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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving adalimumab (Humira®) | Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®). |
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| 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 |
| 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 |
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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:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna /ID# 206190 | Vienna | State of Vienna | 1090 | Austria | ||
| Medizinische Universität Graz /ID# 206301 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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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 |
| Graz |
| Styria |
| 8010 |
| Austria |
| Clinica Oftalmologica del Caribe /ID# 206448 | Barranquilla | Atlántico | 080020 | Colombia |
| Foscal /Id# 207362 | Bucaramanga | 680001 | Colombia |
| Fundacion hospitalaria San Vicente de Paul /ID# 208295 | Medellín | 050010 | Colombia |
| Vseobecna Fakultni Nemocnice /ID# 209530 | Prague | 128 08 | Czechia |
| Charite Campus Virchow-Klinikum /ID# 204879 | Berlin | 13353 | Germany |
| Universitätsklinikum Hamburg-Eppendorf /ID# 205234 | Hamburg | 20251 | Germany |
| St. Franziskus Hosp Muenster /ID# 206695 | Münster | 48145 | Germany |
| Omma /Id# 163750 | Athens | 11525 | Greece |
| Athens Eye Hospital /ID# 163751 | Athens | 16675 | Greece |
| University General Hospital of Ioannina /ID# 163752 | Ioannina | 45500 | Greece |
| Interbalkan Medical Center /ID# 163753 | Thessaloniki | 57001 | Greece |
| Semmelweis Egyetem /ID# 163647 | Budapest | 1085 | Hungary |
| Szegedi Tudomanyegyetem /ID# 163646 | Szeged | 6720 | Hungary |
| Royal Victoria Eye and Ear Hos /ID# 163653 | Dublin | 2 | Ireland |
| Hadassah Medical Center /ID# 169305 | Jerusalem | Jerusalem | 91120 | Israel |
| Rabin Medical Center /ID# 163108 | Petakh Tikva | Tel Aviv | 4941492 | Israel |
| Tel Aviv Sourasky Medical Ctr /ID# 163024 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Barzilai Medical Center /ID# 163025 | Ashkelon | 78278 | Israel |
| Bnai Zion Medical Center /ID# 163026 | Haifa | 3339419 | Israel |
| Sheba Medical Center /ID# 163109 | Ramat Gan | 5262100 | Israel |
| Albahar Ophtalmology Center /ID# 210124 | Kuwait City | 35151 | Kuwait |
| American University of Beirut /ID# 210122 | Beirut | 1107 | Lebanon |
| Stadtspital Triemli /ID# 206204 | Zurich | Canton of Zurich | 8063 | Switzerland |
| Inselspital, Universitaetsklinik /ID# 201027 | Bern | 3010 | Switzerland |
| Hop Ophtalmique Jules Gonin /ID# 201028 | Lausanne | 1000 | Switzerland |
| Cleveland Clinic Abu Dhabi /ID# 210123 | Abu Dhabi | United Arab Emirates |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D015864 | Panuveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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