Uveitis
Conditions
Keywords
uveitis, apremilast
Brief summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
Interventions
DRUGApremilast
oral dose of 30 mg BID for 6 months
Sponsors
Celgene Corporation
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
* 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 * previous or current use of an alkylating agent * use of CYP3A4 inhibitors during the trial * TNF blocker use within the 8 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye | 6 months |
| Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% | 6 months |
| Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis) | 6 months |
| Reduction in Cystoid Macular Edema | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment | 7 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Patient receiving apremilast. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)
Time frame: 6 months
Primary
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Time frame: 6 months
Primary
Reduction in Cystoid Macular Edema
Time frame: 6 months
Primary
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Time frame: 6 months
Secondary
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
Time frame: 7 months