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Efficacy and safety of reduced-dose therapy with benzathine penicillin combined with etanercept in maintaining clinical remission in axial spondyloarthritis: a prospective, randomized, blinded endpoint (PROBE) trial based on the extension of the BPEAS trial

Efficacy and safety of reduced-dose therapy with benzathine penicillin combined with etanercept in maintaining clinical remission in axial spondyloarthritis: a prospective, randomized, blinded endpoint (PROBE) trial based on the extension of the BPEAS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125310
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial spondyloarthritis

Interventions

Experimental group:Benzathine penicillin/ETN dose reduction combined treatment regimen
Control group:ETN decremental maintenance therapy alone

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with axial spondyloarthritis who have completed the BPEAS trial and are currently in clinical remission (ASDAS-CPR normal range; 4.Patients with concurrent streptococcal infection (with laboratory or histological evidence of concurrent streptococcal infection) and positive FISH test results (indicating the presence of streptococcal RNA);

Exclusion criteria

Exclusion criteria: 1.Subjects with nasopharyngitis, active tuberculosis, inflammatory bowel disease and other infections, other rheumatic and immune diseases, malignant tumors, and comorbidities involving other bone and joint diseases; 2.Severe abnormalities in liver and kidney function (liver enzymes >= 2 times the normal value; creatinine >= 2 times the normal value); 3.Women who are pregnant, planning to become pregnant, or breastfeeding; 4.Moderate to severe heart failure (New York Heart Association class 3-4); 5.Active gastrointestinal ulcer/bleeding;

Design outcomes

Primary

MeasureTime frame
The ASAS40 remission rate of the patient after 48 weeks of medication;

Secondary

MeasureTime frame
Ankylosing Spondylitis Quality of Life Scale (SQOL-AS);The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES);Improvement rate of the Spondyloarthritis Research Consortium of Canada (SPARCC) score;Bath Ankylosing Spondylitis Global Score (BAS-G);Overall patient evaluation;Streptococcus infection indicator;Improvement rate of the Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score (SPARCC-SSS);Anteroposterior pelvic radiograph;Short Form 36 Health Survey (Physical Functioning, Mental Health) (SF-36);Swollen Joint Count, Tender Joint Count;ASAS40 response rate;Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score;Work efficiency and activity impairment questionnaire for specific health issues;Bath Ankylosing Spondylitis measurement index (basmi) score;Bath Ankylosing Spondylitis Functional Index (BASFI) score;Asas20 response rate;

Countries

China

Contacts

Public ContactJun Xiao

Southern Medical University Southern Hospital

orthopaedxj@163.com+86 186 6500 0156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026