Methotrexate and Mycophenolate Mofetil for UVEITIS

Completed · Phase 3

Conditions studied: Uveitis

In brief

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.

Key facts

Study ID: NCT01829295
Run by: University of California, San Francisco
People needed: 216
Starts: 2013-08-01
Expected to finish: 2018-08-09
Last updated by the study team: 2024-04-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 corticosteroid-sparing immunosuppressive treatment: Behcet's disease with posterior segment involvement, multifocal choroiditis with panuveitis, serpiginous choroidopathy, birdshot retinochoroidopathy, diffuse retinal vasculitis, Vogt-Koyanagi-Harada with bullous serous retinal detachments and/or choroidal detachments, sympathetic ophthalmia. No prior therapy required for these patients
Willingness to start corticosteroid treatment at 1mg/kg or 60mg a day of prednisone, whichever is less
Willingness to limit alcohol consumption
Willingness to use an acceptable method of contraception during the study period (i.e. pharmacologic medications, devices, barrier methods) or abstinence.
Exclusion Criteria: Any of the following
Any infectious cause of uveitis
Prior immunosuppressive therapy other than corticosteroids in the past 12 months
Prior intolerability or safety issues with methotrexate or mycophenolate mofetil
Prior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil
Prior biologic therapy at any time

Where it is running

Francis I Proctor Foundation — San Francisco, California, United States
Northwestern University — Chicago, Illinois, United States
Oregon Health and Science University - Casey Eye Institute — Portland, Oregon, United States
Royal Victorian Eye and Ear Hospital — Melbourne, Victoria, Australia
Aravind Eye Hospital — Coimbatore, Tamil Nadu, India
Aravind Eye Hospital — Madurai, Tamil Nadu, India
Aravind Eye Hospital — Pondicherry, Tamil Nadu, India
Asociacion Para Evita La Ceguera en Mexico — Mexico City, Mexico City, Mexico
King Khaled Eye Specialist Hospital — Riyadh, Saudi Arabia

Full record on ClinicalTrials.gov

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