Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Completed · Phase 4
Conditions studied: Chronic Uveitis
In brief
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.
Key facts
- Study ID
- NCT00589628
- Run by
- Egla C. Rabinovich
- People needed
- 13
- Starts
- 2007-09-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2013-08-26
Who can join
Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
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.
- Presence of a transplanted solid organ.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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