Abatacept in the Treatment of Uveitis

Phase 2

Completed

• Conditions: Uveitis
• Interventions: Drug: Abatacept

• Registration Number: NCT01279954
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Study Start: 2012-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Results First Submitted: 2018-09-08
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Results First Posted: 2019-02-21
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
open-label abatacept first, then 5 mg/kg abatacept	Abatacept	10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
open-label abatacept first, then 10 mg/kg abatacept	Abatacept	10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)

Primary Outcome Measures

Name	Time	Method
Adverse Events	2 years	number of participants with adverse events

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity	Week 24	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.
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%	Week 24	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.
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods	Week 24	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States