A Randomized Open-labeled Study for Comparing Methods of Using Imrecoxib to Treat AS

Launched by SHANGHAI ZHONGSHAN HOSPITAL · May 20, 2020

Keywords

ClinConnect Summary

Ankylosing spondylitis (AS) is a chronic systemic inflammatory arthritis of unknown etiology, occurring in young men aged 16-25 and presenting the genetic predisposition. AS is a common rheumatic disease, with a prevalence of 0.3 \~ 0.5% in general people of China, which means that about 5 million people in our country suffer from this disease. AS mainly invades the central axis, characterized by the inflammation of sacroiliitis and attachment points. The onset of AS is insidious. The early clinical manifestations are mainly inflammatory low back pain, which gradually affects the lumbar spi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 \~ 65 (both ends included), regardless of gender;
• • 2. The condition is in the active period, evaluation criteria: Bath Ankylosing Spondylitis-Disease Activity Index (BASDAI) ≥4 (scale 0-10cm);
• • 3. ESR ≥20mm / h or hsCRP ≥3mg / L;
• • 4. Naive patients who have not received any drugs or physical treatment to treat the AS; or patients who discontinued all therapeutic drugs for more than 3 months.
• • 5. Female subjects with fertility must agree to take effective contraceptive measures in the trial.
• Exclusion Criteria:
• • 1. complicated with other rheumatic diseases, such as inflammatory bowel disease, psoriasis, active uveitis, rheumatoid arthritis, systemic lupus erythematosus, primary Sjogren's syndrome, systemic vasculitis, etc.
• • 2. the anti-infection treatment due to the active periods of acute and chronic infections such as mycobacterium tuberculosis, hepatitis B, hepatitis C, HIV, etc.
• • 3. complicated with the malignant tumor.
• • 4. complicated with the drug allergies (including sulfonamides, NSAIDs, etc.), allergic diseases or allergies.
• • 5. Pregnant or lactating women.
• • 6. Abnormal blood system: hemoglobin \<80g / L, white blood cells \<4.0 × 109 / L, platelet \< 100 × 109 / L.
• • 7. Insufficient liver and kidney function: 1.5 times higher than the upper limit of normal value of ALT and AST; 1.25 times higher than the upper limit of normal value of creatinine and urea nitrogen.
• • 8. Insufficient heart function: New York's heart association (NYHA) level ≥ grade II.
• • 9. The usage of analgesic drugs (such as methadone, morphine, etc.) within 4 weeks before baseline.
• • 10. Patients received the spine or joint surgery within 2 months before of the enrollment.
• • 11. Patients participated the any other clinical trials within 3 months before of the enrollment.
• • 12. Patients received live vaccination within 3 months before the enrollment.
• • 13. Patients refused to sign the informed consent form, or the patient lack the capacity to decide for themselves.
• Elimination criteria:
• • 1. Violation of the diagnostic criteria for AS.
• • 2. Serious violation of the trial, and the investigators believe that it is not feasible to exclude subjects who cannot be evaluated for effectiveness.
• • 3. No follow-up records after the enrollment.
• • Exit criteria
• • 1. The subjects request to stop using the experiment drug in the study.
• • 2. Investigators believe that subjects should be withdrawn due to clinical adverse events.
• • 3. The subject is pregnant.
• • 4. Serious violation of the study protocol, which affects the effectiveness and safety evaluation.
• • 5. The subject cannot or does not comply with the requirements of the research project.
• • 6. Subjects who receive any surgical treatment in the study.
• • 7. The investigators believe that further participation in the study is not consistent with the best interests of the subjects.