Actively Recruiting
Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-15
76
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients meet the 1990 or 2018 American College of Rheumatology (ACR) classification criteria for Takayasu arteritis
- Women or men aged 18 to 65 years
- Agree to avoid pregnancy during the trial, with negative pregnancy tests for females
- Active Takayasu arteritis according to NIH disease activity criteria
- Agree to sign informed consent
You will not qualify if you...
- Organ failure including heart class 4, kidney filtration rate ≤ 60 ml/min, liver function Child grade 2 or above, frequent severe headaches, recent stroke or brain hemorrhage, or high blood pressure > 160/100 mmHg
- Revascularization surgery for Takayasu arteritis within 3 months (except balloon dilatation); balloon dilatation or other surgery unrelated to Takayasu arteritis within 1 month
- Presence of other autoimmune diseases such as ANCA-associated vasculitis, lupus, or Behcet's disease
- Severe, progressive, or uncontrolled comorbidities affecting kidney, liver, blood, gastrointestinal, lung, heart, or other systems
- Diseases requiring medium to high doses of glucocorticoids (prednisone ≥ 10 mg/day) during the study
- Active infections including hepatitis B or C, tuberculosis, or other serious infections
- Cancer
- Abnormal lab tests including liver enzymes ≥ 1.5 times normal, low white blood cells, low platelets, low hemoglobin, or other risky abnormalities
- Allergy to the study drugs
- Previous treatment failure with tofacitinib or methotrexate after at least 3 months of therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lindi Jiang
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
L
Lindi Jiang, Ph.D., M.D.
CONTACT
X
Xiufang Kong, Ph.D., M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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