axial spondyloarthritis
Conditions
Interventions
A:Imrecoxib 200mg/bid po.2weeks
patients who had no symptomatic amelioration or who had symptoms of intolerance were switched to another NSAIDS(Celebrex 200mg bid po) to the end.
B:Celebrex 200mg/bid po. 2weeks
patients who had no symptomatic amelioration or who had symptoms of intolerance were switched to another NSAIDS(Imrecoxib 200mg bid po) to the end.
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. The male or female outpatients aged 18-50 years old can fully cooperation, the growth period women in pregnancy or lactation and ensure no pregnancy during the study; 2. According with the disease classification standards with ASAS recommended in 2009for at least 3 months; 3. Requiring NSAIDs therapy, it is also means undergoing the NSAIDs treatment or other diseases treatment need the use of NSAIDs and are predicted to be treated for more than three months; 4. Not using aspirin and hormone for a long time or not use articular cavity injection drug within six months; 5. Having no cerebrovascular diseases for six months, including unstable angina, acute myocardial infarction, diseases such as acute cerebral ischemia and cerebral infarction, drug control has reached to the stable high blood pressure (Bp) less than 140/90 MMHG); 6. With gastrointestinal symptoms and agree to do gastroscopy before taking the test; 7. Have signed informed consent before entering any research steps.
Exclusion criteria
Exclusion criteria: 1. Taking low-dose aspirin (75mg-100mg) could prevent coronary heart disease. But, according to the relative and absolute risk estimation standards of the male/female patients with coronary heart disease, they are belonging to the high risk group; 2. Patients who have suffered the following cardiovascular situations: (1) During the six months before screening, the patients who suffered myocardial infarction or coronary bypass surgery or traumatic coronary artery recanalization or cerebral apoplexy patients; (2) Unstable angina pectoris (unstable angina pectoris: an increasing frequency of angina pectoris attack, during the 6 months before screening, the new angina, resting angina pectoris and the angina occurred in the slight movement which including decubitus angina (no stimulate state), the angina pectoris occurred at night and variant angina pectoris (Prinzmetal's angina); (3) The ECG showed myocardial ischemia with patients have coronary heart disease; (4) The patients who have symptoms of congestive heart failure after rest or mild exercise; 3. The patients who use anticoagulants (e.g. warfarin, low molecular weight heparin) and antiplatelet drugs; 4. The patients who have active upper gastrointestinal ulcers before the screening within 30 days, or 1 year before the screening have upper gastrointestinal bleeding, or patients who ever have a medical history of gastro duodenal perforation or obstruction; 5. There is no history of stomach surgery in half a year (such as gastric resection or vagotomy), but except for simple ulcers or the Nissen stomach bottom fold for the decompression for the treatment of reflux; 6. The patients who have the medical history of inflammatory bowel disease (such as ulcerative colitis and Crohn's disease) or a history of upper gastrointestinal malignant tumor; 7. There are complications of diverticulitis (such as inflammation, pain or bleeding); 8. The patients who have a medical history of bleeding disorders; 9. The patients with abnormal liver function, renal abnormalities or blood coagulation dysfunction or anemia (hemoglobin is lower than normal lower limit of 20 g/L); 10. The patients who analgesic to antipyretic, wast, drugs and NSAIDs; 11. The patients who have a medical history of treated or untreated malignancy of any organ, with or without evidence of local recurrence or metastasis cannot be selected, except for localized basal cell carcinoma; 12. The patients with obvious disease, including the following situations (but not limited to this): uncontrolled hypertension, I diabetes (controlled well type II, even need to use insulin, can also be selected), thyroid disease with thyroxine (unless the sufferers control their condition for more than 3 months), active liver disease with two years and the serological HIV -positive patients; 13. The patients who think the treatment programs are unreliable; 14. The patients who have a history of drug and alcohol abuse as well as a history of mental illness; 15. The patients who are in the Litigation period in hospital; 16. Using any kind of research-based drug during a month before the screening or still within 10 half-lives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20);Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40);Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI);ESR;CRP;Schober test;Scoliosis;Sacroiliac joint MRI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 15-PGDH;PTGER4;COX-2 gene polymorphism;MMP, NOS, rankle/OPG etc; | — |
Countries
China
Contacts
Public ContactGuanmin Gao
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed