Systemic sclerosis & Raynaud's
A randomised, parallel-group, double-blind, placebo-controlled phase 3 study to Determine the effectiveness of the type I interferon receptor antibody, Anifrolumab, In SYstemic sclerosis: DAISY study design and rationale
Study context
- Population
- Adults with limited or diffuse cutaneous active systemic sclerosis (SSc) meeting ACR/EULAR 2013 SSc criteria; stable-dose standard immunosuppressants (incl. MMF) permittedplanned
- Participants
- 306 adults
- Planned comparison
- Weekly subcutaneous anifrolumab vs placebo, on top of permitted stable standard immunosuppressants
- Primary endpoint
- Revised-Composite Response Index in SSc (CRISS)-25 response
- Follow-up
- Week 52
Methodological detailsphase 3, multinational, parallel-group, double-blind, placebo-controlled, 52-week open-label active treatment period, 12-week safety follow-up, Key secondary endpoints: change from baseline in FVC in SSc-ILD, and modified Rodnan Skin Score
- Phase 3
- Multinational
- Parallel-group
- Double-blind
- Placebo-controlled
- 52-week open-label active treatment period
- 12-week safety follow-up
- Key secondary endpoints: change from baseline in FVC in SSc-ILD, and modified Rodnan Skin Score
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A randomised, parallel-group, double-blind, placebo-controlled phase 3 study to Determine the effectiveness of the type I interferon receptor antibody, Anifrolumab, In SYstemic sclerosis: DAISY study design and rationale. Clin Exp Rheumatol. Published 14 August 2024. doi:10.
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