NCT02591823Unknown不适用
Observational Study of Hair Fall in Rheumatoid Arthritis Patients Treated With Low Dose Methotrexate
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean change in number of hair strands obtained by the hair pull test at the baseline and at 3 weeks among RA patients on methotrexate in comparison to the mean change in the same number among controls.
研究概览
简要总结
Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side effect profile very different from that seen with high dose methotrexate used in oncology. Hair fall has been found to occur in high dose methotrexate but there is no data regarding the same when methotrexate is used in low dose.Thus this observational case control study is being undertaken to determine whether rheumatoid arthritis patients really need to be concerned about hair fall when on low dose methotrexate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects should be above 18 years of age.
- •Diagnosed with rheumatoid arthritis and fulfilling the ACR EULAR 2010 criteria.
- •Should be initiated on methotrexate
- •Willing to follow up
- •For Controls
- •Subjects should be above 18 years of age.
排除标准
- •Subjects with prior exposure to methotrexate in the last 6 months
- •Subjects suffering from Thyroid (hypothyroidism)
- •Subjects on leflunomide, or having received leflunomide in the last 6 months
- •Subjects currently on cyclophosphamide or having received cyclophosphamide in the last 3 months.
- •Subjects on psychiatric treatment or depression illness.
- •Subjects who have overlap with other rheumatological disorders which can cause hair fall.
- •Subjects in 1-5 months of post-partum or post-natal period.
- •Subjects with female pattern baldness
- •Subjects with androgenetic alopecia
- •Subjects with alopecia aereta
- •Subjects with other scalp conditions which can predispose to hair fall
- •For Controls
- •Subjects having any family history of alopecia.
- •Subjects suffering from thyroid.
- •Subjects having any history of anemia.
- •Subjects under 1-5 months of post-partum or post-natal period.
- •Subjects on medications which can cause hair fall.
- •Subjects on methotrexate for other reasons.
- •Subjects with female pattern baldness
- •Subjects with androgenetic alopecia
- •Subjects with alopecia aereta
- •Subjects with other scalp conditions which can predispose to hair fall
结局指标
主要结局
Mean change in number of hair strands obtained by the hair pull test at the baseline and at 3 weeks among RA patients on methotrexate in comparison to the mean change in the same number among controls.
时间窗: 3 weeks
Mean change in number of hair strands obtained by the hair pull test at the start of the trial and at 3 weeks among rheumatoid arthritis patients on methotrexate in comparison to the mean change in the same number among health controls
次要结局
- Mean difference in number of subjects having an abnormal hair pull test at baseline and at 2 months in patients with RA patients on methotrexate and compare the same with the mean difference.(2 months)
- Difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at 3 months between rheumatoid arthritis patients on methotrexate and healthy controls.(3 Months)
- Determine the difference in number of subjects having an abnormal hair pull test at baseline in patients with RA patients on methotrexate and controls.(0 month)
- Mean change in number of hair strands obtained by the hair pull test at the start of the trial and at 3 months among RA patients on methotrexate in comparison to the mean change in the same number among control.(3 Months)
- Mean difference in number of subjects having an abnormal hair pull test (defined as > 5 hairs) at baseline and at 3 weeks in patients with RA on methotrexate and compare the same with the mean difference.(3 weeks)
- Mean difference in number of subjects having an abnormal hair pull test at baseline and at 3 months in patients with RA patients on methotrexate and compare the same with the mean difference.(3 months)
- Difference in number of subjects having an anagen hair among the hair obtained by hair pull test (normal = 0) at 2 months between RA patients on methotrexate and controls.(2 months)
- Difference in the mean number of hair obtained at the time of inclusion in the study among rheumatoid arthritis patients and health controls(0 month)
- Mean change in number of hair strands obtained by the hair pull test at baseline and at 2 months among RA patients on methotrexate in comparison with mean change in the same number among controls.(2 months)
- Difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at 3 weeks between RA patients on methotrexate and controls.(3 weeks)
- Determine the difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at inclusion in the study between RA patients on methotrexate and healthy controls.(0 month)
研究者
Dr.Sharath Kumar
Consultant Rheumatologist
Columbia Asia
研究点 (1)
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