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

Sponsor
Sint Maartenskliniek
Study ID
NCT05533164
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    1000mg rituximab in 250ml NaCl 0.9% intravenously
  • Placebo — DRUG
    Placebo in 250ml NaCl 0.9% intravenously

Study Details

Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.

Key Dates

Start date
Feb 9, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    1000mg rituximab intravenously once
  • Placebo Comparator: Placebo
    0mg rituximab (placebo) intravenously once

Primary Outcome Measure

Between group difference in percentage of patients in glucocorticoid-free remission [ Time Frame: At week 52 ]

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