NCT01829295

Methotrexate and Mycophenolate Mofetil for UVEITIS

First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized comparative effectiveness trial to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as first-line corticosteroid-sparing treatment for patients with non-infectious intermediate, posterior and panuveitis requiring corticosteroid-sparing therapy. The primary outcome is treatment success assessed at the 6 month visit (Phase 1, 0-6 months). If patients are a treatment success, they continue on the medication for another 6 months (Phase 1, 6-12 months). Patients who are a treatment failure can crossover to the other medication (Phase 2, 0-6 months).

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil	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.
DRUG	Methotrexate	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)
DRUG	Prednisone	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-02-21
• Completion: 2018-08-09
• First posted: 2013-04-11
• Last updated: 2024-04-02
• Results posted: 2019-04-26

Locations

9 sites across 5 countries: United States, Australia, India, Mexico, Saudi Arabia

Regulatory

• FDA-regulated drug study