NCT02591823

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

October 28, 2015

Last Update Submit

January 13, 2016

Conditions

AlopeciaRheumatoid ArthritisMethotrexate Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • 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.

    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

  • +6 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Asia Hospitals

Bangalore, Karnataka, 560055, India

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21199463BACKGROUND

  • 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.

    PMID: 10888712BACKGROUND

  • 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.

    PMID: 4256007BACKGROUND

MeSH Terms

Conditions

AlopeciaArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sharath Kumar, MBBS,MD,DNB

    Columbia Asia Hospitals,Bangalore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharath Kumar, MBBS,MD,DNB

CONTACT

9980094600arthritisdoctor.in@gmail.com

Dhivya L, M.Sc,PGD

CONTACT

9620256190trimuk236@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Rheumatologist

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

IN(1)