Rheumatoid ArthritisPhase 2NAM&RANCT06640309
The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
A Phase 2 study testing Nicotinamide Tablet and conventional synthetic antirheumatic drugs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
Trial summary
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Nicotinamide Tablet and conventional synthetic antirheumatic drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2023to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-65 years).
- Patients with a diagnosis of established rheumatoid arthritis.
- Patients presenting with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein levels (DAS-28-CRP) >3.2.
- Receiving stable regimen of one or more conventional disease modifying antirheumatic drugs for at least the past three months.
- Patients willing to sign an informed consent.
Who cannot join
- Patients with a known history of hypersensitivity or drug allergies to nicotinamide
- Patients receiving nicotinamide for any other indications.
- Receiving any dosage forms/ dosage regimen of vitamin B3 supplementation
- Receiving biologic disease modified antirheumatic drugs therapy.
- Impaired liver functions (liver transaminases level ≥ three times upper normal limits).
- Impaired kidney functions (estimated glomerular filtration rate (eGFR) < 30 ml/min)
- Pregnancy and lactation.
- Patients with other auto-immune diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo
Dalia Abdelmohsen, Professor, +20 100 1580007, d_mohsen@hotmail.com
Sara Raslan, Bachelor
About this study
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs.
Read the detailed description
Study design:
A prospective randomized controlled interventional parallel open label study.
Patient randomization:
All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either nicotinamide group or control group as follows:
- Nicotinamide group: consists of thirty-five patients who will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy.
- Control group: consists of thirty-five patients who will receive their conventional therapy only.
Methodology:
At baseline, the following will be obtained through patients' interview:
- Demographic data.
- Medical history and comorbidities.
- The disease activity; identified through patients' physical examination and serum C-Reactive Protein (CRP) levels as prerequisites for Disease Activity Score-28 (DAS-28-CRP).
- The disease duration.
- Current medications history.
Evaluation of the efficacy and safety of nicotinamide will be assessed at baseline and after three months through:
- Blood sampling will be collected from patients for serum CRP , Erythrocyte sedimentation rate (ESR) and analysis of Interleukin-10 .These samples will be directly centrifuged at 1000 x g for fifteen minutes and then plasma will be separated and collected in capped test tubes, then will be stored at -80 °C until analysis. Interleukin-10 serum level will be measured using an Enzyme Linked Immunosorbent Assay (ELISA) technique.
- Disease Activity will be calculated based on tender joint count (TJC) and swollen joint count (SJC) following the assessment of twenty-eight joints, serum CRP level, and the patient's global health assessment (PGA) on a scale from zero to one hundred. The score will be calculated using the following equation: DAS-28-CRP = 0.56* √(TJC28) + 0.28* √(SJC28) + 0.36*ln (CRP + 1) +0.014*(PGA) + 0.96
- Patient's QOL will be assessed by using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
- Patients will be educated about the side effects and/or adverse effects of nicotinamide, where, safety and tolerability will be monitored by reporting the incidence of any side effect and /or adverse effect such as stomach upset, flatulence, dizziness, headache, and rash.
Blood samples will be collected for complete blood count (CBC), alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine (Scr.) levels analysis to monitor adverse effects of conventional synthetic disease-modified antirheumatic (csDMARDs) drugs and nicotinamide.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Nicotinamide Tablet, conventional synthetic antirheumatic drugs
- Keywords
- Rheumatoid Arthritis, Nicotinamide, Quality of life, DAS-28
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide TabletDrug
Nicotinamide is anti-inflammatory and antioxidant.
conventional synthetic antirheumatic drugsDrug
methotrexate- leflunomide- sulfasalazine- hydroxychloroquine
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide group | Experimental | Patients will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy for three months. Receives: Drug: Nicotinamide Tablet; Drug: conventional synthetic antirheumatic drugs |
| control group | Active comparator | Patients will receive their conventional therapy only. Receives: Drug: conventional synthetic antirheumatic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity assessment using DAS-28 -CRP
DAS-28-CRP at baseline and at end of study, which will be calculated based on tender joint count (TJC) and swollen joint count (SJC) following the assessment of twenty-eight joints (figure 1) , serum CRP level, and the patient's global health assessment (PGA) on a scale from zero to one hundred. The score will be calculated using the following equation: (CASTREJÓN et al., 2010) DAS-28-CRP = 0.56* √(TJC28) + 0.28* √(SJC28) + 0.36*ln (CRP + 1) +0.014*(PGA) + 0.96
Measured: At baseline and after three months.
Secondary outcomes (4)
Serum Interleukin-10
Venous blood samples will be collected from patients at baseline and at the end of the study (three months). Blood samples will be directly centrifuged at 1000 x g for fifteen minutes and then plasma will be separated and collected in capped test tubes, then will be stored at -80 °C until analysis. Interleukin-10 serum level will be measured at baseline and after three months of study period using an ELISA technique according to the manufacturer's protocol.
Measured: At baseline and after three months.
Detection of any change in inflammatory markers
Serum C-reactive protein and Erythrocyte sedimentation rate.
Measured: At baseline and after three months.
Quality of Life (QOL) questionnaire
Patient's QOL will be assessed by using the Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline and after three months. It assesses patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities
Measured: At baseline and after three months.
Safety and tolerability of Nicotinamide
Patients will be educated about the side effects and/or adverse effects of nicotinamide, where, safety and tolerability will be monitored by reporting the incidence of any side effect and /or adverse effect such as stomach upset, flatulence, dizziness, headache, and rash.
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Dec 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- A prospective randomized controlled interventional parallel open label study.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara ahmed raslan, Ain Shams University
- Investigators
- Lamia El wakeel, Professor, Study director, Professor and head of department of Clinical Pharmacy at Faculty of Pharmacy Ain Shams UniversityMay Ahmed, Asst. professor, Study director, Assistant professor of Clinical Pharmacy, Ain Shams University-Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640309
- Sponsor's protocol ID
- NAM/RA/1223
- Acronym
- NAM&RA
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamat JP, Devasagayam TP. Nicotinamide (vitamin B3) as an effective antioxidant against oxidative damage in rat brain mitochondria. Redox Rep. 1999;4(4):179-84. doi: 10.1179/135100099101534882.
PubMed 10658823Miesel R, Kurpisz M, Kroger H. Modulation of inflammatory arthritis by inhibition of poly(ADP ribose) polymerase. Inflammation. 1995 Jun;19(3):379-87. doi: 10.1007/BF01534394.
PubMed 7628865Ungerstedt JS, Blomback M, Soderstrom T. Nicotinamide is a potent inhibitor of proinflammatory cytokines. Clin Exp Immunol. 2003 Jan;131(1):48-52. doi: 10.1046/j.1365-2249.2003.02031.x.
PubMed 12519385
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT06640309
- Acronym / sponsor ID
- NAM&RA / NAM/RA/1223
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Nicotinamide, Quality of life, DAS-28
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs.
Detailed description
Study design:
A prospective randomized controlled interventional parallel open label study.
Patient randomization:
All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either nicotinamide group or control group as follows:
- Nicotinamide group: consists of thirty-five patients who will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy.
- Control group: consists of thirty-five patients who will receive their conventional therapy only.
Methodology:
At baseline, the following will be obtained through patients' interview:
- Demographic data.
- Medical history and comorbidities.
- The disease activity; identified through patients' physical examination and serum C-Reactive Protein (CRP) levels as prerequisites for Disease Activity Score-28 (DAS-28-CRP).
- The disease duration.
- Current medications history.
Evaluation of the efficacy and safety of nicotinamide will be assessed at baseline and after three months through:
- Blood sampling will be collected from patients for serum CRP , Erythrocyte sedimentation rate (ESR) and analysis of Interleukin-10 .These samples will be directly centrifuged at 1000 x g for fifteen minutes and then plasma will be separated and collected in capped test tubes, then will be stored at -80 °C until analysis. Interleukin-10 serum level will be measured using an Enzyme Linked Immunosorbent Assay (ELISA) technique.
- Disease Activity will be calculated based on tender joint count (TJC) and swollen joint count (SJC) following the assessment of twenty-eight joints, serum CRP level, and the patient's global health assessment (PGA) on a scale from zero to one hundred. The score will be calculated using the following equation: DAS-28-CRP = 0.56* √(TJC28) + 0.28* √(SJC28) + 0.36*ln (CRP + 1) +0.014*(PGA) + 0.96
- Patient's QOL will be assessed by using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
- Patients will be educated about the side effects and/or adverse effects of nicotinamide, where, safety and tolerability will be monitored by reporting the incidence of any side effect and /or adverse effect such as stomach upset, flatulence, dizziness, headache, and rash.
Blood samples will be collected for complete blood count (CBC), alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine (Scr.) levels analysis to monitor adverse effects of conventional synthetic disease-modified antirheumatic (csDMARDs) drugs and nicotinamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective randomized controlled interventional parallel open label study.
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide group | Experimental | Drug: Nicotinamide Tablet, Drug: conventional synthetic antirheumatic drugsPatients will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy for three months. |
| control group | Active comparator | Drug: conventional synthetic antirheumatic drugsPatients will receive their conventional therapy only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (18-65 years).
- Patients with a diagnosis of established rheumatoid arthritis.
- Patients presenting with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein levels (DAS-28-CRP) >3.2.
- Receiving stable regimen of one or more conventional disease modifying antirheumatic drugs for at least the past three months.
- Patients willing to sign an informed consent.
Key exclusion criteria (8 listed)
- Patients with a known history of hypersensitivity or drug allergies to nicotinamide
- Patients receiving nicotinamide for any other indications.
- Receiving any dosage forms/ dosage regimen of vitamin B3 supplementation
- Receiving biologic disease modified antirheumatic drugs therapy.
- Impaired liver functions (liver transaminases level ≥ three times upper normal limits).
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 |
|---|---|---|
| Nicotinamide TabletNicotinamide is anti-inflammatory and antioxidant. | Drug | Nicotinamide group |
| conventional synthetic antirheumatic drugsmethotrexate- leflunomide- sulfasalazine- hydroxychloroquine | Drug | Nicotinamide group, control group |
Primary outcome
Disease severity assessment using DAS-28 -CRP
Time frame: At baseline and after three months.
DAS-28-CRP at baseline and at end of study, which will be calculated based on tender joint count (TJC) and swollen joint count (SJC) following the assessment of twenty-eight joints (figure 1) , serum CRP level, and the patient's global health assessment (PGA) on a scale from zero to one hundred. The score will be calculated using the following equation: (CASTREJÓN et al., 2010) DAS-28-CRP = 0.56* √(TJC28) + 0.28* √(SJC28) + 0.36*ln (CRP + 1) +0.014*(PGA) + 0.96
4 secondary outcomes
Serum Interleukin-10
Time frame: At baseline and after three months.
Detection of any change in inflammatory markers
Time frame: At baseline and after three months.
Quality of Life (QOL) questionnaire
Time frame: At baseline and after three months.
Safety and tolerability of Nicotinamide
Time frame: Three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 10658823Kamat JP, Devasagayam TP. Nicotinamide (vitamin B3) as an effective antioxidant against oxidative damage in rat brain mitochondria. Redox Rep. 1999;4(4):179-84. doi: 10.1179/135100099101534882.
- Background: PubMed 7628865Miesel R, Kurpisz M, Kroger H. Modulation of inflammatory arthritis by inhibition of poly(ADP ribose) polymerase. Inflammation. 1995 Jun;19(3):379-87. doi: 10.1007/BF01534394.
- Background: PubMed 12519385Ungerstedt JS, Blomback M, Soderstrom T. Nicotinamide is a potent inhibitor of proinflammatory cytokines. Clin Exp Immunol. 2003 Jan;131(1):48-52. doi: 10.1046/j.1365-2249.2003.02031.x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lamia El wakeel, Professor study director
Professor and head of department of Clinical Pharmacy at Faculty of Pharmacy Ain Shams University
May Ahmed, Asst. professor study director
Assistant professor of Clinical Pharmacy, Ain Shams University-Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Tablet and conventional synthetic antirheumatic drugs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
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 8 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara A. Raslan, Bachelor (+20 1020145174, Sarah.raslan@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease severity assessment using DAS-28 -CRP (time frame: At baseline and after three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640309, which also lists 3 linked publications.
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 16 Oct 2024.