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

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ClinicalTrials.gov Identifier: NCT03096275
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
gwcmc
Information provided by (Responsible Party):
Xinping Tian, gwcmc

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.

Condition or disease Intervention/treatment Phase
Takayasu Arteritis Drug: MMF Drug: CYC Drug: Glucocorticoids Drug: MTX Drug: AZA Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly assigned to two treatment arms and were treated for 12 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's Arteritis
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018


Arm Intervention/treatment
Experimental: MMF+MTX+Glucocorticoids
Patients were treated with Glucocorticoids combined with mycphenolate mofetil(MMF) as well as methotrexate(MTX) treatment for 52 weeks and were followed for 52 weeks.
Drug: MMF
Patients were treated with Glucocorticoids combined with methotrexate and mycophenolate mofetil
Other Name: Guangwei

Drug: Glucocorticoids
Patients in the experimental group and comparator group were treated with Glucocorticoids and then gradually tapered
Other Name: qiangdisong

Drug: MTX
Patients in the experimental group are treated with Glucocorticoids combined with MTX and MMF
Other Name: jiaandieling

Active Comparator: CYC/AZA+Glucocoticoids
Patients were treated with Glucocorticoids combined with cyclophosphamide(CYC)/azathioprine(AZA) for 52 weeks and were followed for 52 weeks
Drug: CYC
Patients were treated with Glucocorticoids and cyclophosphamide sequentially with azathioprine
Other Name: huanlinxianan

Drug: Glucocorticoids
Patients in the experimental group and comparator group were treated with Glucocorticoids and then gradually tapered
Other Name: qiangdisong

Drug: AZA
Patients in the active comparator group were treated with Glucocorticoids combined with CYC followed by AZA
Other Name: liuzuopiaoling




Primary Outcome Measures :
  1. Proportion of patients with complete remission [ Time Frame: 52 weeks ]
    The proportion of patients who reached the pre-defined criteria of complete remission in both groups


Secondary Outcome Measures :
  1. Proportion of patients with partial remission [ Time Frame: 52 weeks ]
    Proportion of patients who reached the pre-defined partial remission criteria of the disease

  2. Safety profile of MMF combined with MTX [ Time Frame: 52 weeks ]
    Proportion of adverse events in both treatment groups

  3. Rate of complications [ Time Frame: 52 weeks ]
    Proportion of patients with complications in both treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096275


Contacts
Contact: Jing Li, MD 86-10-69158795 lijing_pumch2004@hotmail.com
Contact: Ai Xu, RN 86-13717958936 1989xuai@sina.cn

Locations
China, Hebei
Hebei Provincial Hospital Not yet recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Fengxiao Zhang, MD    13722879168    fengxiao.zhang@cstar.org.cn   
Contact: Wei Lin, MD    17736909239    linwei272@163.com   
China, Inner Mongolia
the Affiliated Hospital of Inner Mongolia Medical University Not yet recruiting
Huhehaote, Inner Mongolia, China, 010050
Contact: Hongbin Li, MD    13948536552    hongbin.li@cstar.org.cn   
Contact: Ning Tie, MD    13948610720    tieting@126.com   
China, Shanxi
Xijing Hospital Not yet recruiting
Xian, Shanxi, China, 710032
Contact: Zhenbiao Wu, MD    13700235112    ping.zhu@cstar.org.cn   
Contact: Weitong Chen, MD    15771943030    chenweitong0818@163.com   
China
Beijing Chaoyang Hospital Not yet recruiting
Beijing, China, 100020
Contact: Yi Zheng, MD    13911170090    yi.zheng@cstar.org.cn   
Contact: Yongfeng Zhang, MD    13671239495    zyf760116@sina.com   
Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Contact: Xinping Tian, MD    86-13691165939    tianxp6@126.com   
Contact: Shi Rong, MD    86-13601248311    rongshipumch@126.com   
Sub-Investigator: XInping Tian, MD         
Beijing Xuanwu Hospital Not yet recruiting
Beijing, China, 100053
Contact: Xiaoxia Li, MD    13501164945    xiaoxia.li@cstar.org.cn   
Contact: Yi Zhao, MD    13811038669    zhaoyi_peking@163.com   
General Hospital of Tianjing Medical University Not yet recruiting
Tianjin, China, 300052
Contact: Wei Wei, MD    13920182411    wei.wei@cstar.org.cn   
Contact: Na Zhang, MD    13820489562    lunazhang22@hotmail.com   
Sponsors and Collaborators
Chinese SLE Treatment And Research Group
gwcmc
Investigators
Principal Investigator: Xinping Tian, MD gwcmc

Publications of Results:
Other Publications:
Responsible Party: Xinping Tian, Professor of Medicine, gwcmc
ClinicalTrials.gov Identifier: NCT03096275     History of Changes
Other Study ID Numbers: PUMCHCSTAR-006
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinping Tian, gwcmc:
Mycophenolate mofetil
Methotrexate
cyclophosphamide

Additional relevant MeSH terms:
Glucocorticoids
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Cyclophosphamide
Methotrexate
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists