Methotrexate and Mycophenolate Mofetil for UVEITIS

PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

February 21, 2018

Study Completion Date

August 9, 2018

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.

Trial Locations (9)

3002

Royal Victorian Eye and Ear Hospital, Melbourne

60611

Northwestern University, Chicago

94143

Francis I Proctor Foundation, San Francisco

97239

Oregon Health and Science University - Casey Eye Institute, Portland

Unknown

Aravind Eye Hospital, Coimbatore

Aravind Eye Hospital, Madurai

Aravind Eye Hospital, Pondicherry

King Khaled Eye Specialist Hospital, Riyadh

04030

Asociacion Para Evita La Ceguera en Mexico, Mexico City

All Listed Sponsors
collaborator

Aravind Eye Hospitals, India

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

Asociación para Evitar la Ceguera en México

OTHER

collaborator

Royal Victoria Eye and Ear Hospital

OTHER_GOV

collaborator

Northwestern University

OTHER

collaborator

National Eye Institute (NEI)

NIH

collaborator

King Khaled Eye Specialist Hospital

OTHER_GOV

lead

University of California, San Francisco

OTHER

NCT01829295 - Methotrexate and Mycophenolate Mofetil for UVEITIS | Biotech Hunter | Biotech Hunter