Actively Recruiting
Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis A Multicenter Randomized Controlled Clinical Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-06-26
340
Participants Needed
6
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree and sign informed consent.
- Aged between 18 and 59 years.
- Diagnosed with spondyloarthritis based on 2009 ASAS axial or 2011 ASAS peripheral classification criteria.
- Currently in a relatively active phase of the disease (ASDAS-CRP > 1.2).
You will not qualify if you...
- Having infections such as nasopharyngitis, active tuberculosis, inflammatory bowel disease, or other serious infections.
- Diagnosed with other rheumatic or immune diseases, malignant tumors, or other bone and joint diseases.
- Allergic to any components of the study drugs.
- Severe liver or kidney dysfunction (liver enzymes or creatinine ≥ 2 times normal).
- Pregnant, planning pregnancy, or breastfeeding.
- Moderate to severe heart failure (NYHA grades 3-4).
- Active gastrointestinal ulcer or bleeding.
- Acute streptococcal infection with clinical symptoms and abnormal ASO, ADNS, or CRP.
- Any condition deemed unsuitable for the study by the researchers based on judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive injections of Benzathine Penicillin or placebo every two weeks combined with Etanercept twice a week for 12 weeks, followed by an open-label period where all participants receive Benzathine Penicillin combined with Etanercept for another 12 weeks.
5 visits at Weeks 0, 6, 12, 18, and 24
Trial Site Locations
Total: 6 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
3
Nan Fang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
4
Nan Fang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China, 010010
Not Yet Recruiting
6
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
Research Team
J
Jun Xiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here