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
- Conditions
- Uveitis
- Registration Number
- NCT03155243
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
-
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Percent change in Presenteeism Up to Month 12 Assessing percent change in presenteeism
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.
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
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
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 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 Best corrected visual acuity (BCVA) From Month 1 to Month 12 Assessing change from baseline in Best corrected visual acuity (BCVA)
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)
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 from baseline in intraocular pressure From Month 1 to Month 12 Assessing change from baseline in intraocular pressure
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
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.
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
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.
Trial Locations
- Locations (28)
Medizinische Universität Graz /ID# 206301
🇦🇹Graz, Steiermark, Austria
Medical University of Vienna /ID# 206190
🇦🇹Vienna, Wien, Austria
Clinica Oftalmologica del Caribe /ID# 206448
🇨🇴Barranquilla, Atlantico, Colombia
Fundacion hospitalaria San Vicente de Paul /ID# 208295
🇨🇴Medellín, Colombia
Rabin Medical Center /ID# 163108
🇮🇱Petakh Tikva, Tel-Aviv, Israel
Charite Campus Virchow-Klinikum /ID# 204879
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf /ID# 205234
🇩🇪Hamburg, Germany
St. Franziskus Hosp Muenster /ID# 206695
🇩🇪Munster, Germany
Omma /Id# 163750
🇬🇷Athens, Greece
University General Hospital of Ioannina /ID# 163752
🇬🇷Ioannina, Greece
Interbalkan Medical Center /ID# 163753
🇬🇷Thessaloniki, Greece
Semmelweis Egyetem /ID# 163647
🇭🇺Budapest, Hungary
Sheba Medical Center /ID# 163109
🇮🇱Ramat Gan, Israel
American University of Beirut /ID# 210122
🇱🇧Beirut, Lebanon
Stadtspital Triemli /ID# 206204
🇨🇭Zurich, Zuerich, Switzerland
Inselspital, Universitaetsklinik /ID# 201027
🇨🇭Bern, Switzerland
Hop Ophtalmique Jules Gonin /ID# 201028
🇨🇭Lausanne, Switzerland
Cleveland Clinic Abu Dhabi /ID# 210123
🇦🇪Abu Dhabi, United Arab Emirates
Royal Victoria Eye and Ear Hos /ID# 163653
🇮🇪Dublin, Ireland
Barzilai Medical Center /ID# 163025
🇮🇱Ashkelon, Israel
Foscal /Id# 207362
🇨🇴Bucaramanga, Colombia
Vseobecna Fakultni Nemocnice /ID# 209530
🇨🇿Prague, Czechia
Athens Eye Hospital /ID# 163751
🇬🇷Athens, Greece
Szegedi Tudomanyegyetem /ID# 163646
🇭🇺Szeged, Hungary
Tel Aviv Sourasky Medical Ctr /ID# 163024
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Hadassah Medical Center /ID# 169305
🇮🇱Jerusalem, Yerushalayim, Israel
Bnai Zion Medical Center /ID# 163026
🇮🇱Haifa, Israel
Albahar Ophtalmology Center /ID# 210124
🇰🇼Kuwait, Kuwait