Trial Outcomes & Findings for Abatacept in the Treatment of Uveitis (NCT NCT01279954)

NCT ID: NCT01279954

Last Updated: 2019-02-21

Results Overview

number of participants with adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	5	5
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	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.	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.
Overall Study Lack of Efficacy	3	4

Baseline Characteristics

Abatacept in the Treatment of Uveitis

Baseline characteristics by cohort

Measure	Open-label Abatacept, Then 10 mg/kg Abatacept n=5 Participants 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.	Open-label Abatacept, Then 5 mg/kg Abatacept n=5 Participants 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.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Ocular Inflammation	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

number of participants with adverse events

Outcome measures

Measure	Randomized 10 mg/kg Abatacept n=2 Participants 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 continue receiving 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.	Randomized 5 mg/kg Abatacept n=2 Participants 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.	Open Label Abatacept n=10 Participants All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial.
Adverse Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: All subjects started the trial on open label abatacept, so only one group is being analyzed for this 24 week outcome.

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.

Outcome measures

Measure	Randomized 10 mg/kg Abatacept n=10 Participants 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 continue receiving 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.	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.	Open Label Abatacept All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial.
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Randomized 10 mg/kg Abatacept n=8 Participants 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 continue receiving 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.	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.	Open Label Abatacept All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial.
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%	6 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Randomized 10 mg/kg Abatacept n=9 Participants 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 continue receiving 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.	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.	Open Label Abatacept All subjects received open label 10mg/kg abatacept during the first 24 weeks of the trial.
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods	4 Participants	—	—

Adverse Events

10 mg/kg Abatacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

5 mg/kg Abatacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Label Abatacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Suler, MD

Oregon Health & Science University

Phone: 503-494-5023

Email: suhlere@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place