A Phase 2 interventional study of Abatacept in Uveitis, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
345 studies on the registry are indexed under Uveitis; 38 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 214 interventional studies indexed under Uveitis.
Browse Uveitis studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
Drug: Abatacept
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
Drug: Abatacept
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.
Also known as: orencia
Adverse Events
number of participants with adverse events
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24
| Milestone | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5mg/kg Abatacept |
|---|---|---|
| Started | 5 | 5 |
| Completed | 2 | 1 |
| Not completed | 3 | 4 |
| Withdrew: Lack of efficacy | 3 | 4 |
number of participants with adverse events
| Participants | Randomized 10 mg/kg Abatacept | Randomized 5 mg/kg Abatacept | Open Label Abatacept |
|---|---|---|---|
| Adverse Events | 0 | 0 | 0 |
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.
| Participants | Open-label Abatacept |
|---|---|
| Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity | 0 |
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.
| Participants | Open-label Abatacept |
|---|---|
| Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% | 6 |
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.
| Participants | Open-label Abatacept |
|---|---|
| Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods | 4 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10 mg/kg Abatacept | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| 5 mg/kg Abatacept | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Open Label Abatacept | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| <=18 years | 2 | 1 | 3 |
| Between 18 and 65 years | 3 | 4 | 7 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 5 | 4 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
| Ocular Inflammation(Participants) | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| Count of participants | 4 | 5 | 9 |
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Studies of the drug tested here: Abatacept
Oregon Health and Science University →