Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nordic Pharma

Paris, 75007, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)

Time frame: 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 outcomes

Patient's satisfaction using a 4-point verbal scale

Time frame: 6 months after inclusion

Satisfaction will be assessed using a 4-point verbal scale.
Medical economic aspect (cost/benefit ratio)

Time frame: 6 months after inclusion

The cost/benefit ratio of each therapeutic strategy will be described.

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Official study title

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

Acronym: STRATEGE

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 11, 2014
Registry last updated: Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed