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The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Puerarin injection 400 mg
Control
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring puerarin, rheumatoid arthritis, atherosclerosis, carotid intima-media thickness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
  • aged from 18 to 75 years
  • without conflict to the written, informed consent signed prior to the enrollment
  • no severe hepatic or renal disorders
  • no known carotid artery stenosis
  • no coagulation disorders
  • no hypertension

Exclusion Criteria:

  • being in pregnancy, lactation period or under a pregnancy plan
  • being allergic to the test drug
  • not compatible for the trial medication
  • without full legal capacity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Puerarin injection 400 mg

    Control

    Arm Description

    Patients were administrated with 400 mg intravenously infused puerarin injection once a day. Puerarin injection was prepared in 250 mL 0.9% sodium chloride injection before the use. The treatment course consisted of 2 weeks followed by a 15-day interval for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.

    Patients receive routine anti-rheumatic care only. Patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.

    Outcomes

    Primary Outcome Measures

    Changes from baseline in Carotid intima-media thickness at 24 weeks
    Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment.

    Secondary Outcome Measures

    low-density lipoprotein cholesterol (LDL-C)
    erythrocyte sedimentation rate (ESR)
    C reactive protein (CRP)
    Total cholesterol (TC)
    triglycerides (TGs)
    tumor necrosis factor (TNFα)
    interleukin-8 (IL-8)
    interleukin-1 (IL-1)
    interleukin-6 (IL-6)
    disease activity score in 28 joints (DAS28)
    homeostasis model assessment (HOMA-IR)

    Full Information

    First Posted
    November 18, 2013
    Last Updated
    January 15, 2018
    Sponsor
    Chengdu PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02254655
    Brief Title
    The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis
    Official Title
    The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chengdu PLA General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.
    Detailed Description
    Controlled, randomized trial RA patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection Assessments were made at entry, 12 and 24 weeks The overall sample size was assessed before the enrollment Randomization was performed using concealed random allocation method The collected data was processed and assessed by two reviewers All the measurement and analysis procedures concerning CIMT were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment The reproducibility of the ultrasonographic method was test before the trial

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    puerarin, rheumatoid arthritis, atherosclerosis, carotid intima-media thickness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    119 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Puerarin injection 400 mg
    Arm Type
    Experimental
    Arm Description
    Patients were administrated with 400 mg intravenously infused puerarin injection once a day. Puerarin injection was prepared in 250 mL 0.9% sodium chloride injection before the use. The treatment course consisted of 2 weeks followed by a 15-day interval for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Patients receive routine anti-rheumatic care only. Patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
    Intervention Type
    Drug
    Intervention Name(s)
    Puerarin injection 400 mg
    Other Intervention Name(s)
    Puerarin injection 400 mg + routine anti-rheumatic drugs
    Intervention Description
    Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.Furthermore, patients were administrated with 400 mg intravenously infused puerarin injection once a day.Each treatment course lasted for 2 weeks followed by a regular time interval of 15 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    Routine anti-rheumatic drugs
    Intervention Description
    Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis
    Primary Outcome Measure Information:
    Title
    Changes from baseline in Carotid intima-media thickness at 24 weeks
    Description
    Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment.
    Time Frame
    At 0 week, 12 weeks, 24 weeks
    Secondary Outcome Measure Information:
    Title
    low-density lipoprotein cholesterol (LDL-C)
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    erythrocyte sedimentation rate (ESR)
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    C reactive protein (CRP)
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    Total cholesterol (TC)
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    triglycerides (TGs)
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    tumor necrosis factor (TNFα)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Title
    interleukin-8 (IL-8)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Title
    interleukin-1 (IL-1)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Title
    interleukin-6 (IL-6)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Title
    disease activity score in 28 joints (DAS28)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Title
    homeostasis model assessment (HOMA-IR)
    Time Frame
    at 0 week，12 weeks, 24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Kidney function
    Description
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    Liver function
    Description
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
    Time Frame
    at 0 week, 12 weeks, 24 weeks
    Title
    blood cell count
    Description
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
    Time Frame
    at 0 week, 12 weeks, 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010 aged from 18 to 75 years without conflict to the written, informed consent signed prior to the enrollment no severe hepatic or renal disorders no known carotid artery stenosis no coagulation disorders no hypertension Exclusion Criteria: being in pregnancy, lactation period or under a pregnancy plan being allergic to the test drug not compatible for the trial medication without full legal capacity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Min Yang, Ph.D.
    Organizational Affiliation
    General Hospital of Chengdu Military Area Command PLA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30245282
    Citation
    Yang M, Luo Y, Liu T, Zhong X, Yan J, Huang Q, Tao J, He Q, Guo M, Hu Y. The Effect of Puerarin on Carotid Intima-media Thickness in Patients With Active Rheumatoid Arthritis: ARandomized Controlled Trial. Clin Ther. 2018 Oct;40(10):1752-1764.e1. doi: 10.1016/j.clinthera.2018.08.014. Epub 2018 Sep 21.
    Results Reference
    derived

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    The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

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