Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

NCT00589628 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00000057
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Uveitis

Keywords

Childhood; Uveitis

Outcome Measures

Primary Outcomes (1)

• Effects of Infliximab on Uveitis Disease Activity.

  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.

  9 months

Study Arms (2)

1

ACTIVE COMPARATOR

5mg/kg/dose of infliximab IV every 4 weeks for 9 doses

Drug: infliximab

2

ACTIVE COMPARATOR

10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.

Drug: infliximab

Interventions

infliximab DRUG

5mg/kg/dose IV at 4 week intervals

Also known as: Remicade

1

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.
• Willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion.
• Concomitant methotrexate must be taken at time of initiation of infliximab
• 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

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
• Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion.
• Males who plan on fathering a child within 6 months after their last infliximab infusion.
• 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.

Sponsors & Collaborators

• Egla C. Rabinovich: lead
• Childhood Arthritis and Rheumatology Research Alliance: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

• 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.

  PMID: 22438273 BACKGROUND

• 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. doi: 10.1016/j.ajo.2007.08.018. Epub 2007 Oct 22.

  PMID: 17953940 BACKGROUND

• Saurenmann RK, Levin AV, Rose JB, Parker S, Rabinovitch T, Tyrrell PN, Feldman BM, Laxer RM, Schneider R, Silverman ED. Tumour necrosis factor alpha inhibitors in the treatment of childhood uveitis. Rheumatology (Oxford). 2006 Aug;45(8):982-9. doi: 10.1093/rheumatology/kel030. Epub 2006 Feb 3.

  PMID: 16461435 RESULT

• Kahn P, Weiss M, Imundo LF, Levy DM. Favorable response to high-dose infliximab for refractory childhood uveitis. Ophthalmology. 2006 May;113(5):860-4.e2. doi: 10.1016/j.ophtha.2006.01.005. Epub 2006 Mar 20.

  PMID: 16545455 RESULT

• Rajaraman RT, Kimura Y, Li S, Haines K, Chu DS. Retrospective case review of pediatric patients with uveitis treated with infliximab. Ophthalmology. 2006 Feb;113(2):308-14. doi: 10.1016/j.ophtha.2005.09.037. Epub 2006 Jan 10.

  PMID: 16406545 RESULT

Related Links

• Research Information. Click on current studies

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

Limitations and Caveats

Study recruitment was difficult and slow. Optimal number not achieved in this descriptive study.

Results Point of Contact

• Title: Dr. C. Egla Rabinovich
• Organization: Duke Health Systems

egla.rabinovich@duke.edu

919-668-0238

Study Officials

• Egla Rabinovich, MD. MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 26, 2013
• Results First Posted: August 26, 2013

Record last verified: 2013-08

Locations

US (1)