CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled
Drug / intervention
Mycophenolate mofetil +2 moredrug
Likely dose
Mycophenolate mofetil 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01829295
NCT01829295Phase 3Completed
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First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

University of California, San Francisco·interventional·Posted Apr 11, 2013·Updated Apr 2, 2024

In Brief

A Phase 3 clinical trial evaluating Mycophenolate mofetil, Methotrexate, and 1 other intervention for Uveitis. Completed, enrolled 216 participants across 9 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUveitis
CountriesAustralia, India, Mexico, Saudi Arabia, United States
CollaboratorsAravind Eye Hospitals, India, Oregon Health and Science University, Asociación para Evitar la Ceguera en México, Royal Victoria Eye and Ear Hospital, Northwestern University, National Eye Institute (NEI), King Khaled Eye Specialist Hospital

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2013
Enrollment StartAug 1, 2013
Primary CompletionFeb 21, 2018
Study CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.2 years ago

Interventions

Mycophenolate mofetildrug

For the first two weeks, an introductory dose of 500 mg twice a day (BID) orally. After two weeks, the dose will be increased to 1.5 g BID.

Methotrexatedrug

For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)

Prednisonedrug

All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.