Optimism in inclusion body myositis: a double-blind randomised controlled phase III trial investigating the effect of sirolimus on disease progression in patients with inclusion body myositis (IBM) as measured by the IBM Functional Rating Scale
Study context
- Population
- Patients with IBMplanned
- Participants
- 140 patients
- Planned comparison
- Sirolimus 2 mg vs matching placebo
- Primary endpoint
- Mean change in patient function on the IBM Functional Rating Scale (IBM-FRS)
- Follow-up
- Baseline to Week 84
Methodological detailsphase IIb/III, double-blind, placebo-controlled, equal allocation, international, Protocol version 3.0 (02-Dec-2022); ethical approval in Australia and the USA, European approval pending
- Phase IIb/III
- Double-blind
- Placebo-controlled
- Equal allocation
- International
- Protocol version 3.0 (02-Dec-2022); ethical approval in Australia and the USA, European approval pending
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Optimism in inclusion body myositis: a double-blind randomised controlled phase III trial investigating the effect of sirolimus on disease progression in patients with IBM as measured by the IBM Functional Rating Scale. Clin Exp Rheumatol. Published 26 February 2025. doi:10.
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