Status:
UNKNOWN
Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborating Sponsors:
Healthcare Pharmaceuticals
Conditions:
Spondyloarthritis, Axial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
This clinical trial will be conducted in the department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka from October 2023-March 2025. A total of 184 patients of both gender...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients who are currently on treatment or had been previously treated with bDMARDs or tsDMARDS (including JAK inhibitors)
- Hemoglobin \< 9 gm/dl
- WBC count \< 4000/cmm, Neutrophil count \< 1000 cmm, Platelet count \< 100000/cmm
- Any current or previous history of serious opportunistic infection including tuberculosis
- Live vaccine within 3 months prior to the first dose
- GFR \< 50 ml/min
- ALT \> 2 times upper limit normal
- Pregnancy, breastfeeding or women of reproductive age group not using effective contraceptive
- Current or previous history of malignancy, lymphoproliferative disease
- New York Heart Association Class III and IV congestive heart failure
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06114407
Start Date
October 30 2023
End Date
December 30 2024
Last Update
December 21 2023
Active Locations (1)
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1
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000