Study on the efficacy of rituximab in patients with polymyalgia rheumatica

The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica - BRIDGE-PMR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002641-11-NL

Enrollment

Registered

2018-07-26

Start date

2018-11-21

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polymyalgia rheumatica

Interventions

Trade Name: rixathon Product Name: rixathon Product Code: L01X C02 Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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; Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies; Determining the frequency and types of GC-related adverse events during the study by using the GTI Determining the frequency and types of GC- and RTX-related adverse events during the study ;Primary end point(s): The proportion of PMR patients in GC-free remission.;Timepoint(s) of evaluation of this end point: 20 weeks	—

Measure

Time frame

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; Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies; Determining the frequency and types of GC-related adverse events during the study by using the GTI Determining the frequency and types of GC- and RTX-related adverse events during the study ;Primary end point(s): The proportion of PMR patients in GC-free remission.;Timepoint(s) of evaluation of this end point: 20 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): -GC cumulative dose -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; -Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies; -The frequency and types of GC-related adverse events during the study measured using the GTI; -The frequency and types of GC- and RTX-related adverse events during the study. ;Timepoint(s) of evaluation of this end point: 20 weeks	—

Measure

Time frame

Secondary end point(s): -GC cumulative dose -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; -Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies; -The frequency and types of GC-related adverse events during the study measured using the GTI; -The frequency and types of GC- and RTX-related adverse events during the study. ;Timepoint(s) of evaluation of this end point: 20 weeks

—

Countries

Netherlands

Contacts

Public ContactPrincipal investigator

Sint Maartenskliniek

a.vandermaas@maartenskliniek.nl+310243659985

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026