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

4139

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

2022-01-01

2024-03-01

2024-03-01

Completed

Early phase I

92

Inclusion Criteria: 1. Age ≥18 years 2. Patient fulfill the ASAS classification criteria for ax-SpA 3. Patient fulfill the definition of refractory axial ax-SpA 4. Patients with ASDAS-CRP\>2.1 Exclusion Criteria: 1. Patient currently taking or had prior treatment with bDMARD or tsDMARD (including JAK inhibitor) 2. Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis (including tuberculosis) 3. Hemoglobin (Hb) \< 9 g/dl 4. White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3 5. Live vaccines within 3 months prior to the first dose 6. GFR less than 50 mL/min 7. Alanine aminotransaminase (ALT) more than 2 times of ULN 8. Pregnant or breast feeding females of child-bearing potential not using highly effective contraception 9. Evidence or history of malignancy 10. New York Heart Association Class III and IV congestive heart failure 11. Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Dose escalation study, all the patients will recieve 10mg tofacitinib at the beginning. Then at 3rd month, one group will continue at 10mg, if they fulfill the ASDAS major improvement criteria and other group will escalate to 15mg.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

2024-03-13