drugset / Trial / NCT06310057
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Phase 4
Completed
92 enrolled
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Incepta Pharmaceuticals Ltd · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria. The main question\[s\] it aims to answer are: * Efficacy and safety of tofacitinib in different doses * If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg
Timeline
- Start
- 2022-01-01
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tofacitinib | Small molecule | 10 mg | — |
| Subject | Tofacitinib | Small molecule | 15 mg | — |