- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05082805
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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-
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Paris, Frankrike, 75007
- Nordic Pharma
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
Tidsramme: 12 months after inclusion
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Not provided as Outcome 1 is blinded
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12 months after inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Main criteria analysis
Tidsramme: 24 months after inclusion
|
Same Outcome 1, but at 24 month.
This outcome is blinded too.
|
24 months after inclusion
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Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
Tidsramme: 12 and 24 months after inclusion
|
delays, changes in dosage, changes in the route of administration, reasons for adaptations ...
|
12 and 24 months after inclusion
|
Disease outcome
Tidsramme: 12 and 24 months after inclusion
|
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
Tidsramme: 12 and 24 months after inclusion
|
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
Tidsramme: 12 and 24 months after inclusion
|
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
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Functional capacity (Health Assessment Questionnaire (HAQ))
Tidsramme: 12 and 24 months after inclusion
|
This questionnaire is completed by patients at baseline, 12 months and 24 months.
|
12 and 24 months after inclusion
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Cross-perception (doctor / patient) about participation in the "shared medical decision"
Tidsramme: 12 and 24 months after inclusion
|
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
Tidsramme: 12 and 24 months after inclusion
|
The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians)
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12 and 24 months after inclusion
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Hélène HERMAN-DEMARS, MD, Nordic Pharma
- Hovedetterforsker: René Marc FLIPO, Prof, CHRU Lille
- Hovedetterforsker: Cécile GAUJOUX-VIALA, Dr, CHU Nîmes
- Hovedetterforsker: Emmanuelle DERNIS, Dr, CH Le Mans
- Hovedetterforsker: Éric SENBEL, Dr, Marseille
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Hudsykdommer, Papulosquamous
- Spinal sykdommer
- Beinsykdommer
- Spondylarthropatier
- Spondylartritt
- Spondylitt
- Psoriasis
- Leddgikt
- Leddgikt, revmatoid
- Leddgikt, psoriasis
Andre studie-ID-numre
- STRATEGE 2
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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