Rheumatoid Arthritis (RA)Phase 2NCT07004725
Therapy of Niacin for Rheumatoid Arthritis
A Phase 2 study testing niacin sustained release capsules in people with Rheumatoid Arthritis (RA), run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- niacin sustained release capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2025to 15 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- p. Patients with known hepatitis B or hepatitis C positive serology and patients with hepatobiliary diseases such as chronic active liver disease.
- q. Use any biologics, such as anti-tumor necrosis factor, abaxipril, tuximab, or rituximab, within 3 months prior to the first dose.
- r. Enroll in any other clinical trial involving the off-label use of investigational drugs or devices, or enroll in any other type of medical research.
- s. Body mass index (BMI) less than 18.5kg/m2 or greater than 30 kg/m2.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Prospective Study of Niacin Sustained-release Capsules in the Treatment of Rheumatoid Arthritis Complicated With Dyslipidemia
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.
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- niacin sustained release capsules, Placebo
- Keywords
- Rheumatoid Arthritis (RA), niacin
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacin sustained release capsulesDrug
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Niacin | Experimental | The first and second stage: niacin sustained-release capsules orally for 3 months Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and 12 weeks
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start28 May 2025 (estimated)
- Primary completion3 Jan 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004725
- Sponsor's protocol ID
- Niacin RA
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Prospective Study of Niacin Sustained-release Capsules in the Treatment of Rheumatoid Arthritis Complicated With Dyslipidemia
- ClinicalTrials.gov ID
- NCT07004725
- Acronym / sponsor ID
- Niacin RA
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), niacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niacin | Experimental | Drug: niacin sustained release capsulesThe first and second stage: niacin sustained-release capsules orally for 3 months |
| Placebo | Placebo comparator | Drug: PlaceboThe first stage: placebo for 3 months, the second stage: niacin sustained release capsules for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niacin sustained release capsulesThe 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 | Drug | Niacin |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
Changes in the percentages and counts of T cell subsets assessed by flow cytometry.
Time frame: Baseline, 4 weeks and 12 weeks
Evaluating changes in the percentage of regular T cell subsets in peripheral blood before and after treatment by flow cytometry.
4 secondary outcomes
Changes in disease Activity Score in 28 joints (DAS28) assessed by physician.
Time frame: Baseline,12 weeks
Changes in the simplified disease activity index (SDAI) assessed by physician
Time frame: Baseline and 12 weeks
Changes in the clinical disease activity index (CDAI) assessed by physician
Time frame: Baseline and 12 weeks
ACR 20/50/70 response rate assessed by physician
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing niacin sustained release capsules in people with Rheumatoid Arthritis (RA), run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing He (010-88326666, hejing1105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the percentages and counts of T cell subsets assessed by flow cytometry. (time frame: Baseline, 4 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.