Methotrexate and Mycophenolate Mofetil for UVEITIS

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.

Conditions

• Uveitis

Interventions

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.

Sponsors & Collaborators

• Aravind Eye Hospitals, India

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Asociación para Evitar la Ceguera en México

  collaborator OTHER

• Royal Victoria Eye and Ear Hospital

  collaborator OTHER_GOV

• Northwestern University

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• King Khaled Eye Specialist Hospital

  collaborator OTHER_GOV

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Nisha Acharya, MD, MS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2018-02-21

Completion

2018-08-09

FDA Drug

Yes

Countries

• United States
• Australia
• India
• Mexico
• Saudi Arabia

Study Locations