ankylosing spondylitis
Conditions
Interventions
Experimental group:Usual treatment and focus addresses short-term treatment patterns
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age 20 to 50 years old (including boundary value, subject to the day of signing the informed consent form), gender is not limited. 2. All have undergone comprehensive rheumatological examination and were diagnosed with active ankylosing spondylitis, which meets the improved New York classification standards for ankylosing spondylitis after the revision in 1984. 3. Those who show clear awareness, can accurately express their wishes, agree to answer questionnaires, can be contacted by phone, can follow the plan and have the ability to carry out relevant procedures. 4. After the implementation of informed consent, voluntarily sign the informed consent form. 5. If the subject is taking NSAIDs or other analgesics (such as acetaminophen or weak opioids), a stable dose is required for = 2 weeks before randomization; If participants did not take the above drugs orally at a stable dose, they were discontinued for at least = 2 weeks before randomization. 6. Patients who are taking methotrezine (MTX) (7.5-25mg/week) or sulfasalazine (=3g/day) are allowed to continue using the drug, but continued treatment is required for = 3 months before randomization, and the stable dose lasts for = 4 weeks; If participants did not take the above drugs orally at a stable dose, they were discontinued for at least 4 weeks before randomization. 7. If the subject is using a biological agent and a stable dose is required for = 4 weeks before randomization; If participants did not use the above drugs at a stable dose, they were discontinued for at least 4 weeks before randomization.
Exclusion criteria
Exclusion criteria: 1. General: 1) Women who are pregnant or lactating (pregnancy is defined as a state after conception until termination of pregnancy) and test positive for human chorionic gonadotropin (hCG) test; 2) Have a history of alcohol or illegal drug abuse within one year prior to screening; 3) The investigator judges that there are circumstances that affect the safety and efficacy evaluation of the research drug; 4) Those who refuse to participate in the trial after being explained by the investigator 2. Within 4 weeks prior to randomization, the following conditions occur in laboratory tests and/or 12-Lead ECG: 1) hemoglobin (male) 500ms). 3. Presence of any of the following medical history or comorbidities 1) complete rigidity of the spine (fusion); 2) Have undergone spine surgery or joint surgery within 6 months before screening; 3) Have a history of inflammatory bowel disease or other persistent active autoimmune diseases; 4) tuberculosis (TB) or occult tuberculosis infection; 5) active systemic infection (e.g., hepatitis) within 2 weeks prior to randomization or severe feeling requiring hospitalization and/or intravenous antibiotics within 8 weeks prior to randomization; 7) Have a history of malignant swelling of the lymphatic system such as lymphoma or Muba proliferative disease: or indicate that there may be lymphoproliferative disease or splenomegaly on the symptoms and rest of the box; 8) Grade 2 hypertension or above (systolic blood pressure (SBP) = 160mmHg and/or diastolic blood pressure (DBP) =100mmHg] at rest; 9) Have or have had malignant tumors within 5 years before screening (except for cutaneous squamous cell carcinoma, basal cell carcinoma or carcinoma in situ of the cervix that has been completely resected and has no evidence of recurrence); 10) Have moderate to severe congestive heart failure (New York Heart Association Class II or IV); 11) Have a history of organ transplantation (except for those who have been screened for corneal transplantation = 3 months before screening); 12) Serious, progressive, uncontrolled cardiovascular and cerebrovascular, liver, kidney, lung, gastrointestinal, hematopoietic, endocrine, nervous and psychiatric systems (such as depression, suicidal tendencies and psychological disorders) and other diseases, as well as other researchers believe that patients are not suitable to join this trial. 4. Use of other drugs or participation in clinical studies (defined as signing informed consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BASDAI;BASFI;VAS;HAQ-S;HADS;ASQoL; | — |
Countries
China
Contacts
Public ContactWang Saisai
Zhejiang Provincial People's Hospital
Outcome results
None listed