NCT05082805

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

June 24, 2019

Last Update Submit

October 14, 2021

Conditions

Rheumatoid ArthritisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Main criteria analysis

    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

    12 and 24 months after inclusion

  • Disease outcome

    12 and 24 months after inclusion

  • Patient adherence to treatment

    12 and 24 months after inclusion

  • Fatigue and pain

    12 and 24 months after inclusion

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient participating in an interventional study in rheumatology
  • Patient with axial spondyloarthritis (for patients with PsA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordic Pharma

Paris, 75007, France

Location

Related Publications (1)

  • Gaujoux-Viala C, Dernis E, Senbel E, Herman-Demars H, Becker J, Flipo RM. Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study. Rheumatol Ther. 2026 Feb;13(1):157-177. doi: 10.1007/s40744-025-00806-1. Epub 2025 Dec 3.

    PMID: 41335306DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, Psoriatic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Study Officials

  • Hélène HERMAN-DEMARS, MD

    Nordic Pharma

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2019

First Posted

October 19, 2021

Study Start

February 25, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)