Methotrexate and Mycophenolate Mofetil for UVEITIS (NCT01829295) | Clinical Trial Compass
CompletedPhase 3
Methotrexate and Mycophenolate Mofetil for UVEITIS
United States, Australia, India216 participantsStarted 2013-08
Plain-language summary
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.
Who can participate
Age range16 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:
* All the following criteria must be met at enrollment:
Historical non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye
Active inflammation within the last 180 days, defined by the presence of any of the following (in at least one eye) according to Standardization of Uveitis Nomenclature (SUN) criteria:
* ≥ 2+ anterior chamber cells
* ≥ 2+ vitreous haze
* active retinal or choroidal lesions
Active inflammation at enrollment, defined by the presence of any of the following (in at least one eye) according to SUN criteria:
* ≥1+ anterior chamber cells and/or
* ≥1+ vitreous haze and/or
* active retinal/choroidal lesions
At least one of the following criteria must be met before or at enrollment:
* Active inflammation after 4 weeks of high-dose (1mg/kg prednisone equivalent) corticosteroid treatment or 4 weeks following a regional corticosteroid injection
* Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by an increase in inflammation (of at least 1 grade in anterior chamber cells or vitreous haze or a change of non-active to active lesions) when corticosteroid is tapered, in the 180 weeks prior to enrollment
* Active inflammation after long-acting corticosteroid injection 4 weeks to 180 days prior to enrollment
* Active inflammation after treatment with \>10mg/day oral prednisone for at least the past 90 days prior to enrollment
* Known chronic condition necessitating …
What they're measuring
1
Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)