NCT05102448 Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis
| NCT ID | NCT05102448 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Takayasu Arteritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 76 participants in total. It began in 2021-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Lindi Jiang, Ph.D., M.D.
STUDY CHAIR
Department of Rheumatology in Zhongshan hospital, Fudan University
Frequently Asked Questions
Who can join the NCT05102448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Takayasu Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05102448 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05102448 currently recruiting?
Yes, NCT05102448 is actively recruiting participants. Contact the research team at zsh-rheum@hotmail.com for enrollment information.
Where is the NCT05102448 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05102448 clinical trial?
NCT05102448 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Lindi Jiang, Ph.D., M.D. at Department of Rheumatology in Zhongshan hospital, Fudan University. The trial plans to enroll 76 participants.