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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003653-16 | EudraCT Number | ||
| IM101-794 | Other Grant/Funding Number | BMS |
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| Name | Class |
|---|---|
| Ziekenhuis Netwerk Antwerpen (ZNA) | OTHER |
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To assess the efficacy and safety of Abatacept as an immunosuppressive treatment in Birdshot uveitis. The primary objective is to test the efficacy to suppress inflammation in active Birdshot uveitis patients, using quantitative and qualitative measurements of visual function.
To assess the efficacy and safety of Abatacept as an immunosuppressive treatment in Birdshot uveitis. The primary objective is to assess the efficacy to suppress active uveitis in Birdshot uveitis and to induce inflammatory remission during the 1 year treatment and after 2 years of treatment. Treatment efficacy will be assessed, using quantitative and qualitative measurements of visual function. In this trial we will also assess the utility of quantitative outcome measures in detecting disease activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept 125 MG/ML Prefilled Syringe | Experimental | Participants will inject the drug at home on a weekly basis. Participants will receive the syringes on the visit dates, supplying them for the period until the next visit. At baseline, participants will be explained and shown how to inject the drug themselves. Subject will have to stop all concomitant immunosuppressive drugs at baseline, e.g. Corticosteroids, Methotrexate, Mofetil Mycophenolate, Azathioprine, Tacrolimus, Sirolimus or Cyclosporin. Other drugs can be continued. In case of recurrence in the abatacept group, the study will end for that subject. Patients treated with abatacept (ORENCIA) may receive concurrent vaccinations, except for live vaccines. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept 125 MG/ML Prefilled Syringe | Drug | Abatacept 125 MG/ML Prefilled Syringe [Orencia] weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| time to recurrence in ≥1 eye | Patients are assessed for recurrence, if at least 1 of the following criteria are fulfilled in at least 1 eye.
| 1 year and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit | Vitreous haze is measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. |
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Inclusion Criteria:
Subject is at least 18 years of age.
Subject is diagnosed with Birdshot uveitis, HLA A 29+
Subject must have active disease at the Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye :
-Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesions
-≥ 1+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
Subjects who do not have previous, active or latent tuberculosis (TB). Subjects with negative QuantiFERON®-TB Gold test (or interferon-gamma release assay (IGRA) equivalent) are eligible. Subjects with a repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent) result are not eligible. The TB screening tests are diagnostic tests. In the event of a negative TB screening test, the results are to be interpreted in the context of the patient's epidemiology, history, exam findings, etc. and it is the responsibility of the investigator to determine if a patient has previous, active or latent tuberculosis or not. Under no circumstances can a patient with a positive QuantiFERON®-TB Gold test (or IGRA equivalent) enter the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter-Paul FA Schauwvlieghe, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36585127 | Derived | Schauwvlieghe PP, Van Calster J, Herbort CP Jr, Kestelyn PA, de Vlam K. Efficacy and safety of abatacept to treat active birdshot uveitis: a prospective open label interventional proof-of-concept trial. Br J Ophthalmol. 2024 Jan 29;108(2):244-252. doi: 10.1136/bjo-2022-321585. |
| Label | URL |
|---|---|
| Belgian Dataprotection Authority | View source |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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Prospective 0pen Label Interventional Proof-of-Concept Study
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| 1 year and 2 years |
| Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit | Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. | 1 year and 2 years |
| Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Baseline | Optical coherence tomography is performed at every visit using the Zeiss Cirrus OCT. Images are evaluated by a central reader (PI). Macular edema is defined as cystoid macular edema. OCT evidence of macular edema on or after Baseline is to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema are to be considered as censored observations at the time of dropping out. Optical Coherence Tomography will be measured using the Zeiss Cirrus OCT. For each eye a macular cube slab 512x128 and 2 HD 5 lines rasters (1 on 180° and 1 on 90°) will be taken, centered on the fovea. | 1 year and 2 years |
| Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit | Optical coherence tomography is performed at every visit using the Zeiss Cirrus OCT.Retinal thickness will be measured on the macular cube slab centered on the fovea. This will be measured by a central reader (PI). | 1 year and 2 years |
| Percent Change in Choroidal Thickness in Each Eye From Best State Achieved Prior to week 6 to the Final/Early Termination Visit | Choroidal thickness will be measured using the EDI mode of the Zeiss Cirrus OCT (HD 5 lines raster) and will be measured by a central reader (PI). | 1 year and 2 years |
| Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Baseline to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning | 1 year and 2 years |
| Change in scoring of Dual Fluorescein and ICG (Indocyanine Green) angiography from best state achieved | Change in scoring of Dual Fluorescein and ICG (Indocyanine Green) angiography from best state achieved, as defined by the Angiography Scoring for Uveitis Working group using the Heidelberg Scanning LASER fluorescein and ICG angiography | 1 year and 2 years |
| Change in Full Field ElectroRetinoGraphy (ERG) using the ISCEV standard protocols from baseline until the Final Visit | Quantitative values, such as 30 Hz implicit time, amplitude in a and b wave and latency will be recorded | 1 year and 2 years |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |