Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Condition: Chronic Uveitis
MeSH terms: Uveitis
Intervention: infliximab; infliximab
Intervention description: 5mg/kg/dose IV at 4 week intervals; 10mg/kg/dose IV at 4 week intervals
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Childhood; Uveitis

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:.

          1. Ages 4 to 18 years old,

          2. Non-infectious uveitis

          3. Persistent uveitis uncontrolled by topical medications, or unacceptable side effects
             of topical medications.

          4. Failure of at least six weeks of treatment with a non-biological disease modifying
             agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.

          5. Ability to provide informed consent (subject or parent/guardian)

          6. Onset of uveitis < 16 years of age.

          7. Topical ophthalmologic treatments allowed.

          8. Systemic corticosteroid use at entry may be allowed.

          9. Willingness to use acceptable contraception if sexually active for the duration of the
             study and for 6 months after receiving the last infliximab infusion.

         10. Concomitant methotrexate must be taken at time of initiation of infliximab

         11. Participant must be able to cooperate for a non-sedated slit lamp exam and visual
             acuity examination.

         12. Negative Purified Protein Derivative (PPD) placed and read within 1 month of
             initiation of infliximab

         13. 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:

          1. Previous use of biologic medications for uveitis.

          2. Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.

          3. Uveitis due to trauma or intraocular surgery

          4. Females who are pregnant, nursing, or planning pregnancy within 6 months after the
             last infliximab infusion.

          5. Males who plan on fathering a child within 6 months after their last infliximab
             infusion.

          6. A history of a known allergy to murine products.

          7. Documentation of seropositivity for human immunodeficiency virus (HIV).

          8. Documentation of a positive test for hepatitis B surface antigen or hepatitis C

          9. A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis)
             in the previous 3 months.

         10. An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus,
             Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB)
             within 6 months prior to screening.

         11. A concomitant diagnosis or history of congestive heart failure.

         12. A history of lymphoproliferative disease.

         13. Any known malignancy or a history of malignancy.

         14. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
             hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
             disease.

         15. 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.

         16. Presence of a transplanted solid organ.