The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis
An erratum to this article was published (RMD Open, 19 Dec 2023 ↗)
Authors' conclusion
DAZ treatment for all dosage regimens significantly reduced DAS28-CRP at day 113 relative to PBO.
Study context
- Population
- Adults with moderate-to-severe active rheumatoid arthritis (RA), RF and/or ACPA positive, inadequate response to MTX, other csDMARDs or TNFi, no prior B-cell depleting agentsrandomised equally to five groups
- Participants
- 78 adults
- Comparison
- Four dosing regimens of IV dazodalibep vs placebo
- Primary endpoint
- Change from baseline in DAS28-CRP
- Follow-up
- Day 113
Methodological detailsphase II, double-blind, placebo-controlled, dosage optimisation, Participants followed through day 309
- Phase II
- Double-blind
- Placebo-controlled
- Dosage optimisation
- Participants followed through day 309
Primary result
As reported in the abstract
Change from baseline in DAS28-CRP (least squares means±SE)
Dazodalibep (DAZ)
−1.83 to −1.90
least squares mean · SE 0.28–0.27
PBO
−1.06
least squares mean · SE 0.26
P < 0.05
Further findings
DAS28-CRP reduction · day 309
- Significant reductions in DAS28-CRP observed for all DAZ groups
Safety
Adverse events · generally balanced
Serious adverse events
- Serious adverse events, deemed unrelated to study medication
- 4
Original publication
The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. RMD Open. Published 4 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →