Overview

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

Status:
Recruiting

Trial end date:
2024-12-30

Target enrollment:
0

Participant gender:
All

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Collaborator:

Healthcare Pharmaceuticals

Treatments:

Tofacitinib

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Patients meeting the ASAS classification criteria for axial spondyloarthritis

3. Patients fulfilling the definition of refractory axial spondyloarthritis

4. Patients with ASDAS-CRP ≥ 2.1

Exclusion Criteria:

1. Patients who are currently on treatment or had been previously treated with bDMARDs or
tsDMARDS (including JAK inhibitors)

2. Hemoglobin < 9 gm/dl

3. WBC count < 4000/cmm, Neutrophil count < 1000 cmm, Platelet count < 100000/cmm

4. Any current or previous history of serious opportunistic infection including
tuberculosis

5. Live vaccine within 3 months prior to the first dose

6. GFR < 50 ml/min

7. ALT > 2 times upper limit normal

8. Pregnancy, breastfeeding or women of reproductive age group not using effective
contraceptive

9. Current or previous history of malignancy, lymphoproliferative disease

10. New York Heart Association Class III and IV congestive heart failure