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Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

StatusRecruiting
PhasePhase 4
Started2025-06-14
View on ClinicalTrials.gov ↗

Amendment history

2025-06-23
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-09-30→2027-03-01
Completion date2026-09-30→2027-07-31
Start dateestimated 2025-03-01→confirmed 2025-06-14
Enrollment target208→340
Study sites5→6
Secondary endpoints15 entries, revised
ASAS40ASAS20 remission rate
Primary endpoints1 entry, revised
Patient ASAS20ASAS40 remission rate after 12 weeks of patient medication
Study description+12 characters
[...] s before randomization), a treatment period (24 weeks), and 45 follow-up visits (Weeks 0, 46, 12,18 and 24). After a 2-week preparation period, 208340 patients with SpA will be randomly and equally assigned to [...] eeks of treatment. Follow-up will be conducted at baseline, 46 weeks,12 weeks,18 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS20ASAS40 in patients after 12 weeks of medication. The secondary out [...]
2024-11-24
Original filing
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.
Trial Details
NCT Number NCT06707194
Lead Sponsor Nanfang Hospital, Southern Medical University
Conditions Spondyloarthritis (SpA), Ankylosing Spondylitis (AS)
Enrollment 340 participants
Start Date 2025-06-14
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-26