Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Patients meeting the ASAS classification criteria for axial spondyloarthritis

• Patients fulfilling the definition of refractory axial spondyloarthritis

• Patients with ASDAS-CRP ≥ 2.1

Locations
Other Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University
RECRUITING
Dhaka
Contact Information
Primary
Samaresh Das, M B B S
sam.dmc67@gmail.com
+8801723224832
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 184
Treatments
Experimental: Baricitinib
Participants of 'Baricitinib' arm will be treated with tablet baricitinib 2 mg twice daily for 12 weeks
Active_comparator: Tofacitinib
Participants of 'Tofacininib' arm getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis
Sponsors
Collaborators: Healthcare Pharmaceuticals
Leads: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

This content was sourced from clinicaltrials.gov