Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2015-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy Controls
Healthy subject who accompanying patients to rheumatology OPD or healthy subjects who are staff at Columbia Asia Hospital,Bangalore.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Columbia Asia
OTHER
Responsible Party
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Dr.Sharath Kumar
Consultant Rheumatologist
Principal Investigators
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Sharath Kumar, MBBS,MD,DNB
Role: PRINCIPAL_INVESTIGATOR
Columbia Asia Hospitals,Bangalore
Locations
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Columbia Asia Hospitals
Bangalore, Karnataka, India
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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IEC/2015/RP/18
Identifier Type: -
Identifier Source: org_study_id
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