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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label abatacept first, then 5 mg/kg abatacept | Experimental | 10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months) |
|
| open-label abatacept first, then 10 mg/kg abatacept | Experimental | 10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | number of participants with adverse events | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric B. Suhler, MD, MPH | Oregon Health and Science University | Principal Investigator |
| James T Rosenbaum, MD | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Open-label Abatacept, Then 5mg/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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | number of participants with adverse events | 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. | Posted | Count of Participants | Participants | 2 years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 receive 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Suler, MD | Oregon Health & Science University | 503-494-5023 | suhlere@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2012 | Sep 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
|
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Inflammation | Ocular inflammation present at baseline, judged by fluorescein angiography, vitreous haze, and/or anterior chamber inflammation. | Count of Participants | Participants |
|
| OG001 | Randomized 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 receive 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. |
| OG002 | Open Label Abatacept | All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial. |
|
|
| 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. | All subjects started the trial on open label abatacept, so only one group is being analyzed for this 24 week outcome. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 receive 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Open Label Abatacept | Abatacept: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |