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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Healthy subject who accompanying patients to rheumatology OPD or healthy subjects who are staff at Columbia Asia Hospital,Bangalore. | ||
| Cases (patients on methotrexate) | 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
For Cases
For Controls
-Subjects should be above 18 years of age.
Exclusion Criteria:
For Cases
For Controls
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Cases will consist of consecutive patients diagnosed with rheumatoid arhtiritis in the rheumatology OPD of Columbia Asia hospitals,Bengaluru who are started on methotrexate.
Control population will consist of healthy volunteers (relatives of patients attending the rheumatology OPD or staff in the hospital)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharath Kumar, MBBS,MD,DNB | Contact | 9980094600 | arthritisdoctor.in@gmail.com | |
| Dhivya L, M.Sc,PGD | Contact | 9620256190 | trimuk236@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sharath Kumar, MBBS,MD,DNB | Columbia Asia Hospitals,Bangalore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Asia Hospitals | Recruiting | Bangalore | Karnataka | 560055 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21199463 | Background | Malaviya AN, Sharma A, Agarwal D, Kapoor S, Garg S, Sawhney S. Low-dose and high-dose methotrexate are two different drugs in practical terms. Int J Rheum Dis. 2010 Oct;13(4):288-93. doi: 10.1111/j.1756-185X.2010.01564.x. Epub 2010 Aug 16. | |
| 10888712 | Background | Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gomor B, Van Den Bosch F, Nordstrom D, Bjorneboe O, Dahl R, Horslev-Petersen K, Rodriguez De La Serna A, Molloy M, Tikly M, Oed C, Rosenburg R, Loew-Friedrich I. A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology (Oxford). 2000 Jun;39(6):655-65. doi: 10.1093/rheumatology/39.6.655. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
| 4256007 | Background | Hansen HH, Selawry OS, Holland JF, McCall CB. The variability of individual tolerance to methotrexate in cancer patients. Br J Cancer. 1971 Jun;25(2):298-305. doi: 10.1038/bjc.1971.38. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |