NCT06310057CompletedPhase 4
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Source: ClinicalTrials.gov · Last updated 13 Mar 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 8 Mar 2024
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06310057
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 92
- From 1 Jan 2022 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient currently taking or had prior treatment with bDMARD or tsDMARD (including JAK inhibitor)
- Live vaccines within 3 months prior to the first dose
Other illness
- Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis (including tuberculosis)
- Evidence or history of malignancy
- New York Heart Association Class III and IV congestive heart failure
- Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
Lab values
- Hemoglobin (Hb) \< 9 g/dl
- White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3
- GFR less than 50 mL/min
- Alanine aminotransaminase (ALT) more than 2 times of ULN
Other
- Pregnant or breast feeding females of child-bearing potential not using highly effective contraception
Who the study is looking for
- Age ≥18 years
- Patient fulfill the ASAS classification criteria for ax-SpA
- Patient fulfill the definition of refractory axial ax-SpA
- Patients with ASDAS-CRP\>2.1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.