Retrospective Comparison of the Efficacy of Methotrexate and Azathioprine as Background Treatment for Uveitis of Undetermined Origin: Single-centre Retrospective Study From 2005 to 2020
UMetAza
1 other identifier
observational
70
1 country
1
Brief Summary
Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 7, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMay 11, 2022
February 1, 2022
6 months
May 7, 2022
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effectiveness of methotrexate versus azathioprine in controlling the inflammation of intermediate, posterior and panuveitis of undetermined origin.
The main evaluation criterion will be the 12-month treatment effectiveness characterized by: * No recurrence of inflammation in both eyes as assessed by the patient's referring ophthalmologist * Oral corticosteroids \<7.5 mg equivalent-prednisone * No re-establishment of local corticosteroid therapy \> or = at 2 drop/d * No treatment stop due to intolerance or adverse reaction.
one year
Eligibility Criteria
Patients with uveitis (intermediate, posterior or panuveitis) of undetermined origin diagnosed and or followed between January 2005 and March 2020 at the CHRU of Brest and who received treatment with methotrexate or azathioprine.
You may qualify if:
- Patient age\>18 years
- Intermediate, posterior or panuveitis diagnosed clinically by an ophthalmologist.
- Patient treated with azathioprine or methotrexate
You may not qualify if:
- Patient under legal protection
- Methotrexate dose \< 10mg or azathioprine \< 50mg
- Systemic or ophthalmological disease (Behçet, sarcoidosis, Retinopathy of Birdshot, etc.)
- Infectious uveitis
- Ophthalmological surgery \< 30 days
- Delayed corticosteroid ocular implant \> 3 months
- Introduction of biotherapy simultaneously or prior to immunosuppressive treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Brest
Brest, 29609, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2022
First Posted
May 11, 2022
Study Start
May 1, 2022
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
May 11, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication