Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02288520
• Lead Sponsor: Nordic Pharma SAS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Status Verified: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 854

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nordic Pharma; 🇫🇷 Paris, France