SAID(Non-Steroidal Anti-Inflammatory Drugs) Discontinuation study on Disease stable Rheumatoid arthritis patients
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000870
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Among 109 enrolled patients, 105 completed the 16-week follow-up. Eighty-nine (84.8%) patients remained without restarting NSAIDs. In these patients, there was a slight increase in their pain levels compared with baseline (median 14.0 versus 19.0 using the pain-visual analog scale, p = 0.010). However, changes in DAS28-ESR (p = 0.638) and routine assessment of patient index data 3 (RAPID-3) (p = 0.128) were insignificant. Moreover, 66 (62.9%) patients showed sustained effectiveness on PRO without restarting NSAIDs. In the multivariate regression models, joint swelling was the detrimental factor in NSAID withdrawal (odds ratio [OR] 0.149, 95% confidence interval [CI] 0.033–0.680, p = 0.014) and sustained effectiveness (OR 0.284, 95% CI 0.091–0.883, p = 0.030). Joint pain in RA patients in remission or with LDA can be well managed without NSAIDs, especially in those without swollen joints at the time of cessation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1) Patients with RA who fulfill the 1987 ACR classification criteria for RA and diagnosed at least 6 months before enrollment.
2) DAS28-ESR < 3.2 in two consecutive examinations apart for at least 1 month
3) Regularly taking any type of NSAID for more than 4 weeks (irrespective of dose)
4)Patient who take regularly takes less than 7.5mg of oral steroids over a month.
5)Patients who understand about the study, and provided informed consent
1) Patients enrolled in other phase 1,2,3 clinical trials.
2) Patients who had any type of adverse effects of acetaminophen (Patients who has elevated AST/ALT levels more than 2 times of upper normal range of reference value)
3) Patients with concurrent fibromyalgia or severe osteoarthritis with Kellgren grade III/IV
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who do not take any type of NSAID(Non-Steroidal Anti-Inflammatory Drugs) during the 16 weeks of study period
- Secondary Outcome Measures
Name Time Method Change of DAS-28 score during study period ;Change of RAPID3(Routine Assesment of Patient Index Data) score during study period;Clinical characteristics of patients who re-start any type of NSAID(Non-Steroidal Anti-Inflammatory Drugs) during study period;Clinical characteristics of patients who do not take any type of NSAID(Non-Steroidal Anti-Inflammatory Drugs) during study period