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

Uveitis Clinical Trial

— HOPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155243
• Other study ID #: P16-537
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: February 24, 2020

Study information

• Verified date: February 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Panuveitis
• Uveitis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percent change in Presenteeism	Assessing percent change in presenteeism	Up to Month 12
Secondary	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
Secondary	Percent Change in Total activity impairment	Assessing Percent Change in Total activity impairment	Up to Month 12
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Percent change in Absenteeism	Assessing percent change in absenteeism	Up to Month 12
Secondary	Percent Change in Total work productivity impairment	Assessing Percent Change in Total work productivity impairment	Up to Month 12
Secondary	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)
Secondary	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)
Secondary	Change from baseline in intraocular pressure	Assessing change from baseline in intraocular pressure	From Month 1 to Month 12

External Links

•   clinical study report synopsis