Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
Axial Spondylarthritis (ax-SpA) is an important cause of inflammatory back pain in young
adults. Janus kinase inhibitors (JAKi) has been approved for treatment of ax-SpA. Tofacitinib
and baricitinib are drugs from same family (JAKi). Baricitinib is relatively less expensive
than Tofacitinib.
The goal of this non-inferiority clinical trial is to learn about the efficacy of baricitinib
in refractory axial spondyloarthritis ( ax-SpA) and to compare its effect with that of
tofacitinib. The main questions it aims to answer are:
1. Is baricitinib 4 mg effective in refractory ax-SpA?
2. Is baricitinib non-inferior to tofacitinib in refractory ax-SpA? Participants (treatment
group, 92 patients) will be treated with baricitinib 2 mg twice daily for 12 weeks.
Ninety two patients getting tofacitinib 10 mg/day (comparison group) will be taken as
historical control from another study on the efficacy of tofacitinib in refractory
ax-SpA?
Phase:
Phase 2
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh