REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

Phase 3

Recruiting

Conditions: 10023213
Polymyalgia rheumatica
10003816

Registration Number: NL-OMON53492

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 114

Inclusion Criteria

• Newly diagnosed PMR (<12 weeks) according to the 2012 EULAR/ACR
classification criteria. • Glucocorticoid treatment <= 8 weeks • Glucocorticoid
dose equivalent of prednisolone <=30 mg/day.

Exclusion Criteria

• Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide
and azathioprine) 3 months prior to inclusion
• (clinical) suspect concomitant giant cell arteritis or other rheumatic
inflammatory disease
• Concomitant conditions that might significantly interfere with evaluation of
PMR pain or movement as judged by the investigator
• Previous hypersensitivity for RTX of contra-indications to RTX
• Not being able to speak, read or write Dutch

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the proportion of patients in GC free remission one year<br /><br>after RTX treatment compared to placebo. Remission will be defined as a<br /><br>polymyalgia rheumatica -activity score (PMR-AS) of <10.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include between group difference in proportion of<br /><br>patients in GC-free remission at week 21, the proportion of patients with low<br /><br>dose GC (<=5mg/day) remission at week 21 and 52, difference in PMR-AS, the<br /><br>number of disease relapses/recurrences at week 52, time to GC-free remission<br /><br>and to relapse, GC cumulative dose during the trial, and the proportion of<br /><br>patients with RTX/PCB retreatment, sex differences in frequencies of<br /><br>GC-remission and safety, change in Patient Reported Outcomes (PROMs), the<br /><br>frequency and types of GC- and RTX-related AE, change in the modified<br /><br>Glucocorticoid Toxicity Index (GTI) and cost-effectiveness. </p><br>