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Takayasu ArteritisPhase 3CommittedTANCT03096275

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

A Phase 3 study testing MMF, CYC and Glucocorticoids in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Takayasu Arteritis
What is being tested?
MMF, CYC and Glucocorticoids
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
7 sitesChina
Study dates
16 Mar 2017to 11 Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Beijing Xuanwu Hospital

    Beijing, 100053

  • the Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Hebei Provincial Hospital

    Shijiazhuang, Hebei, 050051

  • General Hospital of Tianjing Medical University

    Tianjin, 300052

  • Xijing Hospital

    Xian, Shanxi, 710032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
MMF, CYC, Glucocorticoids, MTX, AZA
Keywords
Mycophenolate mofetil, Methotrexate, cyclophosphamide
Medical subject headings
Takayasu Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MMFDrug

    Also called Guangwei

    Patients were treated with Glucocorticoids combined with methotrexate and mycophenolate mofetil

  • CYCDrug

    Also called huanlinxianan

    Patients were treated with Glucocorticoids and cyclophosphamide sequentially with azathioprine

  • GlucocorticoidsDrug

    Also called qiangdisong

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

  • MTXDrug

    Also called jiaandieling

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

  • AZADrug

    Also called liuzuopiaoling

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

Study groups in NCT03096275
Study groupRoleWhat they receive
MMF+MTX+GlucocorticoidsExperimentalPatients were treated with Glucocorticoids combined with mycphenolate mofetil(MMF) as well as methotrexate(MTX) treatment for 52 weeks and were followed for 52 weeks.
Receives: Drug: MMF; Drug: Glucocorticoids; Drug: MTX
CYC/AZA+GlucocoticoidsActive comparatorPatients were treated with Glucocorticoids combined with cyclophosphamide(CYC)/azathioprine(AZA) for 52 weeks and were followed for 52 weeks
Receives: Drug: CYC; Drug: Glucocorticoids; Drug: AZA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with complete remission

    The proportion of patients who reached the pre-defined criteria of complete remission in both groups

    Measured: 52 weeks

Secondary outcomes (3)

  1. Proportion of patients with partial remission

    Proportion of patients who reached the pre-defined partial remission criteria of the disease

    Measured: 52 weeks

  2. Safety profile of MMF combined with MTX

    Proportion of adverse events in both treatment groups

    Measured: 52 weeks

  3. Rate of complications

    Proportion of patients with complications in both treatment group

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start16 Mar 2017
  3. Primary completion11 Nov 2022
  4. Study completion11 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients were randomly assigned to two treatment arms and were treated for 12 months.
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096275
Sponsor's protocol ID
PUMCHCSTAR-006
Acronym
CommittedTA
Status last verified
Apr 2021
First submitted
13 Mar 2017
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arend WP, Michel BA, Bloch DA, Hunder GG, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis. Arthritis Rheum. 1990 Aug;33(8):1129-34. doi: 10.1002/art.1780330811.

    PubMed 1975175

  • Goel R, Danda D, Mathew J, Edwin N. Mycophenolate mofetil in Takayasu's arteritis. Clin Rheumatol. 2010 Mar;29(3):329-32. doi: 10.1007/s10067-009-1333-6.

    PubMed 20054700

  • Shinjo SK, Pereira RM, Tizziani VA, Radu AS, Levy-Neto M. Mycophenolate mofetil reduces disease activity and steroid dosage in Takayasu arteritis. Clin Rheumatol. 2007 Nov;26(11):1871-5. doi: 10.1007/s10067-007-0596-z. Epub 2007 Feb 28.

    PubMed 17332971

  • Daina E, Schieppati A, Remuzzi G. Mycophenolate mofetil for the treatment of Takayasu arteritis: report of three cases. Ann Intern Med. 1999 Mar 2;130(5):422-6. doi: 10.7326/0003-4819-130-5-199903020-00013.

    PubMed 10068416

  • Ong LM, Hooi LS, Lim TO, Goh BL, Ahmad G, Ghazalli R, Teo SM, Wong HS, Tan SY, Shaariah W, Tan CC, Morad Z. Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis. Nephrology (Carlton). 2005 Oct;10(5):504-10. doi: 10.1111/j.1440-1797.2005.00444.x.

    PubMed 16221103

  • Li J, Yang Y, Zhao J, Li M, Tian X, Zeng X. The efficacy of Mycophenolate mofetil for the treatment of Chinese Takayasu's arteritis. Sci Rep. 2016 Dec 7;6:38687. doi: 10.1038/srep38687.

    PubMed 27924855

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MMF, CYC and Glucocorticoids in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with complete remission (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096275, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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