Uveitis
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.
Interventions
DRUGAdalimumab
40 mg delivered every 2 weeks by subcutaneous injection
Sponsors
University of Illinois at Chicago
The Cleveland Clinic
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with vision-threatening autoimmune uveitis. 2. Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.
Exclusion criteria
1. Serious concomitant illness that could interfere with the subject's participation in the trial. 2. Previous or current use of cyclophosphamide. 3. Unable or unwilling to undergo multiple injections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Endpoint | 10 weeks | Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age Continuous | 40.9 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Cumulative Endpoint
Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Cumulative Endpoint | 21 participants |
Primary
Cumulative Endpoint
Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.
Time frame: 50 Weeks
Population: Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Cumulative Endpoint | 12 participants |