Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

Methotrexate Clinical Trial

— METHO-PR  

Official title:

Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107299
• Other study ID #: PI2016_843_0006
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: April 10, 2017
• Start date: July 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Vincent GOEB, PhD
• Phone: +33322668259
• Email: goeb.vincent[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.

The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.

For this purpose, 3 methods of communication have been put in place to encourage adherence:

usual care by the rheumatologist, sms sending or pharmaceutical maintenance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.

• Consenting Patient

• Literate French-speaking patient,

• Patient with a mobile phone

• Patient affiliated to a social security scheme

Exclusion Criteria:

• Patient not managing his own treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Methotrexate
• Polyarthritis; Rheumatoid

Intervention

Other:
• Communication methods to encourage adherence
Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.		10 months