Hair Fall in Patients on Low Dose Methotrexate

Study Overview
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Brief Summary
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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.

Official Title
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Observational Study of Hair Fall in Rheumatoid Arthritis Patients Treated With Low Dose Methotrexate

Conditions
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Alopecia, Rheumatoid Arthritis, Methotrexate Adverse Reaction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Cases 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. Exclusion Criteria: For Cases 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Controls<br>Healthy subject who accompanying patients to rheumatology OPD or healthy subjects who are staff at Columbia Asia Hospital,Bangalore. | |
| Cases (patients on methotrexate)<br>Subjects attending the rheumatology OPD of Columbia Asia hospitals bengaluru, who are diagnosed as having Rheumatoid arthritis and fulfill the ACR/ EULAR 2010 classification criteria for rheumatoid arthritis and are started on low dose methotrexate will included as cases | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 2 months in patients with RA patients on methotrexate and compare the same with the mean difference. |  | 2 months | 
| 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 the hair obtained by hair pull test (normal = 0) at 3 weeks between RA patients on methotrexate and controls. |  | 3 weeks | 
| 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 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 | 
| 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 | 
| 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 | 
| 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 |