Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— STRATEGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288520
• Other study ID #: STRATEGE
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: June 1, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of PersonnesFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 854
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	Nordic Pharma	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)	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)	Patients are included at the time of the change in the treatment of the RA and followed up to 6 months	No
Secondary	Patient's satisfaction using a 4-point verbal scale	Satisfaction will be assessed using a 4-point verbal scale.	6 months after inclusion	No
Secondary	Medical economic aspect (cost/benefit ratio)	The cost/benefit ratio of each therapeutic strategy will be described.	6 months after inclusion	No