The efficacy of Methotrexate for glucocorticoid dose reduction in recently diagnosed polymyalgia rheumatica patients: a double-blind randomized placebo controlled multicenter clinical trial.

Phase 3

Completed

Conditions: polymyalgia
polymyalgia rheumatica
10003816

Registration Number: NL-OMON54851

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the proportion of PMR patients in GC-free<br /><br>remission in both treatments groups compared to each other at week 52. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The proportion of patients in GC-free remission at week 32;<br /><br>2. The time to GC-free remission and first relapse;<br /><br>3. The GC cumulative dose at week 32 and 52;<br /><br>4. The number of relapses or recurrences during follow up at week 32 and 52;<br /><br>5. The proportion of patients that relapsed or had a recurrence during follow<br /><br>up at week 32 and 52;<br /><br>6. The change in PMR-AS;<br /><br>7. The change in: ESR, CRP, transition and PASS questions, VAS, EQ-5D, HAQ, and<br /><br>PROMIS-PF;<br /><br>8. The frequency and types of GC-related adverse events during the study as<br /><br>measured by the Glucocorticoid Toxicity Index (GTI);<br /><br>9. The frequency and types of GC- and MTX-related adverse events<br /><br>10. The proportion of patients that require a MTX/placebo (dose) adjustment. </p><br>