Uveitis Clinical Trial
Official title:
An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
NCT number | NCT01279954 |
Other study ID # | e7035 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | June 2017 |
Verified date | January 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | number of participants with adverse events | 2 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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