Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

This study has been completed.
Sponsor:
Collaborator:
Childhood Arthritis and Rheumatology Research Alliance
Information provided by (Responsible Party):
Egla C. Rabinovich, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00589628
First received: December 27, 2007
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Chronic Uveitis
Drug: infliximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Effects of Infliximab on Uveitis Disease Activity. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.


Enrollment: 13
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
5mg/kg/dose of infliximab IV every 4 weeks for 9 doses
Drug: infliximab
5mg/kg/dose IV at 4 week intervals
Other Name: Remicade
Active Comparator: 2
10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.
Drug: infliximab
10mg/kg/dose IV at 4 week intervals
Other Name: Remicade

Detailed Description:

Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 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. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589628

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Egla C. Rabinovich
Childhood Arthritis and Rheumatology Research Alliance
Investigators
Principal Investigator: Egla Rabinovich, MD. MPH Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Egla C. Rabinovich, Associate Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00589628     History of Changes
Other Study ID Numbers: Pro00000057
Study First Received: December 27, 2007
Results First Received: February 21, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Childhood
Uveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Infliximab
Antibodies, Monoclonal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014