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NCT06707194RecruitingPhase 4

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study

Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
340 (estimated)
First submitted
24 Nov 2024
Start date
14 Jun 2025
Primary completion date
1 Mar 2027
Lead sponsor
Nanfang Hospital, Southern Medical University
NCT number
NCT06707194

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 340
  • From 14 Jun 2025 to the primary completion date, 1 Mar 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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 times normal; creatinine ≥ 2 times normal); (4)Pregnant, preparing for pregnancy or breastfeeding women; (5)Moderate to severe heart failure (New York Heart Association grades 3-4); (6)Some researchers believe that other situations are not suitable for the use of etanercept or other experimental drugs; (7)Active gastrointestinal ulcer/bleeding; (8) According to the researcher's judgment, it is not suitable to participate in this study; (9)Patients in the acute phase of streptococcal infection: present with clinical manifestations of acute pharyngitis, acute tonsillitis, scarlet fever, and streptococcal pyoderma, and ASO or ADNS\>normal range, and/or CRP\>normal range.

Who the study is looking for

  • 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;

Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaNot yet recruiting
Ganzhou People's Hospital
Coordinator of this site? Confirm its status
GanzhouChinaNot yet recruiting
Nan Fang Hospital, Southern Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Anhui Provincial Hospital
Coordinator of this site? Confirm its status
HefeiChinaNot yet recruiting
Inner Mongolia People's Hospital
Coordinator of this site? Confirm its status
HohhotChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.