201027
city: Lausanne
country: Switzerland
facility: Hop Ophtalmique Jules Gonin /ID# 201028
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi /ID# 210123
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: