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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT03155243

Collaborator

(none)

155

Enrollment

Locations

32.2

Actual Duration (Months)

5.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis

Study Design

Study Type:

Observational

Actual Enrollment :

155 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 20, 2017

Actual Primary Completion Date :

Feb 24, 2020

Actual Study Completion Date :

Feb 24, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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:

Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
= 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.

Contacts and Locations

Locations

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