Comparing Tofacitinib and Methotrexate for Takayasu's Arteritis

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

This study is testing if tofacitinib works better than methotrexate for people with Takayasu's arteritis who are also taking prednisone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Drugs / interventions: tofacitinib, methotrexate, prednisone, cyclophosphamide
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05102448 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of tofacitinib compared to methotrexate in patients with Takayasu's arteritis who are also receiving prednisone therapy. Takayasu's arteritis is a chronic condition affecting large blood vessels, and current treatments have not been fully effective in achieving remission or preventing relapses. Tofacitinib, a Jak inhibitor, has shown promise in treating autoimmune diseases, and this trial seeks to confirm its effectiveness specifically for Takayasu's arteritis. The study will be conducted as a randomized controlled trial to provide robust data on the comparative outcomes of these two treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with active Takayasu's arteritis according to established classification criteria.

Not a fit: Patients with severe organ failure or those who have undergone specific surgical interventions related to Takayasu's arteritis within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from Takayasu's arteritis.

How similar studies have performed: While tofacitinib has shown promise in other autoimmune conditions, this specific comparison in Takayasu's arteritis is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Lindi Jiang — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lindi Jiang, Ph.D., M.D.

Conditions: Takayasu Arteritis