Benzathine penicillin plus etanercept for spondyloarthritis

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

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

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 6 sites (Hefei, Anhui and 5 other locations)
• Trial ID: NCT06707194 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hefei, Anhui and 5 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Nan Fang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Nan Fang Hospital, Southern Medical University — Guangzhou, Guangdong, China (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

• Study coordinator: Jun Xiao

Conditions Spondyloarthritis; Ankylosing Spondylitis; spondyloarthritis; benzathine penicillin; Etanercept