Sponsor study identifier
interventional
196
1 country
1
Study Start
May 7, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2020
Actual (reported)May 20, 2020
Actual (reported)May 26, 2020
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
The percent of subjects who achieved moderate improvement in SRM at the 12th week.
12 weeks.
The percent of subjects who achieved severe improvement in SRM at the 12th week.
12 weeks.
The percent of subjects who achieved severe improvement in SRM at the 24th week.
24 weeks.
The change of self-evaluation compared with the baseline
2, 4, 8, 12, 24 weeks.
The change of BASDI compared with the baseline.
2, 4, 8, 12, 24 weeks.
This group of 98 ankylosing spondylitis patients is prescribed with intermittent Imrecoxib (100mg.prn.po) according to the feeling of pain till 24 weeks. The sulfasalazine (500mg.tid.po) is used.
This group of 98 ankylosing spondylitis patients is prescribed with continuous Imrecoxib (100mg.bid.po) for 24 weeks. The sulfasalazine (500mg.tid.po) is used.
According to the feeling of pain, the on-demand treatment group is prescribed with or without Imrecoxib (100mg/tablet, 100mg.prn.po), but the maximal dose does not exceed 100 mg per time, twice (morning and evening) per day. The duration lasted for 24 weeks.
The continuous treatment group is prescribed Imrecoxib (100mg.bid.po) regardless of the pain in the treatment course for 24 weeks.
Lindi Jiang
Shanghai, 200032, China
Lindi Jiang, PhD
Fudan University
First Submitted
May 20, 2020
First Posted
May 26, 2020
Study Start
May 7, 2020
Actual (reported)Primary Completion
December 31, 2021
A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 27, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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