A Clinical Trial of Infliximab for Childhood Uveitis

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood uveitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaomin Zhang
• Treatments: Infliximab

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.

• 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

• 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.