Hair Fall in Patients on Low Dose Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02591823
• Other study ID #: IEC/2015/RP/18
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2015
• Last updated: January 13, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2016
• Source: Columbia Asia
• Contact: Sharath Kumar, MBBS,MD,DNB
• Phone: 9980094600
• Email: arthritisdoctor.in[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alopecia
• Arthritis
• Arthritis, Rheumatoid
• Methotrexate Adverse Reaction
• Rheumatoid Arthritis

Locations

Country	Name	City	State
India	Columbia Asia Hospitals	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Columbia Asia

Country where clinical trial is conducted

India, 

References & Publications (3)

Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gömör B, Van Den Bosch F, Nordström 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No