A Randomized Open-labeled Study for Comparing Methods of Using Imrecoxib to Treat AS
1 other identifier
interventional
196
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 27, 2020
May 1, 2020
1.7 years
May 20, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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.
- +3 more secondary outcomes
Study Arms (2)
On-demand treatment
EXPERIMENTALThis 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.
Continuous treatment
ACTIVE COMPARATORThis group of 98 ankylosing spondylitis patients is prescribed with continuous Imrecoxib (100mg.bid.po) for 24 weeks. The sulfasalazine (500mg.tid.po) is used.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Zhongshan Hospitallead
- Wu Jieping Medical Foundationcollaborator
Study Sites (1)
Lindi Jiang
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lindi Jiang, PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 26, 2020
Study Start
May 7, 2020
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share