Hair Fall in Patients on Low Dose Methotrexate

Columbia Asia

Status: Unknown

Conditions: Methotrexate Adverse Reaction; Alopecia; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT02591823

IEC/2015/RP/18

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Healthy Controls

Description:

Healthy subject who accompanying patients to rheumatology OPD or healthy subjects who are staff at Columbia Asia Hospital,Bangalore.

Cases (patients on methotrexate)

Description:

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