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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Maartenskliniek Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

1 Feb 2023 → 29 Oct 2025

Decision date (initial)

2024-11-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513544-28-00

EudraCT number

2022-003127-18

ClinicalTrials.gov

NCT05533125

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective is to study the efficacy of treatment with rituximab in patients with newly diagnosed polymyalgia rheumatica compared to placebo

Conditions and MedDRA coding

Polymyalgia Rheumatica

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients with newly diagnosed PMR (<12 weeks) according to the 2012 EULAR/ACR classification criteria
2. Glucocorticoid treatment <8 weeks
3. Glucocorticoid dose equivalent of prednisolone <30mg/day

Exclusion criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of patients in glucocorticoid free remission one year after RTX treatment compared to placebo.

Secondary endpoints 21

1. Proportion of patients in GC free remission at week 21.
2. Proportion of patients with low dose GC (≤5mg/day) remission at week 21, week 52, 1.5 and 2 years
3. PMR-AS at each visit.
4. number of disease relapses/recurrences up to week 52.
5. proportion of patients with a disease relapse/recurrence at week 52.
6. The time from baseline to GC free remission and to relapse.
7. GC cumulative dose at 52 weeks, 1.5 and 2 years.
8. Proportion of patients with RTX/PCB retreatment.
9. Proportion of patients who start methotrexate, leflunomide, tocilizumab or sarilumab or possible other bDMARD being registered for PMR
10. Sex differences in frequencies of GC-remission and adverse events
11. Changes in patient reported outcomes, concerning pain, fatigue, stiffness and physical function
12. Medical consumption and productivity loss.
13. (Changes in) modified glucocorticoid toxicity index (which excludes bone mineral density scan to improve feasibility).
14. Frequency, types, proportion of patients with and total numbers of (especially GC- and RTX-related) AE during the 52 week study.
15. Proportion of patients in GC free remission 1.5 years after RTX/PCB infusion
16. Proportion of patients in GC free remission 2 years after RTX/PCB infusion
17. The number of disease relapses/recurrences up to 2 years.
18. The proportion of patients with a disease relapse/recurrence at 2 years.
19. The proportion of patients lost-to follow-up and the reason for loss to follow-up at 1.5 and 2 years
20. The proportion of patients that had a (different) DMARD started (and reason for starting the DMARD) at 1.5 and 2 years
21. The proportion (and number) of patients in which a (concomitant) rheumatic (inflammatory) disease was diagnosed at 1.5 and 2 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek Stichting

Sponsor organisation

Sint Maartenskliniek Stichting

Address

Hengstdal 3

City

Ubbergen

Postcode

6574 NA

Country

Netherlands

Scientific contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Aatke van der Maas

Public contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Aatke van der Maas

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications