Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Methotrexate; Tofacitinib

Criteria

Inclusion Criteria:

1. age≥14 years;

2. active status: Kerr score≥ 2;

3. mild and moderate:

1. Blood pressure (maximum) < 180/110mmHg;

2. 1-2 branches with the stenotic rate < 70% involved;

3. mildly ischemic manifestation relative to activity but relieve after rest;

4. no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min;

Exclusion Criteria:

1. Severe organ insufficiency;

2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;

3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;

4. malignant tumors;

5. history of severe drug allergy;

6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)