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Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

NCT06707194 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Spondyloarthritis (SpA)
  • Ankylosing Spondylitis (AS)

Interventions

BIOLOGICAL

Etanercept

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

DRUG

Benzathine 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

OTHER

Placebo

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-14
Primary Completion
2027-03-01
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06707194 on ClinicalTrials.gov