Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis (NCT01603355) | Clinical Trial Compass
TerminatedPhase 1/2
Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis
Stopped: insufficient enrollment
United States3 participantsStarted 2013-11
Plain-language summary
The investigators are doing this research study to see if tocilizumab (Actemra) is safe and effective when used for severe or refractory non-infectious uveitis. Uveitis is an inflammation of the eye that is caused by the body's immune system reacting against the eye tissues.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with Juvenile Idiopathic Arthritis
* Subjects with vision-threatening autoimmune uveitis.
* Failure to respond to methotrexate or at least one other systemic immunosuppressive or intolerance to such medications due to side effects. Failure to respond includes presence of one plus or greater anterior chamber cell in both eyes; need for topical corticosteroid four times or more in either eye; ocular hypertension or glaucoma attributable to the topical corticosteroid.
* Subjects with bilateral disease.
* If subjects are on oral corticosteroids, the dosage must be stable for 2 weeks prior to baseline and not exceed 10 mg per day or 2mg/kg/day (whichever is less) of prednisone or its equivalent. Subjects must be willing to agree to not alter the dosage of oral steroids during the first 16 weeks of the trial.
* Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.
* Parent or guardian must understand and voluntarily sign an informed consent form.
* Pediatric subjects of either gender 2-17 years at time of consent.
Exclusion Criteria:
* Inability of parent or guardian to provide voluntary consent
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 12 months following randomization.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the stud…
What they're measuring
1
Number of Participants With Control of Ocular Inflammation