PolyMyalgia Rheumatica treatment with Methotrexate in Optimal Dose in an Early disease phase

Phase 3

Completed

• Conditions: 10003816; Methotrexate; <p>polymyalgia rheumatica (PMR) spierreuma</p>; Jylamvo

• Registration Number: NL-OMON22681
• Lead Sponsor: Sint Maartenskliniek Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- PMR according to the 2012 EULAR/ACR classification criteria - eligibility for treatment with MTX or placebo and show a willingness to follow the study protocol as judged by treating rheumatologist - Signed written informed consent

Exclusion Criteria

- Not being able to speak, read or write Dutch; - PMR-related GC treatment prior to inclusion consisting of either: GC exposure for > 8 weeks, GC treatment with > 30 mg/day, or No further information regarding GC treatment; - Exposure to other systemic immunosuppressant treatments other than GC 3 months prior to inclusion in the study; - Active concomitant GCA or other rheumatic diseases such as RA, spondylarthropathies, connective tissue diseases, or drug-induced myopathies; - Neuropathies or other conditions that might interfere with pain or movement evaluation of PMR, as judged by the treating rheumatologist; - Previous hypersensitivity for prednisolone or MTX.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The between group difference in proportion of PMR patients in GC-free remission at week 52.</p><br>