Overview

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)