Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Information source: Duke University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Uveitis
Intervention: infliximab (Drug); infliximab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Egla C. Rabinovich Official(s) and/or principal investigator(s): Egla Rabinovich, MD. MPH, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effects of Infliximab on Uveitis Disease Activity.
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
Minimum age: 4 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Research Information. Click on current studies
Related publications: Heiligenhaus A, Foeldvari I, Edelsten C, Smith JR, Saurenmann RK, Bodaghi B, de Boer J, Graham E, Anton J, Kotaniemi K, Mackensen F, Minden K, Nielsen S, Rabinovich EC, Ramanan AV, Strand V; Multinational Interdisciplinary Working Group for Uveitis in Childhood. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: a consensus effort from the multinational interdisciplinary working group for uveitis in childhood. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1365-72. doi: 10.1002/acr.21674. Review. Ardoin SP, Kredich D, Rabinovich E, Schanberg LE, Jaffe GJ. Infliximab to treat chronic noninfectious uveitis in children: retrospective case series with long-term follow-up. Am J Ophthalmol. 2007 Dec;144(6):844-849. Epub 2007 Oct 22.
Starting date: September 2007
Last updated: August 22, 2013
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