Uveitis
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
Interventions
DRUGAbatacept
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.
Sponsors
Bristol-Myers Squibb
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 2 years | number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label Abatacept, Then 10 mg/kg Abatacept 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 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. | 5 |
| Open-label Abatacept, Then 5 mg/kg Abatacept 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 5 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. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 3 | 4 |
Baseline characteristics
| Characteristic | Open-label Abatacept, Then 10 mg/kg Abatacept | Open-label Abatacept, Then 5 mg/kg Abatacept | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ocular Inflammation | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 10 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 10 |
Outcome results
Primary
Adverse Events
number of participants with adverse events
Time frame: 2 years
Population: 2 subjects were randomized to the 5 mg/kg abatacept group but one of these subjects only received 1 treatment before being removed from the study due to worsening. Only 1 of the 2 subjects randomized to this group completed the study. This explains the discrepancy between this table and the participant flow.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized 10 mg/kg Abatacept | Adverse Events | 0 Participants |
| Randomized 5 mg/kg Abatacept | Adverse Events | 0 Participants |
| Open Label Abatacept | Adverse Events | 0 Participants |
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.
Time frame: Week 24
Population: With the outcome measure being at 24 weeks, only one group is analyzed. All 10 subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized 10 mg/kg Abatacept | Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods | 4 Participants |
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.
Time frame: Week 24
Population: All subjects started the trial on open label abatacept, so only one group is being analyzed for this 24 week outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized 10 mg/kg Abatacept | Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity | 0 Participants |
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.
Time frame: Week 24
Population: With the outcome measure being at 24 weeks, only one group is analyzed. All 10 subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized 10 mg/kg Abatacept | Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% | 6 Participants |