Clinical trial NCT02288520: Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis
Official title: Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Methotrexate
Therapeutic strategy
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 854
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis (RA) patients with clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA will be asked to participate from RA treatment change (inclusion visit) up to 6 months after inclusion.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)
timeFrame: Patients are included at the time of the change in the treatment of the RA and followed up to 6 months
Secondary outcomes:
measure: Patient's satisfaction using a 4-point verbal scale
timeFrame: 6 months after inclusion
measure: Medical economic aspect (cost/benefit ratio)
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: Nordic Pharma
name: Hélène HERMAN DEMARS, MD
role: STUDY_DIRECTOR
References:
citation: Gaujoux-Viala C, Hudry C, Zinovieva E, Herman-Demars H, Flipo RM. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE. Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.