Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant responses will be measured at at four to eight week intervals for up to ten months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis|
- Effects of Infliximab on Uveitis Disease Activity. [ Time Frame: 9 months ] [ Designated as safety issue: No ]Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.
|Study Start Date:||September 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
5mg/kg/dose of infliximab IV every 4 weeks for 9 doses
5mg/kg/dose IV at 4 week intervals
Other Name: Remicade
Active Comparator: 2
10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.
10mg/kg/dose IV at 4 week intervals
Other Name: Remicade
Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589628
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Egla Rabinovich, MD. MPH||Duke University|