Clinical trial NCT06707194: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spondyloarthritis (SpA)
Ankylosing Spondylitis (AS)
Keywords: spondyloarthritis
benzathine penicillin
Etanercept
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 4 follow-up visits (Weeks 0, 4, 12 and 24).

After a 2-week preparation period, 208 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, 4 weeks,12 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS20 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

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.

Primary outcomes:
measure: Patient ASAS20 remission rate after 12 weeks of patient medication
timeFrame: Week 12
Secondary outcomes:
measure: Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC）
timeFrame: Baseline and Week 4、12、24
measure: ASAS40 remission rate
timeFrame: Baseline and Week 4、12、24
measure: Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS）
timeFrame: Baseline and Week 4、12、24
measure: Change From Baseline in Patient Global Assessment
timeFrame: Baseline and Week 4、12、24
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score
timeFrame: Baseline and Week 4、12、24
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: Baseline and Week 4、12、24
measure: C-reactive protein-based Ankylosing Spondylitis Disease Activity Score（ASDASCRP）
timeFrame: Baseline and Week 4、12、24
measure: Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS)
timeFrame: Baseline and Week 4、12、24
measure: Terms and Conditions for Using the 36-Item Short Form Survey（SF-36）（Physical Functioning (PF)、Mental Health (MH) ）
timeFrame: Weeks 0、4、12、24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Score
timeFrame: Weeks 0、4、12、24
measure: Change From Baseline in Maastricht ankylosing spondylitis enthesitis （MASES） score
timeFrame: Weeks 0、4、12、24
measure: Change From Baseline in Bath Ankylosing Spondylitis-Global （BAS-G） Score
timeFrame: Weeks 0、4、12、24
measure: Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Questionnaire
timeFrame: Weeks 0、4、12、24
measure: Change From Baseline in Swollen Joint Count, Tender Joint Count
timeFrame: Weeks 0、4、12、24
measure: Change From Baseline in Indicators of streptococcal infection
timeFrame: Weeks 0、4、12、24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Nan Fang Hospital, Southern Medical University
state: Guangdong
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
Study officials:
References: