Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03096275
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2017-03-13
Brief Title:
Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasus Arteritis
Sponsor:
Chinese SLE Treatment And Research Group
Organization:
Chinese SLE Treatment And Research Group
Study Overview
Official Title:
Comparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasus Arteritis
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CommittedTA
Brief Summary:
Takayasus arteritisTAK is a rare systemic vasculitis which can cause ischemia or inflammation of the involved organs and increase the overall mortality rateThe traditional treatment of TAK is primarily empirical The most commonly used drugs for treating active TAK are glucocorticosteroidsGC 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 mofetilMMF 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 GCMMFMTX with GCCYC followed by GCAZA for the treatment of active TAK 150 patients with active TAK will be recruited and randomized in a 21 ratio to GCMMFMTX group and CCYC and AZA group Patients were followed for 52 weeks for efficacy and safety assessment
Detailed Description:
Takayasus arteritisTAK is a rare systemic vasculitis which mainly involves aorta and its major branches Howeverit is more prevalent in countries and areas along the silk roadYoung women at child-bearing age is the most prevalent populationIt can cause ischemia or inflammation of the involved organs and increase the overall mortality rateAlthough it may be lethal in some patientsit is not well studied due to the rareness of the diseaseThe traditional treatment of TAK is primarily empirical The most commonly used drugs for treating active TAK are glucocorticosteroidsGC and immunosuppressants including cyclophosphamideCYC methotrexateMTX and azathioprineAZA etc Howeverno 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 toxicityespecially 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 mofetilMMF 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 GCMMFMTX with GCCYC followed by GCAZA for the treatment of active TAK 150 patients with active TAK will be recruited and randomized in a 21 ratio to GCMMFMTX group and CCYC and AZA group Patients were followed for 52 weeks to assess the efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None