The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Disease severity assessment using DAS-28 -CRP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Nicotinamide group
Patients will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy for three months.
干预措施: Nicotinamide Tablet (Drug)
Nicotinamide group
Patients will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy for three months.
干预措施: conventional synthetic antirheumatic drugs (Drug)
control group
Patients will receive their conventional therapy only.
干预措施: conventional synthetic antirheumatic drugs (Drug)
结局指标
主要结局
Disease severity assessment using DAS-28 -CRP
时间窗: 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
次要结局
- Serum Interleukin-10(At baseline and after three months.)
- Detection of any change in inflammatory markers(At baseline and after three months.)
- Quality of Life (QOL) questionnaire(At baseline and after three months.)
- Safety and tolerability of Nicotinamide(Three months.)
研究者
Sara ahmed raslan
clinical pharmacist at Ain Shams University Hospitals
Ain Shams University