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

NCT02254655 | Completed Phase 2 DMC

• 2 other identifiers: E-2012-063No. BWS11J067
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

puerarin; rheumatoid arthritis; atherosclerosis; carotid intima-media thickness

Outcome Measures

Primary Outcomes (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.

  At 0 week, 12 weeks, 24 weeks

Secondary Outcomes (11)

• low-density lipoprotein cholesterol (LDL-C)

  at 0 week, 12 weeks, 24 weeks

• erythrocyte sedimentation rate (ESR)

  at 0 week, 12 weeks, 24 weeks

• C reactive protein (CRP)

  at 0 week, 12 weeks, 24 weeks

• Total cholesterol (TC)

  at 0 week, 12 weeks, 24 weeks

• triglycerides (TGs)

  at 0 week, 12 weeks, 24 weeks

Other Outcomes (3)

• Kidney function

  at 0 week, 12 weeks, 24 weeks

• Liver function

  at 0 week, 12 weeks, 24 weeks

• blood cell count

  at 0 week, 12 weeks, 24 weeks

Study Arms (2)

Puerarin injection 400 mg

EXPERIMENTAL

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.

Drug: Puerarin injection 400 mg

Control

SHAM COMPARATOR

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.

Drug: Control

Interventions

Puerarin injection 400 mg DRUG

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.

Also known as: Puerarin injection 400 mg + routine anti-rheumatic drugs

Puerarin injection 400 mg

Control DRUG

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

Also known as: Routine anti-rheumatic drugs

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu PLA General Hospital: lead

Related Publications (1)

• 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.

  PMID: 30245282 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Atherosclerosis

Interventions

puerarin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Yang, Ph.D.

  General Hospital of Chengdu Military Area Command PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: October 2, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01