Spondyloarthritis & psoriatic arthritis
When Usual Care Is Not So Usual: Protocol Violations and Generalizability in a Treat‐to‐Target Strategy Trial in Patients With Axial Spondyloarthritis
Authors' conclusion
Protocol violations in the treat-to-target arm in the TICOSPA trial were frequent, although they did not have an impact on the rate of the primary outcome.
Study context
- Population
- Patients with axial spondyloarthritis (axSpA) fulfilling the ASAS criteria, ASDAS >2.1, bDMARD naive; 18 axSpA expert centres
- Participants
- 160 patients18 centres
- Comparison
- Treat-to-target prespecified management strategy (4-week visits) vs usual care at the rheumatologist's discretion (12-week visits)
- Treat to targetn = 80
- Usual care (UC)n = 80reference
Methodological detailscluster-randomized, controlled, 48-week
- Cluster-randomized
- Controlled
- 48-week
Primary result
As reported in the abstract
- Treat-to-target patients who violated the protocol at least once
- 51.2%
- Violations resulting in maintenance/reduction of treatment against protocol
- 62.2%
Further findings
ASAS-HI improvement, treat-to-target violators vs nonviolators · 48 weeks
- Similar ratios of ASAS-HI improvement
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
When Usual Care Is Not So Usual: Protocol Violations and Generalizability in a Treat‐to‐Target Strategy Trial in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). Published 14 July 2024. doi:10.
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