Spondyloarthritis
Conditions
Interventions
Experimental group:Blinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
Control group:Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily participate and sign an informed consent form; 2. 18 years old = 4cm, total back pain >= 4cm on the Visual Analog Scale (VAS), or >= 1-hour morning stiffness; 5. Poor response or adverse reactions to >= 2 NSAIDs drugs (such as cyborides, etoposide, etc.) or traditional synthetic DMARDs (such as methotrexate, sulfasalazine, leflunomide, or alamod, etc.); 6. Meet one of the following conditions: (1) Have not received treatment with biological agents to improve the condition and anti rheumatic drugs (bDMARD na ï ve); (2) Discontinue treatment with = 12 weeks), or develop adverse reactions due to intolerance (regardless of treatment duration); (3) For patients who have been previously exposed to two types of bDMARD biologics, it is allowed to have adverse reactions due to a lack of efficacy in one biologics bDMARD and intolerance to the other, but patients cannot have a lack of efficacy in both biologics bDMARD; 7. There is laboratory or histological evidence of combined streptococcal infection, meeting one of the following conditions: (1) ASO or ADNS>normal range; (2) FISH test positive (indicating the presence of streptococcal RNA);
Exclusion criteria
Exclusion criteria: 1. Lack of efficacy and intolerance to etanercept; 2. Allergies to experimental drugs (such as penicillin, etanercept, or vitamin C), such as urticaria; 3. Has a history of significant illnesses, including but not limited to those that the investigator believes may interfere with the research procedure and/or evaluation of cardiovascular, renal, gastrointestinal, and lymphatic diseases; 4. Nasopharyngitis, tuberculosis, inflammatory bowel disease and other infections (hepatitis B, HIV, syphilis, etc.), other rheumatic immune diseases (rheumatoid arthritis, etc.), malignant tumors, active gastrointestinal ulcer/bleeding, and other bone and joint diseases; 5. The medical history, diagnosis, signs or symptoms of any clinically significant mental illness, including but not limited to: mental illness, somatic symptom disorder, bipolar disorder; Depression with hospitalization or suicidal behavior within the past 5 years (expected not to require medication for depression or anxiety during the study period), or any other mental illness which the investigator believes would make the subjects unsuitable to participate in the study; 6. Medical history or evidence of clinically significant multiple or severe drug allergies (including monoclonal antibody allergies) or severe post-treatment hypersensitivity reactions (including but not limited to severe erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome, exfoliative dermatitis); 7. Liver: (1) Screening alanine aminotransferase (ALT) >1.5 XULN; (2) Screening bilirubin >1.5 XULN (if bilirubin fractionation is performed and direct bilirubin 1.5 XULN is acceptable); (3) Current liver disease/history of chronic liver disease or known liver/gallbladder abnormalities (excluding Gilbert syndrome or asymptomatic gallstones); 8. Evidence of renal insufficiency, estimated creatinine clearance at screening 2 biological agents (e.g., monoclonal antibodies, including marketed drugs); (3) Use of traditional Chinese medicine within 28 days prior to randomization; 12. Current enrollment or prior participation in clinical studies with investigational drugs within 30 days or 5 half-lives (whichever longer) after signing informed consent; 13. Subjects are immediate family of investigators or staff assisting the study (secretaries, nurses, technicians); 14. Unlikely to comply with protocol (e.g., uncooperative attitude, inability to return for follow-up, inability to complete daily e-logs) and/or deemed by investigator unlikely to complete the study; 15. Acute streptococcal infection: clinical manifestations including acute pharyngitis, acute tonsillitis, scarlet fever, or streptococcal pyoderma; 16. Recent/planned pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient ASAS40 remission rate after 12 weeks of patient medication;Change From Baseline in Indicators of streptococcal infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of Spondyloarthritis Research Consortium of Canada Score;ASAS40 remission rate;Change From Baseline in Patient Global Assessment;Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score(SPARCCSSS);Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)Score;Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score;C-reactive protein-based Ankylosing Spondylitis Disease Activity Score;Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS) ;Terms and Conditions for Using the 36-Item Short Form Survey(SF-36)(Physical Functioning (PF)Mental Health (MH) );Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score ;Change From Baseline in Maastricht ankylosing spondylitis enthesitis (MASES) score;Change From Baseline in Bath Ankylosing Spondylitis-Global (BAS-G) Score;Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Questionnaire;Change From Baseline in Swollen Joint Count, Tender Joint Count; | — |
Countries
China
Contacts
Public ContactXiao Jun
Nanfang Hospital, Southern Medical University
Outcome results
None listed