RecruitingPhase 4NCT06707194

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

340 participants

Start Date

Jun 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.


Eligibility

Min Age: 18 YearsMax Age: 59 Years

Inclusion Criteria1

  • The following patients would be included: (1) The subjects voluntarily participate and sign an informed consent form; (2) patients aged 18-59 years; (3) According to the following guidelines or diagnostic criteria, a standardized diagnosis of spinal arthritis patients is made, which meets one of the following diagnostic criteria: ① 2009 ASAS classification criteria for axial spinal arthritis; ② Classification criteria for ASAS peripheral spondyloarthritis in 2011. And subjects with spinal arthritis who are in a relatively active period (ASDAS-CRP\>1.2 )of infection;

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Interventions

BIOLOGICALEtanercept

Prefilled syringe, 25mg of hypodermic injection, twice a week

DRUGBenzathine Penicillin

Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, 1.2 million units of intramuscular injection, once every two weeks

OTHERPlacebo

Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, intramuscular injection, once every two weeks


Locations(6)

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Nan Fang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Nan Fang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

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NCT06707194


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