A Clinical Trial of Infliximab for Childhood Uveitis

NCT ID: NCT04150770

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2022-12-31

Brief Summary

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

Detailed Description

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, and the off-label use of infliximab, its potential risks and benefits. This is a prospective non-comparative interventional study.

Participants will receive intravitreal injections of suggested dose of infliximab (5 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.

Conditions

Uveitis; Infliximab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Childhood Uveitis

5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks

Group Type: EXPERIMENTAL

infliximab

Intervention Type: DRUG

Interventions

infliximab

Intervention Type: DRUG

Other Intervention Names

Remicade

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.
• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaomin Zhang

OTHER

Sponsor Role: lead

Responsible Party

Xiaomin Zhang

Principal Investigator, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaomin Zhang, M.D.

Role: STUDY_DIRECTOR

Tianjin Medical University Eye Hospital

Other Identifiers

2017KY-05

Identifier Type: -

Identifier Source: org_study_id