Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis (STRATEGE)

June 1, 2016 updated by: Nordic Pharma SAS

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

854

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75007
        • Nordic Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Patients are included at the time of the change in the treatment of the RA and followed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after inclusion
Medical economic aspect (cost/benefit ratio)
Time Frame: 6 months after inclusion
The cost/benefit ratio of each therapeutic strategy will be described.
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Pharma SAS

Investigators

  • Study Director: Hélène HERMAN DEMARS, MD, Nordic Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRATEGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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