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

Phase 1

• Conditions: Polymyalgia rheumatica; MedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2022-003128-42-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-20
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• A clinical diagnoses of PMR according to the 2012 EULAR/ACR classification criteria.
• Re-emerging PMR symptoms and elevated ESR of CRP levels.
• Glucocorticoid dose equivalent of prednisolone = 5mg/day.

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 174
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 174

Exclusion Criteria

• Treatment with systemic immunosuppressants (other than GC) 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 clinical trial of medicinal product
• Study Design: Not specified