Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis (STRATEGE2)

Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• France
  • Paris, France, 75007
    • Nordic Pharma

Participation Criteria

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

RA or PsA patient undergoing treatment with MTX for at least 3 months and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease will be asked to participate from bDMARD or tsDMARD treatment introduction (inclusion visit) up to 24 months after inclusion.

Description

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)

Study Plan

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
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.	Not provided as Outcome 1 is blinded	12 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main criteria analysis	Same Outcome 1, but at 24 month. This outcome is blinded too.	24 months after inclusion
Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids	delays, changes in dosage, changes in the route of administration, reasons for adaptations ...	12 and 24 months after inclusion
Disease outcome	disease activity (Disease Activity Score DAS28 and Disease Activity in PSoriatic Arthritis DAPSA)), percentage of patients in remission, quality of Life (Dermatology Life Quality Index (DLQI))	12 and 24 months after inclusion
Patient adherence to treatment	The variation of patients' adherence to antirheumatic treatments evaluated by the Compliance Questionnaire for Rhumatology (CQR19).	12 and 24 months after inclusion
Fatigue and pain	Visual Analog Scale (VAS) anchored by 2 verbal descriptors, one for each symptom extreme : 0 (no fatigue, no pain) to 10 (maximum fatigue, maximum pain).	12 and 24 months after inclusion
Functional capacity (Health Assessment Questionnaire (HAQ))	This questionnaire is completed by patients at baseline, 12 months and 24 months.	12 and 24 months after inclusion
Cross-perception (doctor / patient) about participation in the "shared medical decision"	This outcome is based on 2 mirror questions (one asked to the physician and on to the patient). They are asked if the decision to adapt the therapeutic decision is a "shared medical decision". Five answers are possible from "fully" to "not at all".	12 and 24 months after inclusion
Care path at the end of the visit	The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians)	12 and 24 months after inclusion

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma; Principal Investigator: René Marc FLIPO, Prof, CHRU Lille; Principal Investigator: Cécile GAUJOUX-VIALA, Dr, CHU Nîmes; Principal Investigator: Emmanuelle DERNIS, Dr, CH Le Mans; Principal Investigator: Éric SENBEL, Dr, Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic
• Other Study ID Numbers: STRATEGE 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No