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RECRUITING

NCT05102448

PHASE4

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate and compare the efficacy and safety of tofacitinib and methotrexate based on prednisone therapy in patients with Takayasu arteritis

Official title: Comparison of the Efficacy and Safety of Tofacitinib and Methotrexate Based on Prednisone Therapy in Patients with Active Phase of Takayasu's Arteritis: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-11-01

Completion Date

2025-12-31

Last Updated

2024-10-15

Healthy Volunteers

Conditions

Takayasu Arteritis

Interventions

DRUG

Tofacitinib

1. Tofacitinib 5mg twice a day for 12 months; 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.

DRUG

Methotrexate

1. Methotrexate (15mg each week) for 12 months 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.

Inclusion Criteria: 1. Patients met 1990 American College of Rheumatology (ACR) classification criteria or 2018 ACR classification criteria (draft) of TAK 2. Women or men aged 18-65 3. All patients agreed that there is no fertility plan during clinical trials, and the results of female serum or urinary pregnancy tests must be negative 4. Active TAK patients according to NIH disease activity criteria 5. All patients agreed to sign the informed consent Exclusion Criteria: 1. Patients with organ failure who accord to one or more of the following conditions: I.Heart function New York class 4 II.Glomerular filtration rate ≤ 60ml/min III.Liver function Child grade 2 and above IV.High-frequency melanoma (attacks for 3 consecutive days) V.Acute cerebral infarction or cerebral hemorrhage VI.Blood pressure \> 160/100mmHg 2. Patients who received revascularization surgery related to the treatment of TAK within 3 months (except balloon dilatation); balloon dilatation or surgery unrelated to TAK within 1 month 3. Patients who have other autoimmune diseases (e.g. ANCA-associated vasculitis, systemic lupus erythematosus, Behcet's disease, etc.) 4. Patients with severe, progressive or uncontrolled comorbidities of kidney, liver, blood system, gastrointestinal, lung, heart, etc or other coexisting medical conditions that may exert unexpected risks 5. Patients with concomitant diseases, such as asthma, that may require additional medium to high doses of glucocorticoids (prednisone ≥ 10mg/ days or equivalent dose) during the study period 6. Patients with active infections with HBV, HCV, tuberculosis or other serious acute or chronic infections 7. Patients with malignancies 8. Patients with one or more of the following abnormal laboratory examinations I.Serum ALT or AST ≥ 1.5 times the normal upper limit; II.White blood cell count ≤ 4 × 109/L III.Platelet count ≤ 100x109/L IV.Hemoglobin \< 85g/L V.Other abnormal laboratory tests that may cause unacceptable risks 9. Patients allergic to the experimental drug 10. Patients who have ever failed to tofacitinib or methotrexate after 3 months' treatment in previous medical history

Locations (1)

Lindi Jiang

Shanghai, Shanghai Municipality, China