Home › Trials › NCT06707194
Clinical trial Recruiting at 2 sites Phase 4 Interventional Ages 18 to 59

Benzathine penicillin plus etanercept for spondyloarthritis

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

Run by Nanfang Hospital, Southern Medical University · NCT06707194 · Data updated 2026-11-12

This trial will test whether adding benzathine penicillin to etanercept helps adults with spondyloarthritis reduce disease activity more than etanercept alone.

More Ankylosing Spondylitis (AS) trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 59 Years
SexAll
Enrollment340 (estimated)
SponsorNanfang Hospital, Southern Medical University
Academic / other
Locations6 sites (Hefei, Anhui and 5 other locations)
StatusRecruiting
StartedJune 14, 2025
Main results expectedMarch 1, 2027
Study endsJuly 31, 2027
Registry record updatedJune 26, 2025
Trial IDNCT06707194 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–59 years old with a confirmed diagnosis of axial or peripheral spondyloarthritis and active disease (ASDAS-CRP > 1.2) who can attend study visits and give informed consent.

Probably not a fit

Patients with active infections (including tuberculosis), inflammatory bowel disease, other systemic rheumatic or immune diseases, malignancy, severe liver or kidney dysfunction, or known allergy to study drugs are unlikely to be eligible or to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled, multicenter Phase 4 trial will enroll 340 adults with active spondyloarthritis and randomly assign them to benzathine penicillin plus etanercept or placebo plus etanercept for an initial 12-week blinded period. Treatments are given by injection and participants are followed at baseline, 6, 12, 18 and 24 weeks; after 12 weeks the blind is opened and all participants may receive the combination for an additional 12 weeks. The primary endpoint is the proportion achieving an ASAS40 response at 12 weeks, with secondary endpoints including symptom severity, disease activity (ASDAS-CRP), functional scores, quality of life, imaging progression, and safety. Adverse events will be recorded throughout to compare tolerability between the regimens.

Why it matters

Potential benefit: If effective, the combination could yield higher ASAS40 response rates and better symptom control and physical function than etanercept alone.

How similar studies have gone: Combining antibiotics with TNF inhibitors for spondyloarthritis is relatively novel and prior data are limited and inconsistent, so large-scale proof of benefit is lacking.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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;

Exclusion Criteria:

he exclusion criteria are as follows: (1) Subjects with nasopharyngitis, active tuberculosis, inflammatory bowel disease and other infections, other rheumatic and immune diseases, malignant tumors, and concomitant bone and joint diseases; (2) Individuals who are allergic to the components of the experimental drug; (3)Severe abnormalities in liver and kidney function (liver enzymes ≥ 2 times normal; creatinine ≥ 2 times normal); (4)Pregnant, preparing for pregnancy or breastfeeding women; (5)Moderate to severe heart failure (New York Heart Association grades 3-4); (6)Some researchers believe that other situations are not suitable for the use of etanercept or other experimental drugs; (7)Active gastrointestinal ulcer/bleeding; (8) According to the researcher's judgment, it is not suitable to participate in this study; (9)Patients in the acute phase of streptococcal infection: present with clinical manifestations of acute pharyngitis, acute tonsillitis, scarlet fever, and streptococcal pyoderma, and ASO or ADNS\>normal range, and/or CRP\>normal range.

Where it's running

  • Nan Fang Hospital, Southern Medical University
    Guangzhou, Guangdong, China     Recruiting
  • Nan Fang Hospital, Southern Medical University
    Guangzhou, Guangdong, China     Recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui, China     Not yet recruiting
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China     Not yet recruiting
  • Inner Mongolia People's Hospital
    Hohhot, Inner Mongolia, China     Not yet recruiting
  • Ganzhou People's Hospital
    Ganzhou, Jiangxi, China     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Spondyloarthritis (SpA) 6Ankylosing Spondylitis (AS) 13Nanfang Hospital, Southern Medical University 93
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.