Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Spondyloarthritis (SpA), Ankylosing Spondylitis (AS)

In brief

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.

Key facts

Study ID

NCT06707194

Run by

Nanfang Hospital, Southern Medical University

People needed

340

Starts

2025-06-14

Expected to finish

2027-07-31

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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 is running

• Nan Fang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Nan Fang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Anhui Provincial Hospital — Hefei, Anhui, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Inner Mongolia People's Hospital — Hohhot, Inner Mongolia, China
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China

Full record on ClinicalTrials.gov

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