Status:
COMPLETED
Methotrexate and Mycophenolate Mofetil for UVEITIS
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Aravind Eye Hospitals, India
Oregon Health and Science University
Conditions:
Uveitis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 m...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Media opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes
- Chronic hypotony (IOP \< 5 mm Hg for \> 3 months) in both eyes
- Periocular or intravitreal corticosteroid injection in the past 4 weeks
- Fluocinolone acetonide implant in either eye in \< 3 years
- Intraocular surgery in \< 30 days, or planning on getting surgery within the next 6 months
- Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye
- \< 16 years of age at enrollment
- Planning to conceive during the study period, pregnant or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal is mandatory)\*
- Any history of cancer (If a patient has a history of non-melanoma skin cancer they can still be considered for inclusion in this study, provided it is not currently active).
- Systemic autoimmune disease anticipated to dictate treatment course
- Abnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment\*
- Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment\*
- Evidence of active tuberculosis, HIV infection, syphilis, or hepatitis B or C (patients must have a tuberculin skin test, or interferon-gamma release assay, a chest radiograph, Rapid plasma reagin / Venereal disease research laboratory test (RPR/VDRL), fluorescent treponemal antibody absorption test (FTA-ABS), or other treponemal tests, Hepatitis B surface antigen, Hepatitis C antibody tests, and HIV test within 90 days prior to enrollment)\*\*
- \*Testing required within 4 weeks prior to enrollment; \*\*Testing required within 90 days prior to enrollment.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2018
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01829295
Start Date
August 1 2013
End Date
August 9 2018
Last Update
April 2 2024
Active Locations (9)
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1
Francis I Proctor Foundation
San Francisco, California, United States, 94143
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Oregon Health and Science University - Casey Eye Institute
Portland, Oregon, United States, 97239
4
Royal Victorian Eye and Ear Hospital
Melbourne, Victoria, Australia, 3002