Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

NCT02288520 | Completed

• 1 other identifier: STRATEGE
• Study Type: observational
• Target: 854
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Methotrexate; Therapeutic strategy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Patient's satisfaction using a 4-point verbal scale

  6 months after inclusion

• Medical economic aspect (cost/benefit ratio)

  6 months after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Nordic Pharma

Paris, 75007, France

Location

Related Publications (1)

• 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.

  PMID: 33774669 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Hélène HERMAN DEMARS, MD

  Nordic Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2015-10

Locations

FR (1)