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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacin | Experimental | The first and second stage: niacin sustained-release capsules orally for 3 months |
|
| Placebo | Placebo Comparator | The first stage: placebo for 3 months, the second stage: niacin sustained release capsules for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin sustained release capsules | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of triglyceride assessed by peripheral blood physiological parameter | Evaluating the changes in triglyceride after treatment in peripheral blood. | Baseline, 4 weeks and 12 weeks |
| Changes of cholesterol assessed by peripheral blood physiological parameter |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing He | Contact | 010-88326666 | hejing1105@126.com | |
| Naidi Wang | Contact | 18811618179 | pkuwnd@163.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Placebo | Drug | 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. |
|
| 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) | 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) | 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). | Baseline and 12 weeks |
Evaluating changes in cholesterol after treatment in peripheral blood. |
| Baseline, 4 weeks and 12 weeks |
| Changes in c-reactive protein (CRP) assessed by peripheral blood physiological parameter. | Evaluating changes in concentration of CRP (mg/L) before and after treatment in peripheral blood. | Baseline, 4 weeks and 12 weeks |
| Changes in erythrocyte sedimentation rate (ESR) assessed by peripheral blood physiological parameter. | Evaluating changes in concentration of ESR (mm/h) before and after treatment in peripheral blood. | Baseline, 4 weeks and 12 weeks |
| Changes in serum soluble cluster of differentiation 14 (sCD14) assessed by ELISA. | Evaluating changes in sCD14 concentration in serum before and after treatment by ELISA. | Baseline, 4 weeks and 12 weeks |
| Changes in serum lipopolysaccharide-binding protein (LBP) assessed by ELISA. | Evaluating changes in LBP concentration in serum before and after treatment by ELISA. | Baseline, 4 weeks and 12 weeks |
| Changes in serum intestinal fatty acid-binding protein (I-FABP) assessed by ELISA.. | Evaluating changes in I-FABP concentration in serum before and after treatment by ELISA. | Baseline, 4 weeks and 12 weeks |
| Numbers of participants with treatment-related adverse events assessed by questionnaire. | Adverse effects include fever, rash, abnormal liver and kidney function, new-onset infection, and any abnormal measures associated with experimental drugs were recorded by questionnaire. | 12 weeks |
| Changes in intestinal flora assessed by fecal metagenomic sequencing. | Evaluating the changes of intestinal flora before and after treatment by fecal metagenomic sequencing. | Baseline and 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |