study into the efficacy of methotrexate in patients with polymyalgia rheumatica

Phase 1

• Conditions: Polymyalgia rheumatica (PMR); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002413-18-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-10
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

•PMR according to the 2012 EULAR/ACR classification criteria, diagnosed within the last 12 weeks. Mandatory criteria:
oan age > 50,
obilateral shoulder pain,
oelevated CRP/ESR (dependent on local testing procedure),
•Patients must score at least 4 points in the following 2012 EULAR/ACR criteria:
oMorning stiffness > 45 mins (2 points),
oabsence of (rheumatoid factor) RF or Anti-citrullinated protein antibodies (ACPA) (2 points),
ohip pain or limited range of motion (1 point),
oabsence of other joint involvement (1 point);
•Patients must be eligible for treatment with MTX or placebo and show a willingness to follow the study protocol as judged by treating rheumatologist;
•Signed written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

•Not being able to speak, read or write Dutch;
•PMR-related GC treatment prior to inclusion consisting of either:
oGC exposure for > 8 weeks;
oGC treatment with > 30 mg/day;
oNo 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 clinical trial of medicinal product
• Study Design: Not specified