Axial spinal arthritis/ankylosing spondylitis
Conditions
Interventions
test group:Iguratimod
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male or female aged 18-65, in line with the diagnostic criteria for ankylosing spondylitis in 1984 or axial spondyl arthritis in 2009 1) The disease is in the active phase: ASDAS-CRP >= 2.1; 2) No birth plan during the trial period and within 3 months after the trial ends; 3) Understand the test procedures and content, and voluntarily sign an informed consent form to express consent to participate in the test and accept the medication requirements during the study period.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this study: 1) Allergic to test drugs; 2) At the time of screening, patients who are in the active stage of infectious diseases such as tuberculosis, hepatitis B, and big three positives; 3) Laboratory test results: Hb 1.5 times the upper limit of normal; Renal function (SCr) >= 30; 4) Suffer from other autoimmune diseases whose symptoms and signs are expected to affect the evaluation of test drugs, such as inflammatory enteritis, psoriasis, etc. 5) Active gastrointestinal disease: gastrointestinal bleeding or gastrointestinal diagnosis of active gastrointestinal ulcer or acute gastric mucosal injury occurred in the past three months; 6) Severe cardiovascular, kidney and other important organs, blood, endocrine system diseases, malignant tumors and medical history; 7) Suffer from serious, progressive, uncontrolled diseases of other important organs and systems; 8) Before the registration study and during the study period, have severe cardiovascular disease, kidney, liver and other important organ damage or severe blood system, endocrine system disease (aplastic anemia, hyperthyroidism crisis, etc.), HIV/AIDS or a history of tumors or Receiving chemotherapy, organ or bone marrow transplantation, other connective tissue diseases (systemic lupus erythematosus, Sjogrens syndrome, etc.); 9) People with mental illness; 10) Other conditions deemed unsuitable for participating in the trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 response rate at 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS20 response rate at 12 weeks;ASAS40 response rate at 12 weeks and 24 weeks;ASDAS-CRP compliance rate at 12 weeks and 24 weeks;ASDAS-ESR compliance rate at 12 weeks and 24 weeks;the change in ESR and CRP from baseline at 12 weeks and 24 weeks;Changes in the degree of thoracic expansion at 12 weeks and 24 weeks;Changes in spine mobility at 12 weeks and 24 weeks;AE;SAE; | — |
Countries
China
Contacts
Public ContactHuaxiang Liu
Qilu Hospital of Shandong University
Outcome results
None listed