A Clinical Trial of Infliximab for Childhood Uveitis

NCT04150770 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2017KY-05
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Uveitis; Infliximab

Outcome Measures

Primary Outcomes (1)

• Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.

  Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.

  24 weeks

Secondary Outcomes (2)

• Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit.

  24 weeks

• Change in Vitreous Haze (VH) Grade From Baseline to Each Visit.

  24 weeks

Study Arms (1)

Patients with Childhood Uveitis

EXPERIMENTAL

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

Drug: infliximab

Interventions

infliximab DRUG

Also known as: Remicade

Patients with Childhood Uveitis

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaomin Zhang: lead

MeSH Terms

Conditions

Uveitis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaomin Zhang, M.D.

  Tianjin Medical University Eye Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: November 5, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2022
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share