Juvenile-onset AS (JoAS), Adult-onset AS (AoAS)
Conditions
Interventions
JoAS:YiSaiPu 25mg twice weekly subcutaneous injections
AoAS:YiSaiPu 25mg twice weekly subcutaneous injections
Sponsors
Division of Rheumatology & Immunology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Capable to sign informed consent (informed consent must sign before onset of any research work); 2. Coincidence with 1984 New York separate criteria of revised edition of ankylosing spondylitis, active phase (BASDAI>=4), ankylosing spondylitis; 3. Age of subjects 16-65 years; 4. Child-bearing women agree for using effective contraceptive methods in trail period; 5. In screening time, urine pregnancy test of reproductive age women is negative; 6. Required to narrate tuberculosis screening standard, then consider for enrollment of this research: (1) There is no history of latent TB or active TB before screening; (2) There is no appearing of active TB symptoms or sign on case history and /or physical examination; (3) In recent time, there is no close contact of active TB patients.d)Take chest X-ray within 3 months of first research drug administration (including posterior-anterior position and lateral position). Radiologist interpretation that there is no active TB or olden inactive TB evidence. 7. Permission of oral cortical hormone (prednisolone <10 mg/d or corresponding dose) and NSAIDs (may reach maximum recommended dose), but before baseline period stable dose should be at least above 4 weeks.
Exclusion criteria
Exclusion criteria: 1. 8 weeks before screening, the patient has been doing major operation (including joint operation), or planning of major operation within 6 of enrollment of groups; 2. History of lymphocyte proliferating diseases or other malignant diseases in recent 5 years; 3. Patient suffering from active tuberculosis in recent 3 years; 4. Severe infection in recent 2 months; 5. Received any traditional DMARD within 4 weeks before base line; 6. Received or while receiving virus animatum or bacterial vaccination within 4 weeks of selection; 7. Patients of chronic or recurrent infection diseases, as for example: chronic renal infection, chronic thoracic cavity infection (bronchiectasis), nasal sinusitis, recurrent urinary tract infection, infectivity open wound, infectivity draining or skin wound infection; 8. Already known, there is active or recurrent bacterial, viral, fungal, mycobacterium or other infection history (including no restriction of tuberculosis and atypical mycobacterium diseases, granuloma diseases by chest X-ray, Hepatitis B and C infection, HIV infection, herpes zoster, but not including fungal infection of nail. The patients require hospitalization and intravenous injection of antibiotics within 4 weeks before screening, or require oral antibiotics treatment of infected person within 2 weeks before screening; 9. Congestive heart failure patients; 10. Companion of severe, not yet controlling of cardiovascular diseases, nervous system diseases, pulmonary diseases (including obstructive lung diseases and interstitial lung disease), kidney diseases, liver diseases, endocrine diseases (including not yet controlling of diabetes) and gastrointestinal diseases patients or researcher consider for not suitable for participating of this research; 11.Serum creatinine values are higher than 1.5mg/dl; 12.Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) are 2 times higher than upper limit of normal value (On screening time, if first time determine ALT or AST are 2 times higher than normal upper limit then sample should be collected one more time for determination), or total bilirubin is higher than normal limit (if first determine total bilirubin is higher than normal limit then sample should be collected one more time); 13.Blood platelet count <100*10^9/L, or leucocytes <3*10^9/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20; | — |
Countries
China
Contacts
Public ContactLiu Yi
Outcome results
None listed