Hair Fall in Patients on Low Dose Methotrexate

NCT ID: NCT02591823

Last Updated: 2016-01-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-05-31

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.

Detailed Description

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Conditions

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Alopecia Rheumatoid Arthritis Methotrexate Adverse Reaction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia Asia

OTHER

Sponsor Role lead

Responsible Party

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Dr.Sharath Kumar

Consultant Rheumatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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India

Central Contacts

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Sharath Kumar, MBBS,MD,DNB

Role: CONTACT

9980094600

Dhivya L, M.Sc,PGD

Role: CONTACT

9620256190

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.

Reference Type BACKGROUND
PMID: 21199463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10888712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4256007 (View on PubMed)

Other Identifiers

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IEC/2015/RP/18

Identifier Type: -

Identifier Source: org_study_id

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