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

Rheumatoid Arthritis Clinical Trial

— STRATEGE2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082805
• Other study ID #: STRATEGE 2
• Status: Active, not recruiting
• Start date: February 25, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• 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	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	Main criteria analysis	Same Outcome 1, but at 24 month. This outcome is blinded too.	24 months after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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