Safety and Effectiveness of Benzathine Penicillin Combined with Etanercept for Treating Spondyloarthritis in Adults Aged 18 to 59

What this Trial Is About

Researchers are evaluating the combination treatment of Benzathine penicillin BPG and Etanercept ETN in adults with spondyloarthritis SpA. The study aims to confirm the clinical feasibility of this combination and compare it to Etanercept maintenance therapy alone in reducing disease activity, improving symptoms, enhancing quality of life, and assessing safety and imaging outcomes. This randomized, double-blinded, placebo-controlled trial is conducted across multiple centers to provide reliable data on these treatments. Participants will be randomly assigned to one of two groups one receiving BPG injections 1.2 million units intramuscularly every two weeks plus ETN injections 25 mg twice weekly, and the other receiving placebo injections plus ETN, both for 12 weeks under blinded conditions. After 12 weeks, all participants will receive open-label BPG combined with ETN for an additional 12 weeks. Follow-up visits occur at baseline, 6, 12, 18, and 24 weeks to monitor progress. Throughout the study, participants will undergo assessments including symptom severity, disease activity indexes, quality of life scales, imaging scores, and safety monitoring. The primary outcome is the rate of ASAS40 remission after 12 weeks. Secondary outcomes include various disease activity scores and patient-reported assessments measured at multiple points. Adverse events will be recorded to evaluate safety. The total study duration for each participant is 24 weeks.

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis