Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

Phase 3

Recruiting

Conditions: Polymyalgia Rheumatica
10003816
10023213

Registration Number: NL-OMON53470

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 174

Inclusion Criteria

• Polymyalgia rheumatica diagnosis fullfilling the 2012 EULAR/ACR
classification criteria
• Re-emerging PMR symptoms and elevated ESR or CRP levels
• Unable to reduce glucocorticoid dose below 5mg/day prednisolone or
equivalent.

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 diseases;
• concomitant conditions that might significantly interfere with PMR pain or
movement evaluation as judged by the investigator;
• previous hypersensitivity for RTX or contra-indications to RTX.

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>