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)

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

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.

Study Overview

• Status: Completed
• Conditions: Uveitis

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Austria
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medizinische Universität Graz /ID# 206301
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medical University of Vienna /ID# 206190
• Colombia
  • Bucaramanga, Colombia, 680001
    • Foscal /Id# 207362
  • Medellín, Colombia, 050010
    • Fundacion hospitalaria San Vicente de Paul /ID# 208295
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica Oftalmologica del Caribe /ID# 206448
• Czechia
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice /ID# 209530
• Germany
  • Berlin, Germany, 13353
    • Charite Campus Virchow-Klinikum /ID# 204879
  • Hamburg, Germany, 20251
    • Universitätsklinikum Hamburg-Eppendorf /ID# 205234
  • Munster, Germany, 48145
    • St. Franziskus Hosp Muenster /ID# 206695
• Greece
  • Athens, Greece, 11525
    • Omma /Id# 163750
  • Athens, Greece, 16675
    • Athens Eye Hospital /ID# 163751
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina /ID# 163752
  • Thessaloniki, Greece, 57001
    • Interbalkan Medical Center /ID# 163753
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 163647
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem /ID# 163646
• Ireland
  • Dublin, Ireland, 2
    • Royal Victoria Eye and Ear Hos /ID# 163653
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center /ID# 163025
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center /ID# 163026
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center /ID# 163109
  • Tel-Aviv
    • Petakh Tikva, Tel-Aviv, Israel, 4941492
      • Rabin Medical Center /ID# 163108
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Ctr /ID# 163024
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center /ID# 169305
• Kuwait
  • Kuwait, Kuwait, 35151
    • Albahar Ophtalmology Center /ID# 210124
• Lebanon
  • Beirut, Lebanon, 1107
    • American University of Beirut /ID# 210122
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsklinik /ID# 201027
  • Lausanne, Switzerland, 1000
    • Hop Ophtalmique Jules Gonin /ID# 201028
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8063
      • Stadtspital Triemli /ID# 206204
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic Abu Dhabi /ID# 210123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieve treatment response at any of the follow-up visits	Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.	Up to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with maintained response at any of follow up visits	Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.	Up to Month 12
Percent change in Presenteeism	Assessing percent change in presenteeism	Up to Month 12
Proportion of participants with maintained response separately for each follow-up visit	Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.	Up to Month 12
Percent Change in Total activity impairment	Assessing Percent Change in Total activity impairment	Up to Month 12
Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score	Assessing changes in total score of WPAI-UV score	From Month 1 to Month 12
Change in emergency room admissions	Assessing change in emergency room admissions	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	Response is defined as participants with no new active inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.	Up to Month 12
Change from baseline in Best corrected visual acuity (BCVA)	Assessing change from baseline in Best corrected visual acuity (BCVA)	From Month 1 to Month 12
Change in cumulative hospital admissions	Assessing change in cumulative hospital admissions	From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in Central Retinal Thickness (CRT)	Assessing change from baseline in Central Retinal Thickness (CRT)	From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Proportion of participants with flare at any of follow up visit	Flare is defined as new active inflammatory lesions or AC cell grade of >=2+ or VH grade of >=2+ at least in one eye.	Up to Month 12
Percent change in Absenteeism	Assessing percent change in absenteeism	Up to Month 12
Percent Change in Total work productivity impairment	Assessing Percent Change in Total work productivity impairment	Up to Month 12
Change in outpatient visits	Assessing change in outpatient visits	From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change in hospitalization days prior to and during Humira® treatment	Assessing change in hospitalization days prior to and during Humira® treatment	From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in intraocular pressure	Assessing change from baseline in intraocular pressure	From Month 1 to Month 12

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2017
• Primary Completion (ACTUAL): February 24, 2020
• Study Completion (ACTUAL): February 24, 2020

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Adalimumab; Ocular inflammation; Humira®; Active non-infectious intermediate, posterior and panuveitis
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Inflammation; Uveitis; Panuveitis
• Other Study ID Numbers: P16-537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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.: No