Trial intelligence / Profile preview

Puerarin injection for CIMT in Rheumatoid Arthritis

NCT02254655Phase 2

Key facts

Status: Completed
Start: Nov 2013
Primary completion: Sep 2017
Sponsor: General Hospital of Western Theater Command of PLA
Modality: Orthosteric Ligands

Drugs: puerarin
Conditions: rheumatoid arthritis (RA)

Overview

Phase 2, randomised, single-blind trial of puerarin in rheumatoid arthritis (RA) (2 arms), sponsored by General Hospital of Western Theater Command of PLA. Primary endpoint: Carotid intima-media thickness at 24 weeks. Started Nov 2013; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

Puerarin + Routine Care
Puerarin injection 400 mg IV daily (2 weeks on/15 days off) + Routine anti-rheumatic care
Routine Care
Routine anti-rheumatic care only

Who it enrols

Patients with definite RA diagnosis, aged 18-75. Excludes patients with hypertension, known carotid artery stenosis, severe hepatic or renal disorders, coagulation disorders, or pregnancy.

Endpoints

Primary

Carotid intima-media thickness24 weeks

Secondary

low-density lipoprotein cholesterol24 weeks
erythrocyte sedimentation rate24 weeks
C reactive protein24 weeks
Total cholesterol24 weeks
triglycerides24 weeks
tumor necrosis factor alpha24 weeks
interleukin-824 weeks
interleukin-124 weeks

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