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Rheumatoid ArthritisPhase 2NCT02254655

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

A Phase 2 study testing Puerarin injection 400 mg in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital.

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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Puerarin injection 400 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
No sites listed yet
Study dates
Nov 2013to Nov 2017
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial

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.

Read the 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
Being tested
Puerarin injection 400 mg, Control
Keywords
puerarin, rheumatoid arthritis, atherosclerosis, carotid intima-media thickness
Medical subject headings
Arthritis, Rheumatoid, Atherosclerosis

What participants receive

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

  • Puerarin injection 400 mgDrug

    Also called Puerarin injection 400 mg + routine anti-rheumatic drugs

    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.

  • ControlDrug

    Also called Routine anti-rheumatic drugs

    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

Study groups in NCT02254655
Study groupRoleWhat they receive
Puerarin injection 400 mgExperimentalPatients 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.
Receives: Drug: Puerarin injection 400 mg
ControlSham comparatorPatients 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.
Receives: Drug: Control

What is being measured

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

  1. 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.

    Measured: At 0 week, 12 weeks, 24 weeks

Secondary outcomes (11)

  1. low-density lipoprotein cholesterol (LDL-C)

    Measured: at 0 week, 12 weeks, 24 weeks

  2. erythrocyte sedimentation rate (ESR)

    Measured: at 0 week, 12 weeks, 24 weeks

  3. C reactive protein (CRP)

    Measured: at 0 week, 12 weeks, 24 weeks

  4. Total cholesterol (TC)

    Measured: at 0 week, 12 weeks, 24 weeks

  5. triglycerides (TGs)

    Measured: at 0 week, 12 weeks, 24 weeks

  6. tumor necrosis factor (TNFα)

    Measured: at 0 week，12 weeks, 24 weeks

  7. interleukin-8 (IL-8)

    Measured: at 0 week，12 weeks, 24 weeks

  8. interleukin-1 (IL-1)

    Measured: at 0 week，12 weeks, 24 weeks

  9. interleukin-6 (IL-6)

    Measured: at 0 week，12 weeks, 24 weeks

  10. disease activity score in 28 joints (DAS28)

    Measured: at 0 week，12 weeks, 24 weeks

  11. homeostasis model assessment (HOMA-IR)

    Measured: at 0 week，12 weeks, 24 weeks

Timeline

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

  1. First posted2 Oct 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionSep 2017
  4. Study completionNov 2017

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254655
Sponsor's protocol ID
E-2012-063
Other IDs
No. BWS11J067
Status last verified
Jan 2018
First submitted
18 Nov 2013
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30245282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Puerarin injection 400 mg in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital.

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 7 inclusion and 4 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Changes from baseline in Carotid intima-media thickness at 24 weeks (time frame: At 0 week, 12 weeks, 24 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 NCT02254655, which also lists 1 linked publication.

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 17 Jan 2018.

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