Actively Recruiting
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
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-15
76
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and safety of two treatments, tofacitinib and methotrexate, in patients with Takayasu's arteritis, a chronic inflammation of large blood vessels including the aorta and its branches. Current treatments with glucocorticoids and immunosuppressants often do not fully control the disease or prevent relapses, so this study seeks to find better options. The trial is a randomized controlled study sponsored by Shanghai Zhongshan Hospital focusing on active phase patients aged 18 to 65 years. Participants will be randomly assigned to receive either tofacitinib tablets (5 mg twice daily) or methotrexate tablets (15 mg once weekly), both for 12 months. Both groups will also receive prednisone with an initial dose and a tapering schedule based on disease activity. The prednisone dose starts high and is gradually reduced over 12 months if patients meet criteria for inactive disease, following specific tapering steps during the first and second half of the year. During the study, participants will be monitored regularly to assess treatment effectiveness, remission rates, relapse-free survival, glucocorticoid dosage, and side effects over 12 months. The primary outcome is the effectiveness rate after 6 months of treatment. Safety and other secondary outcomes will also be tracked. The study involves clinical evaluations, laboratory tests, and disease activity assessments to measure how well the treatments work and their safety.
CONDITIONS
Brief Title
Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients meet 1990 or 2018 American College of Rheumatology classification criteria for Takayasu arteritis
- Women or men aged 18 to 65 years
- Agree to avoid pregnancy during the trial with negative pregnancy test results for women
- Have active Takayasu arteritis according to NIH disease activity criteria
- Agree to sign informed consent
You will not qualify if you...
- Have organ failure such as New York class 4 heart function, low glomerular filtration rate (≤ 60 ml/min), liver dysfunction (Child grade 2 or above), high-frequency melanoma attacks, recent stroke, or high blood pressure (>160/100 mmHg)
- Had revascularization surgery related to Takayasu arteritis within 3 months or balloon dilation/surgery unrelated to TAK within 1 month
- Have other autoimmune diseases like ANCA-associated vasculitis, lupus, or Behcet's disease
- Have severe or uncontrolled comorbidities of kidney, liver, blood, gastrointestinal, lung, heart, or other conditions posing risks
- Have diseases requiring medium to high doses of glucocorticoids (prednisone ≥10 mg/day) during the study
- Have active infections such as hepatitis B or C, tuberculosis, or other serious infections
- Have malignancies
- Have abnormal lab tests including high liver enzymes, low white blood cells or platelets, or low hemoglobin
- Are allergic to the study drugs
- Previously failed to respond to tofacitinib or methotrexate after 3 months of treatment in medical history
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either tofacitinib or methotrexate along with prednisone therapy to treat active Takayasu's arteritis. Prednisone dosage is tapered based on disease activity over the treatment period.
Weekly visits during the initial phase with tapering assessments over the first 6 months, then visits every 4 weeks until 12 months
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.
X
Xiufang Kong, Ph.D., M.D.
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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