This study is a study to evaluate the safety and efficacy of administering niacin sustained-release capsules to rheumatoid arthritis with hyperlipidemia patients. Sixty patients were randomly assigned to niacin or placebo for 12 weeks, followed by niacin for 12 weeks. Changes in disease activity score, immune cell subtypes, markers of intestinal damage, intestinal flora, and other laboratory indicators will be monitored.
In this study, a randomized double-blind placebo study was conducted to treat patients with rheumatoid arthritis (RA) complicated with dyslipidemia with niacin sustained-release capsules. This study intends to include 60 patients, who are randomly divided into the control group and niacin group in a 1:1 ratio. With the basic treatment of RA unchanged, the administration plan of the two groups is as follows: divided into two stages, the first stage: the niacin group is given a niacin sustained-release capsule orally for 3 months, and the control group is given a placebo orally for 3 months. The second stage: Both groups were given niacin sustained-release capsules for 3 months.The primary endpoint was the change of immune cell subsets, which clarified the immunomodulatory effect of niacin. The secondary end point was to observe the changes in blood lipid, improvement of joint symptoms, effect on intestinal barrier, the effect on intestinal flora, and safety of taking niacin sustained-release capsules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The first stage: the niacin group was given niacin sustained-release capsules for 3 months, and the control group was given placebo for 3 months. The second stage: Both groups were given niacin sustained-release capsules for 3 months. Dosage of niacin sustained-release capsules and placebo: 500mg once a day for week 1-4; The dose is 1000mg once a day for 5 to 12 weeks
The group was given oral placebo for 3 months in the first stage and niacin sustained-release capsules for 3 months in the second stage. Dosage of niacin sustained-release capsules and placebo: 500mg once a day for week 1-4; The dose is 1000mg once a day for 5 to 12 weeks.
Changes in the percentages and counts of T cell subsets assessed by flow cytometry.
Evaluating changes in the percentage of regular T cell subsets in peripheral blood before and after treatment by flow cytometry.
Time frame: Baseline, 4 weeks and 12 weeks
Changes in disease Activity Score in 28 joints (DAS28) assessed by physician.
Evaluating changes in DAS28 (Disease Activity Score 28) before and after treatment. DAS28 was calculated by the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (mm/h) or c-reactive protein (CRP) (mg/L), and patient's global assessment (PGA) of disease activity. Compared with the baseline, a lower DAS28 would mean an improvement in disease activity. Conversely, an increase in DAS28 indicates a deterioration in disease activity. The specific classification of activity levels is as follows:low activity (DAS28 \< 2.6), moderate activity (2.6 ≤ DAS28 ≤ 3.2), high activity (3.2 \< DAS28 ≤ 5.1), and extremely high activity (DAS28 \> 5.1)
Time frame: Baseline,12 weeks
Changes in the simplified disease activity index (SDAI) assessed by physician
Evaluating changes in SDAI before and after treatment. The SDAI is a composite score based on the tender joints of 28 joints (TJC28), tender joints of 28 joints (SJC28), patients' and physicians' global assessments of disease activity, and c-reactive protein (CRP). Compared with the baseline, a lower SDAI would mean an improvement in disease activity. Conversely, an increase in SDAI indicates a deterioration in disease activity. The specific classification of activity levels is as follows:clinical remission (SDAI≤ 3.3), low activity (3.3 \< SDAI≤11), moderate activity (11 \< SDAI≤ 26), and high activity (SDAI\> 26)
Time frame: Baseline and 12 weeks
Changes in the clinical disease activity index (CDAI) assessed by physician
Evaluating changes in CDAI before and after treatment. The Clinical Disease Activity Index (CDAI) is a composite score based on the TJC28, SJC28, and patients'and physicians'assessments. Compared with the baseline, a lower CDAI would mean an improvement in disease activity. Conversely, an increase in CDAI indicates a deterioration in disease activity. The specific classification of activity levels is as follows: clinical remission (CDAI≤ 2.8), low activity (2.8 \< CDAI≤10), moderate activity (10 \< CDAI≤ 22), and high activity (CDAI\> 22)
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Time frame: Baseline and 12 weeks
ACR 20/50/70 response rate assessed by physician
Proportion of patients with ACR20/50/70. The assessment was based on a 20%/50%/70% or greater improvement in the number of joint tenderness or joint swelling compared to baseline and a 20%/50%/70% or greater improvement in three of the remaining five core measures, which included: Patient's overall assessment of disease activity, physician's overall assessment of disease activity, patient's assessment of arthritis pain, HAQ-DI, and acute phase reactant levels (ESR vs. CRP).
Time frame: Baseline and 12 weeks