NCT06707194 Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis
| NCT ID | NCT06707194 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Spondyloarthritis (SpA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2025-06-14 |
| Primary Completion | 2027-03-01 |
Trial Parameters
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Brief 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 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