polymyalgia polymyalgia rheumatica
Conditions
Interventions
5.1 Investigational product/treatment
Patients will randomly be allocated into two arms with a 1:1 ratio. Patients
allocated to the treatment arm will receive oral Methotrexate 15 mg per week
for th
if
a patient does not respond after 4 weeks, prednisone can be raised further and
the patient will be excluded from the study.
If a patient flares for the first time, prednisone will be increased t
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • PMR according to the 2012 EULAR/ACR classification criteria, diagnosed within the last 12 weeks. Mandatory criteria: o an age > 50, o bilateral shoulder pain, o elevated CRP/ESR (dependent on local testing procedure), • Patients must score at least 4 points in the following 2012 EULAR/ACR criteria: o Morning stiffness > 45 mins (2 points), o absence of (rheumatoid factor) RF or Anti-citrullinated protein antibodies (ACPA) (2 points), o hip pain or limited range of motion (1 point), o absence 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.
Exclusion criteria
Exclusion criteria: • Not being able to speak, read or write Dutch; • PMR-related GC treatment prior to inclusion consisting of either: o GC exposure for > 8 weeks; o GC treatment with > 30 mg/day; o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is the proportion of PMR patients in GC-free remission in both treatments groups compared to each other at week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients in GC-free remission at week 32; 2. The time to GC-free remission and first relapse; 3. The GC cumulative dose at week 32 and 52; 4. The number of relapses or recurrences during follow up at week 32 and 52; 5. The proportion of patients that relapsed or had a recurrence during follow up at week 32 and 52; 6. The change in PMR-AS; 7. The change in: ESR, CRP, transition and PASS questions, VAS, EQ-5D, HAQ, and PROMIS-PF; 8. The frequency and types of GC-related adverse events during the study as measured by the Glucocorticoid Toxicity Index (GTI); 9. The frequency and types of GC- and MTX-related adverse events 10. The proportion of patients that require a MTX/placebo (dose) adjustment. | — |
Countries
Netherlands
Outcome results
None listed