Status:
UNKNOWN
A Randomized Open-labeled Study for Comparing Methods of Using Imrecoxib to Treat AS
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Wu Jieping Medical Foundation
Conditions:
Ankylosing Spondylitis
Therapeutic Agent Toxicity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The selective cox-2 inhibitor has been widely used in the treatment of Ankylosing spondylitis (AS). The Imrecoxib is a new cox-2 inhibitor. But the treatment strategy has not been decided yet. To dete...
Detailed Description
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 dise...
Eligibility Criteria
Inclusion
- Age 18 \~ 65 (both ends included), regardless of gender;
- The condition is in the active period, evaluation criteria: Bath Ankylosing Spondylitis-Disease Activity Index (BASDAI) ≥4 (scale 0-10cm);
- ESR ≥20mm / h or hsCRP ≥3mg / L;
- 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.
- Female subjects with fertility must agree to take effective contraceptive measures in the trial.
Exclusion
- 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.
- the anti-infection treatment due to the active periods of acute and chronic infections such as mycobacterium tuberculosis, hepatitis B, hepatitis C, HIV, etc.
- complicated with the malignant tumor.
- complicated with the drug allergies (including sulfonamides, NSAIDs, etc.), allergic diseases or allergies.
- Pregnant or lactating women.
- Abnormal blood system: hemoglobin \<80g / L, white blood cells \<4.0 × 109 / L, platelet \< 100 × 109 / L.
- 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.
- Insufficient heart function: New York's heart association (NYHA) level ≥ grade II.
- The usage of analgesic drugs (such as methadone, morphine, etc.) within 4 weeks before baseline.
- Patients received the spine or joint surgery within 2 months before of the enrollment.
- Patients participated the any other clinical trials within 3 months before of the enrollment.
- Patients received live vaccination within 3 months before the enrollment.
- Patients refused to sign the informed consent form, or the patient lack the capacity to decide for themselves.
- Elimination criteria:
- Violation of the diagnostic criteria for AS.
- Serious violation of the trial, and the investigators believe that it is not feasible to exclude subjects who cannot be evaluated for effectiveness.
- No follow-up records after the enrollment.
- Exit criteria
- The subjects request to stop using the experiment drug in the study.
- Investigators believe that subjects should be withdrawn due to clinical adverse events.
- The subject is pregnant.
- Serious violation of the study protocol, which affects the effectiveness and safety evaluation.
- The subject cannot or does not comply with the requirements of the research project.
- Subjects who receive any surgical treatment in the study.
- The investigators believe that further participation in the study is not consistent with the best interests of the subjects.
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04400786
Start Date
May 7 2020
End Date
June 30 2022
Last Update
May 27 2020
Active Locations (1)
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1
Lindi Jiang
Shanghai, China, 200032