Ankylosing Spondylitis Clinical Trial
Official title:
A Randomized Open-labeled Study for Comparison of Patient-reported Outcomes Between Two Therapeutic Schedules of Imrecoxib in Ankylosing Spondylitis
NCT number | NCT04400786 |
Other study ID # | AROS-MIAS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2020 |
Est. completion date | June 30, 2022 |
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 determine which is better in treating AS in the methods between on-demand treatment and continuous treatment. To solve this question, we designed this study.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Lindi Jiang | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | Wu Jieping Medical Foundation |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percent of subjects who achieved moderate improvement in SRM at the 24th week; | The indicator to evaluate the improvement of ASAS HI is the standardized response mean (SRM, SRM = mean / standard deviation the interval of ASAS HI before and after treatment), SRM <0.4 indicates mild improvement, SRM 0.4-0.79 indicates moderate improvement, SRM=0.8 indicates severe improvement.The percent of patients who achieved moderate improvement in SRM at the 24th week is observed. | 24 weeks | |
Secondary | The percent of subjects who achieved moderate improvement in SRM at the 12th week. | The indicator to evaluate the improvement of ASAS HI is the standardized response mean (SRM, SRM = mean / standard deviation the interval of ASAS HI before and after treatment), SRM <0.4 indicates mild improvement, SRM 0.4-0.79 indicates moderate improvement, SRM=0.8 indicates severe improvement. The percent of patients who achieved moderate improvement in SRM at the 12th week. | 12 weeks. | |
Secondary | The percent of subjects who achieved severe improvement in SRM at the 12th week. | The indicator to evaluate the improvement of ASAS HI is the standardized response mean (SRM, SRM = mean / standard deviation the interval of ASAS HI before and after treatment), SRM <0.4 indicates mild improvement, SRM 0.4-0.79 indicates moderate improvement, SRM=0.8 indicates severe improvement. The percent of patients who achieved severe improvement in SRM at the 12th week is evaluated. | 12 weeks. | |
Secondary | The percent of subjects who achieved severe improvement in SRM at the 24th week. | The indicator to evaluate the improvement of ASAS HI is the standardized response mean (SRM, SRM = mean / standard deviation the interval of ASAS HI before and after treatment), SRM <0.4 indicates mild improvement, SRM 0.4-0.79 indicates moderate improvement, SRM=0.8 indicates severe improvement. The percent of patients who achieved severe improvement in SRM at the 24th week is evaluated. | 24 weeks. | |
Secondary | The change of self-evaluation compared with the baseline | The slef-evaluation is performed with self-evaluation visual simulation method (0~40, higher score indicate more severe condition). The comparison was made between the baseline and the different time point in the follow-up. | 2, 4, 8, 12, 24 weeks. | |
Secondary | The change of BASDI compared with the baseline. | The disease activity was evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI, 0~70, higher score indicates more severe condition). The comparison was made between the baseline and the different time point in the follow-up. | 2, 4, 8, 12, 24 weeks. | |
Secondary | The relation between disease activity assessment and patient self-assessment | The correlation analysis between disease activity assessment (BASDI) and patient self-evaluation (self-evaluation visual simulation method). | 12, 24 weeks. | |
Secondary | Safety assessment including adverse effects such as gastrointestinal tract symptoms of two prescription strategy | The safety assessment indicates the adverse effects or severe adverse effects in the follow-up including disability, prolonged hospitalization, death and so on. | 2, 4, 8, 12, 24 weeks. | |
Secondary | The cost-effectiveness of two prescription strategy | The average cost-effectiveness ratio analysis of two prescription strategy was compared. | 24weeks. |
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