Abatacept in the Treatment of Uveitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

Official Title
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An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.

Conditions
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Uveitis

Intervention / Treatment
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* Drug: Abatacept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with vision-threatening autoimmune uveitis failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects Exclusion Criteria: serious concomitant illness that could interfere with the subject's participation

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open-label abatacept first, then 5 mg/kg abatacept<br>10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months) | Drug: Abatacept<br>* Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg. Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.<br>* Other names: orencia;|
| Experimental: open-label abatacept first, then 10 mg/kg abatacept<br>10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months) | Drug: Abatacept<br>* Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg. Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.<br>* Other names: orencia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | number of participants with adverse events | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity | improvement by 2 or more lines of best-corrected visual acuity With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks. | Week 24 | 
| Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% | Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks. | Week 24 | 
| Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods | Reduction of AC cellular activity and/or vitreous haze by 2 grades. Reduction of chorioretinal infiltrates or reduction of retinal vasculitis. Reduction of cystoid macular edema and/or retinal inflammation. With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks. | Week 24 |