Takayasu Arteritis Clinical Trial in China

NCT02981979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-04-24

No results posted yet for this study

Summary

To investigate the efficacy and safety of Leflunomide (LEF) versus placebo combined with prednisone for active Takayasu arteritis (TAK) in Chinese population.

Conditions

  • Takayasu Arteritis

Interventions

DRUG

Leflunomide(LEF)

Leflunomide: For LEF arm, 20mg per day, p.o. through the whole study. For placebo group, 20mg per day, p.o. from week 25 to week 52.

DRUG

Prednisone Acetate Tablets

Prednisone (5mg/tab): basic therapy, start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day.

DRUG

Placebos

2 tabs/d used in placebo arm for the first 24 weeks.

Sponsors & Collaborators

  • Jiang lindi

    lead OTHER

Principal Investigators

  • Lindi Jiang, Doctor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2022-05-22
Completion
2022-11-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981979 on ClinicalTrials.gov