Comparing Baricitinib and Tofacitinib for Treating Refractory Axial Spondyloarthritis
Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib
This study is testing whether a medication called baricitinib can help people with tough-to-treat axial spondyloarthritis feel better compared to another medication called tofacitinib.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Drugs / interventions | Tofacitinib, baricitinib |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06114407 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of baricitinib in patients with refractory axial spondyloarthritis (ax-SpA) and compare its efficacy to tofacitinib. A total of 184 patients aged 18 and older will be enrolled, with 92 receiving baricitinib and 92 serving as historical controls receiving tofacitinib. The trial will assess disease activity using the ASDAS-CRP score over a 12-week period, with follow-up visits to monitor clinical outcomes and side effects. Baricitinib will be provided free of charge to participants, ensuring adherence through monthly pill counts.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with refractory axial spondyloarthritis and high disease activity.
Not a fit: Patients currently on or previously treated with biologic or targeted synthetic DMARDs may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more cost-effective treatment option for patients with refractory axial spondyloarthritis.
How similar studies have performed: Other studies have shown positive outcomes with JAK inhibitors in treating axial spondyloarthritis, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Samaresh Das, M B B S — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Samaresh Das, M B B S
- Email: sam.dmc67@gmail.com
- Phone: +8801723224832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.