Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

Official title

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

Overview

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.

Detailed description

This trial is a randomised, double-blinded, placebo-controlled, polycentric study. The study consisted of a screening period (up to 2 weeks before randomization), a treatment period (24 weeks), and 5 follow-up visits (Weeks 0, 6, 12,18 and 24).

After a 2-week preparation period, 340 patients with SpA will be randomly and equally assigned to either experimental group consisting of BPG (injection form, 1.2 million units of intramuscular injection, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week) or the control group consisting of placebos (injection form, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week),with treatment lasting for 12 weeks. After 12 weeks of treatment, the label will be opened, and all patients will choose to use BPG combined with ETN maintenance therapy for another 12 weeks of treatment. Follow-up will be conducted at baseline, 6 weeks,12 weeks,18 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS40 in patients after 12 weeks of medication. The secondary outcomes are the severity of symptoms, disease activity, quality of life, and imaging progression scale scores of patients at each follow-up point. We will synchronize the recording of adverse events to compare the safety of the two treatment regimens

Interventions

• Biological Etanercept
  Prefilled syringe, 25mg of hypodermic injection, twice a week
• Drug Benzathine Penicillin
  Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, 1.2 million units of intramuscular injection, once every two weeks
• Other Placebo
  Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, intramuscular injection, once every two weeks

Primary outcome measures

• Patient ASAS40 remission rate after 12 weeks of patient medication [Time frame: Week 12]

Secondary outcome measures (12)

• Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC） [Time frame: Baseline and Week 12、24]
• ASAS20 remission rate [Time frame: Week 6、12、18、24]
• Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS） [Time frame: Baseline and Week 12、24]
• Change From Baseline in Patient Global Assessment [Time frame: Baseline and Week 6、12、18、24]
• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score [Time frame: Baseline and Week 6、12、18、24]
• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score [Time frame: Baseline and Week 6、12、18、24]
• C-reactive protein-based Ankylosing Spondylitis Disease Activity Score（ASDASCRP） [Time frame: Baseline and Week 6、12、18、24]
• Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS) [Time frame: Baseline and Week 6、12、18、24]
• Terms and Conditions for Using the 36-Item Short Form Survey（SF-36）（Physical Functioning (PF)、Mental Health (MH) ） [Time frame: Baseline and Week 6、12、18、24]
• Bath Ankylosing Spondylitis Metrology Index (BASMI) Score [Time frame: Baseline and Week 12、24]
• Change From Baseline in Maastricht ankylosing spondylitis enthesitis （MASES） score [Time frame: Baseline and Week 12、24]
• Change From Baseline in Bath Ankylosing Spondylitis-Global （BAS-G） Score [Time frame: Baseline and Week 6、12、18、24]

Eligibility criteria

Inclusion criteria

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;

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 6 centers

• Anhui Provincial Hospital — Hefei
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing
• Nan Fang Hospital, Southern Medical University — Guangzhou
• Nan Fang Hospital, Southern Medical University — Guangzhou
• Inner Mongolia People's Hospital — Hohhot
• Ganzhou People's Hospital — Ganzhou

Identifiers

NCT: NCT06707194 · NFEC-2025-283 · NFSC-2024-060

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗