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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT03096275
• Date of registration: 13/03/2017
• Prospective Registration: Yes
• Primary sponsor: Chinese SLE Treatment And Research Group
• Public title: Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's Arteritis CommittedTA
• Scientific title: Comparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's Arteritis
• Date of first enrolment: March 16, 2017
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03096275
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Xinping Tian, MD
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Takayasu Arteritis

Intervention(s)

Drug: Glucocorticoids

Drug: MTX

Drug: MMF

Drug: AZA

Drug: CYC

Primary Outcome(s)

Proportion of patients with complete remission [Time Frame: 52 weeks]

Secondary Outcome(s)

Safety profile of MMF combined with MTX [Time Frame: 52 weeks]

Rate of complications [Time Frame: 52 weeks]

Proportion of patients with partial remission [Time Frame: 52 weeks]

Secondary ID(s)

PUMCHCSTAR-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Peking Union Medical College Hospital