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Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

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ClinicalTrials.gov Identifier: NCT04299971
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.

Condition or disease Intervention/treatment Phase
Takayasu Arteritis Methotrexate Inhibition Treatment Drug: Methotrexate Tablets Drug: Tofacitinib tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Mild and moderate TAK patients were divided into two groups, with 38 cases for each group at the randomized ratio 1:1, prescribed with methotrexate (15mg.qw.po) and tofacitinib (5mg.bid.po) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated, the strategy would be maintained for another 24weeks, otherwise, the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint)
Masking: None (Open Label)
Masking Description: Randomized but open-label.
Primary Purpose: Treatment
Official Title: Randomized Open-label Study in Mild and Moderate Patients With Takayasu Arteritis Between Methotrexate and Tofacitinib Based on the ECTA Cohort.
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: methotrexate
This group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks.
Drug: Methotrexate Tablets

The methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).

After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead.

Other Name: methotrexate pills

Experimental: Tofacitinib
This group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks.
Drug: Tofacitinib tablet

The tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).

After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead.

Other Name: Xeljanz




Primary Outcome Measures :
  1. Disease remission at 24 weeks. [ Time Frame: 24 weeks ]
    comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 24th week follow-up;


Secondary Outcome Measures :
  1. Disease remission at 48 weeks. [ Time Frame: 48 weeks ]
    comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 48th week follow-up;

  2. Prednisone dose reduction at endpoint [ Time Frame: 24 weeks and 48 weeks. ]
    comparison of targeted prednisone usage between tofacitinib and methotrexate groups at the end of 24th and 48th week follow-up;

  3. disease relapse in the follow-up [ Time Frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. ]
    comparison of relapse between tofacitinib and methotrexate groups; (Relapse is defined as: (1) Major relapse: Major relapse Recurrence of active disease with either of the following: a. Clinical features of ischaemia* (including jaw claudication,visual symptoms, visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. (2) Minor relapse: Recurrence of active disease, not fulfilling the criteria for a major relapse. )

  4. Vascular progression in angiographic examination at 6 months and 12 months. [ Time Frame: 24 weeks and 48 weeks. ]
    comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between tofacitinib and methotrexate groups;

  5. Change of the quality of life with questionnaire SF-36 [ Time Frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. ]
    comparison of quality of life between tofacitinib and methotrexate groups with the 36-Item Short Form Health Survey questionnaire (SF-36) (Scores:0~100, lower score means more disability)

  6. Change of the quality of life with MOS-sleep scale [ Time Frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. ]
    comparison of quality of life between tofacitinib and methotrexate groups with the questionnaire of sleep scale from medical outcomes study (MOS-sleep scale) (Scores: 11-65, lower scores indicates more difficulty in sleep)

  7. Change of the quality of life with the Fatigue severity scale [ Time Frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. ]
    comparison of quality of life between tofacitinib and methotrexate groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue)



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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age≥14 years;
  2. active status: Kerr score≥ 2;
  3. mild and moderate:

    1. Blood pressure (maximum) < 180/110mmHg;
    2. 1-2 branches with the stenotic rate < 70% involved;
    3. mildly ischemic manifestation relative to activity but relieve after rest;
    4. no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min;

Exclusion Criteria:

  1. Severe organ insufficiency;
  2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
  3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
  4. malignant tumors;
  5. history of severe drug allergy;
  6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)

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): NCT04299971


Contacts
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Contact: Rongyi Chen, PhD +86-15221160538 chenry825@hotmail.com
Contact: Lili Ma, PhD +86-15221160538 ma.lili1@zs-hospital.sh.cn

Locations
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China
Lindi Jiang Recruiting
Shanghai, China, 200032
Contact: Lindi Jiang, PhD    +86-021-64041990    zsh-rheum@hotmail.com   
Contact: Rongyi Chen, PhD    +86-15221160538    chenry825@hotmail.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Lindi Jiang, PhD Fudan University
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04299971    
Other Study ID Numbers: TACTIC-MM
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shanghai Zhongshan Hospital:
Takayasu arteritis
methotrexate
tofacitinib
treatment
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Methotrexate
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors