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Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study

NCT06310057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-03-13

No results posted yet for this study

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

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

Tofacitinib

Tofacitinib (JAKi) is a targeted therapy option for patients with refractory ax-SpA.

Sponsors & Collaborators

  • Incepta Pharmaceuticals Ltd

    collaborator INDUSTRY

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Drug
Yes

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310057 on ClinicalTrials.gov