Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

NCT06707194 | Recruiting Phase 4 DMC

• 2 other identifiers: NFEC-2025-283NFSC-2024-060
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Spondyloarthritis (SpA); Ankylosing Spondylitis (AS)

Keywords

spondyloarthritis; benzathine penicillin; Etanercept

Outcome Measures

Primary Outcomes (1)

• Patient ASAS40 remission rate after 12 weeks of patient medication

  Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

  Week 12

Secondary Outcomes (15)

• Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC）

  Baseline and Week 12、24

• ASAS20 remission rate

  Week 6、12、18、24

• Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS）

  Baseline and Week 12、24

• Change From Baseline in Patient Global Assessment

  Baseline and Week 6、12、18、24

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score

  Baseline and Week 6、12、18、24

Study Arms (2)

BPG with ETN

EXPERIMENTAL

Blinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.

Biological: Etanercept; Drug: Benzathine Penicillin

Placebo with ETN

PLACEBO COMPARATOR

Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.

Biological: Etanercept; Drug: Benzathine Penicillin; Other: Placebo

Interventions

Etanercept BIOLOGICAL

Prefilled syringe, 25mg of hypodermic injection, twice a week

BPG with ETN; Placebo with ETN

Benzathine Penicillin DRUG

Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, 1.2 million units of intramuscular injection, once every two weeks

BPG with ETN; Placebo with ETN

Placebo OTHER

Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, intramuscular injection, once every two weeks

Placebo with ETN

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (6)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

NOT YET RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

NOT YET RECRUITING

Nan Fang Hospital, Southern Medical University

Guangzhou, Guangdong, 510080, China

RECRUITING

Nan Fang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, 010010, China

NOT YET RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Spondylarthritis; Spondylitis, Ankylosing

Interventions

Etanercept; Penicillin G Benzathine

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jun Xiao

CONTACT

0086-20-18665000156; orthopaedxj@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: June 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (6)