Abatacept in the Treatment of Uveitis
Primary Purpose
Uveitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
Eligibility Criteria
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
open-label abatacept first, then 5 mg/kg abatacept
open-label abatacept first, then 10 mg/kg abatacept
Arm Description
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
Outcomes
Primary Outcome Measures
Adverse Events
number of participants with adverse events
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01279954
First Posted
January 14, 2011
Last Updated
January 30, 2019
Sponsor
Oregon Health and Science University
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01279954
Brief Title
Abatacept in the Treatment of Uveitis
Official Title
An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open-label abatacept first, then 5 mg/kg abatacept
Arm Type
Experimental
Arm Description
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
Arm Title
open-label abatacept first, then 10 mg/kg abatacept
Arm Type
Experimental
Arm Description
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
orencia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
number of participants with adverse events
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity
Description
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
Title
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Description
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
Title
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric B. Suhler, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James T Rosenbaum, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
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Abatacept in the Treatment of Uveitis
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