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

Comparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's Arteritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03096275

Acronym

CommittedTA

Enrollment

138

Registered

2017-03-30

Start date

2017-03-16

Completion date

2022-11-11

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takayasu Arteritis

Keywords

Mycophenolate mofetil, Methotrexate, cyclophosphamide

Brief 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.

Detailed description

Takayasu's arteritis(TAK) is a rare systemic vasculitis which mainly involves aorta and its major branches. However,it is more prevalent in countries and areas along the silk road.Young women at child-bearing age is the most prevalent population.It can cause ischemia or inflammation of the involved organs and increase the overall mortality rate.Although it may be lethal in some patients,it is not well studied due to the rareness of the disease.The traditional treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK are glucocorticosteroids(GC) and immunosuppressants including cyclophosphamide(CYC), methotrexate(MTX) and azathioprine(AZA) etc. However,no of these drugs have been well studied. In addition, the genital toxicity of CYC, the first line medication for active TAK, has become the major limitation for its long term use for a chronic disease like TAK. Therefore, new immunosuppressants with less toxicity,especially with much less genital toxicity and low malignancy risk is essentially necessary. 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 to assess the efficacy and safety.

Interventions

DRUGMMF

Patients were treated with Glucocorticoids combined with methotrexate and mycophenolate mofetil

DRUGCYC

Patients were treated with Glucocorticoids and cyclophosphamide sequentially with azathioprine

DRUGGlucocorticoids

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

DRUGMTX

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

DRUGAZA

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patients were randomly assigned to two treatment arms and were treated for 12 months.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients older than 18 years-old either sex 2. Patients with signed informed consent 3. Fulfill the 1990 ACR Classification Criteria for TAK 4. Patients with active disease according to GACTA criteria

Exclusion criteria

1. Prior adverse events when treated with MTX that resulted in dose reduction or discontinuation; 2. Prior treatment with MMF but failed response to MMF; 3. Prior treatment with CYC but failed response to CYC; 4. Renal dysfunction, defined as the estimated GFR \<80% or serum creatinine level higher than 1.5 times of upper normal limit; 5. Severe liver function damage defined by serum ALT or AST higher than 2 times of the upper normal limits; 6. Uncontrolled diabetes melitus; 7. Uncontrolled heart failure at baseline; 8. Active infection including tuberculosis , hepatitis B virus, hepatitis C virus, HIV or bacterial or fungal infection; 9. Active upper GI bleeding in the past 3 months.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with complete remission	52 weeks	The proportion of patients who reached the pre-defined criteria of complete remission in both groups

Secondary

Measure	Time frame	Description
Proportion of patients with partial remission	52 weeks	Proportion of patients who reached the pre-defined partial remission criteria of the disease
Safety profile of MMF combined with MTX	52 weeks	Proportion of adverse events in both treatment groups
Rate of complications	52 weeks	Proportion of patients with complications in both treatment group

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026