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Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's Arteritis

NCT03096275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-08-30

No results posted yet for this study

Summary

Takayasu's arteritis(TAK) is a rare systemic vasculitis which can cause ischemia or inflammation of the involved organs and increase the overall mortality rate.The traditional treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK are glucocorticosteroids(GC) and immunosuppressants. However, the genital toxicity of CYC has limited its long term use. In a pilot study carried out by the principal investigator of this study has shown that mycophenolate mofetil(MMF) combined with MTX is effective and with few adverse effects. The purpose of this prospective open-label study is to compare the efficacy and safety of GC+MMF+MTX with GC+CYC followed by GC+AZA for the treatment of active TAK. 150 patients with active TAK will be recruited and randomized in a 2:1 ratio to GC+MMF+MTX group and C+CYC and AZA group. Patients were followed for 52 weeks for efficacy and safety assessment.

Conditions

  • Takayasu Arteritis

Interventions

DRUG

MMF

Patients were treated with Glucocorticoids combined with methotrexate and mycophenolate mofetil

DRUG

CYC

Patients were treated with Glucocorticoids and cyclophosphamide sequentially with azathioprine

DRUG

Glucocorticoids

Patients in the experimental group and comparator group were treated with Glucocorticoids and then gradually tapered

DRUG

MTX

Patients in the experimental group are treated with Glucocorticoids combined with MTX and MMF

DRUG

AZA

Patients in the active comparator group were treated with Glucocorticoids combined with CYC followed by AZA

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Xinping Tian, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2022-11-11
Completion
2022-11-11

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT03096275 on ClinicalTrials.gov