Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02288520

Acronym

STRATEGE

Enrollment

854

Registered

2014-11-11

Start date

2014-09-30

Completion date

2016-03-31

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Methotrexate, Therapeutic strategy

Brief summary

This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors. The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patient, ambulatory, seen in a rheumatology consultation. * With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy. * With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA . * Informed about the computer processing of their medical data and their right of access and correction.

Exclusion criteria

* Patient not treated with methotrexate for their RA. * Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate . * Participating in a clinical trial in rheumatology.

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)	Patients are included at the time of the change in the treatment of the RA and followed up to 6 months	The distribution of the various therapeutic options will be described overall. Their impact on the progression of the RA will be assessed at 6 months according to the EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) score during the study)

Secondary

Measure	Time frame	Description
Patient's satisfaction using a 4-point verbal scale	6 months after inclusion	Satisfaction will be assessed using a 4-point verbal scale.
Medical economic aspect (cost/benefit ratio)	6 months after inclusion	The cost/benefit ratio of each therapeutic strategy will be described.

Countries

France

Outcome results