Therapy of Niacin for Rheumatoid Arthritis

NCT07004725 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Niacin RA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis (RA); niacin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes in disease Activity Score in 28 joints (DAS28) assessed by physician.

  Baseline,12 weeks

• Changes in the simplified disease activity index (SDAI) assessed by physician

  Baseline and 12 weeks

• Changes in the clinical disease activity index (CDAI) assessed by physician

  Baseline and 12 weeks

• ACR 20/50/70 response rate assessed by physician

  Baseline and 12 weeks

Other Outcomes (9)

• Changes of triglyceride assessed by peripheral blood physiological parameter

  Baseline, 4 weeks and 12 weeks

• Changes of cholesterol assessed by peripheral blood physiological parameter

  Baseline, 4 weeks and 12 weeks

• Changes in c-reactive protein (CRP) assessed by peripheral blood physiological parameter.

  Baseline, 4 weeks and 12 weeks

Study Arms (2)

Niacin

EXPERIMENTAL

The first and second stage: niacin sustained-release capsules orally for 3 months

Drug: niacin sustained release capsules

Placebo

PLACEBO COMPARATOR

The first stage: placebo for 3 months, the second stage: niacin sustained release capsules for 3 months

Drug: Placebo

Interventions

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

Niacin

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age at the time of screening, weight≥35 kg.
• Diagnosed with rheumatoid arthritis satisfying the 1987 American College of Rheumatology classification criteria or ACR/EULAR 2010 classification criteria.
• Stable treatment, including DMARDs (disease-modifying anti-rheumatic drugs) and glucocorticoids, was stable in dose for at least 4 weeks, and no biological agents were used during the first 12 weeks of enrollment.
• Dyslipidemia (5.2≤TC≤7.2mmol/L, 3.4≤LDL-c≤4.9mmol/L or 1.7≤TG≤5.1 mmol/L)
• Have given written informed consent.

You may not qualify if:

• a. Patients with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, ankylosing spondylitis, etc.).
• b. Patients with uncontrolled hyperuricemia and gout.
• c. Patients who take lipid-lowering drugs such as statins or fibrates orally, cardiovascular medications (such as aspirin, nitrates, calcium channel blockers, epinephrine blockers).
• d. Patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or multiple erythema.
• e. Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia, excepting those secondary to active rheumatoid arthritis.
• f. Persistent or severe infection within 3 months prior to enrollment.
• g. Uncontrolled high blood pressure, diabetes, atherosclerotic cardiovascular disease, inflammatory bowel disease, peptic ulcer and other digestive diseases, end-stage diseases, or diseases that investigators believe would put patients at risk for study participation.
• h. Clinically relevant cardiovascular, liver, neurological, endocrine, or other major systemic disease that makes the implementation of the protocol or the interpretation of the findings difficult.
• i. Severe liver and kidney function impairment (severe hypoproteinemia with serum albumin \<30g/L, elevated aminotransferase more than 2 times the upper limit of normal, moderate or severe renal function impairment, such as creatinine \>133 μ/L, etc.).
• j. Patients with a recent and clinically severe history of drug or alcohol abuse.
• k. Pregnant.
• l. Breastfeeding.
• m. Subjects who wish to become fathers during the study or within 24 months (or 3 months washout period) after the study;
• n. Patients with congenital or acquired severe immunodeficiency, a history of cancer or lymphoproliferative disease, or patients who have received total lymphoid radiation.
• o. Known HIV-positive status.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jing He

CONTACT

010-88326666; hejing1105@126.com

Naidi Wang

CONTACT

18811618179; pkuwnd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: June 4, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 4, 2025

Record last verified: 2024-12