Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Chronic Uveitis
About this trial
This is an interventional treatment trial for Chronic Uveitis focused on measuring Childhood, Uveitis
Eligibility Criteria
Inclusion Criteria:. Ages 4 to 18 years old, Non-infectious uveitis Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications. Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine. Ability to provide informed consent (subject or parent/guardian) Onset of uveitis < 16 years of age. Topical ophthalmologic treatments allowed. Systemic corticosteroid use at entry may be allowed. Willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion. Concomitant methotrexate must be taken at time of initiation of infliximab Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination. Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab The screening laboratory test results must meet the following criteria: WBC (white blood cell count): within normal range for institution ANC (absolute neutrophil count): within normal range for institution Hemoglobin: greater than 10 grams/deciliter Platelets: within normal range for institution Serum Creatinine: within normal range for age AST - aspartate aminotransferase - within normal range for institution ALT - alanine aminotransferase- within normal range for institution Exclusion Criteria: Previous use of biologic medications for uveitis. Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months. Uveitis due to trauma or intraocular surgery Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion. Males who plan on fathering a child within 6 months after their last infliximab infusion. A history of a known allergy to murine products. Documentation of seropositivity for human immunodeficiency virus (HIV). Documentation of a positive test for hepatitis B surface antigen or hepatitis C A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months. An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. A concomitant diagnosis or history of congestive heart failure. A history of lymphoproliferative disease. Any known malignancy or a history of malignancy. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer. Presence of a transplanted solid organ.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
5mg/kg/dose of infliximab IV every 4 weeks for 9 doses
10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.