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Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

ConditionsSpondyloarthritis (SpA)Ankylosing Spondylitis (AS)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-59
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Etanercept

    Biological/Vaccine

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

  • 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

  • Placebo

    Other intervention

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

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: BPG with ETNExperimental treatment 2 interventions
Group B: Placebo with ETNPlacebo comparator 3 interventions

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

1

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

The patients' sacroiliac joint MRIs were scored with reference to the Spondyloarthritis Research Consortium of Canada Score criteria, and the patients' pre-treatment scores were compared to calculate the rate of improvement

Time frame
Baseline and Week 12、24
2

ASAS20 remission rate

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). ASAS20 response is defined as an improvement of ≥20% and ≥1 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.

Time frame
Week 6、12、18、24
3

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

The patients' sacroiliac joint MRIs were scored with reference to the Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score criteria, and the patients' pre-treatment scores were compared to calculate the rate of improvement

Time frame
Baseline and Week 12、24
4

Change From Baseline in Patient Global Assessment

Follow-up questionnaires were administered to the patients, including 1. average activity score of the spondylitis condition in the past week (0-10: never active to very active); 2. activity score of spondylitis in nocturnal pain (0-10: never active to very active)

Time frame
Baseline and Week 6、12、18、24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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