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Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

NCT ID: NCT05082805

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-25

Study Completion Date

2022-12-31

Brief Summary

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This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.

The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.

Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Major patient (age ≥ 18 years)
* Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
* Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
* Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
* Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.

Exclusion Criteria

* Patient participating in an interventional study in rheumatology
* Patient with axial spondyloarthritis (for patients with PsA)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Pharma SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène HERMAN-DEMARS, MD

Role: STUDY_DIRECTOR

Nordic Pharma

René Marc FLIPO, Prof

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Cécile GAUJOUX-VIALA, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Nîmes

Emmanuelle DERNIS, Dr

Role: PRINCIPAL_INVESTIGATOR

CH Le Mans

Éric SENBEL, Dr

Role: PRINCIPAL_INVESTIGATOR

Marseille

Locations

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Nordic Pharma

Paris, , France

Site Status

Countries

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France

Other Identifiers

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STRATEGE 2

Identifier Type: -

Identifier Source: org_study_id