Study on the efficacy of rituximab in patients with polymyalgia rheumatica

Phase 1

• Conditions: polymyalgia rheumatica; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-002641-11-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-26
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

·PMR according to the ACR/EULAR 2012 PMR core classification criteria
·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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

·Not being able to speak, read or write Dutch
·PMR diagnosed >4 weeks before inclusion in the study
·Exposure to GC or other immunosuppressant treatments in the past 3 months
·Known concomitant GCA or other rheumatic diseases such as RA, spondylarthropathies, connective tissue diseases, drug-induced myopathies, active and untreated thyroid disorders, Parkinson disorder or fibromyalgia
·Previous hypersensitivity for prednisone, RTX or murine peptides
·Contra-indications to RTX such as active current infection, including hepatitis B or tuberculosis infection, state of severe immunodeficiency, severe heart failure (NYHA-class IV)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determining the GC-sparing effect of RTX by assessing the proportion of PMR patients with GC-free remission and GC cumulative dose after 20 weeks;Secondary Objective: Assessing the effect of 1* 1000 mg RTX on disease activity in PMR patients by determining the change of ESR and CRP, PMR-AS, inner core domain set as proposed by the OMERACT, SF-36, EQ5D-5L, HAQ-DI from baseline to 20 weeks;<br>Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies;<br>Determining the frequency and types of GC-related adverse events during the study by using the GTI<br>Determining the frequency and types of GC- and RTX-related adverse events during the study<br>;Primary end point(s): The proportion of PMR patients in GC-free remission.;Timepoint(s) of evaluation of this end point: 20 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -GC cumulative dose<br>-The change of ESR and CRP, PMR-AS, inner core domain set as proposed by the OMERACT, SF-36, EQ5D-5L, HAQ-DI from baseline to 20 weeks;<br>-Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies; <br>-The frequency and types of GC-related adverse events during the study measured using the GTI;<br>-The frequency and types of GC- and RTX-related adverse events during the study.<br>;Timepoint(s) of evaluation of this end point: 20 weeks