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Investigator discretion due to lack of efficacy in three subjects enrolled
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients receiving apremilast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | oral dose of 30 mg BID for 6 months |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment | 7 months |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Patient receiving apremilast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
patients with refractory uveitis
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Patient receiving apremilast. |
| 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 | Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye | Posted | 6 months |
|
|
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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 | Treatment | Patient receiving apremilast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders |
Study was terminated prematurely due to inefficacy in the three initial patients enrolled. Endpoints were not analyzed as participants did not make it to the 6 month time frame before discontinuing the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Suhler | Oregon Health & Science University | 503-494-5023 | suhlere@ohsu.edu |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% | Posted | 6 months |
|
|
| 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) | Posted | 6 months |
|
|
| Primary | Reduction in Cystoid Macular Edema | Posted | 6 months |
|
|
| Secondary | Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment | Posted | 7 months |
|
|
| 0 |
| 3 |
| 1 |
| 3 |
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