Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis
12 novembre 2021 mis à jour par: Dr. Peter Mandl, Medical University of Vienna
Screening for Flare After Discontinuation of Biological/Targeted Synthetic Disease Modifying Anti-rheumatic Drug (b/tsDMARD) in Rheumatoid Arthritis
To evaluate whether stringent follow-up consisting of combined laboratory and ultrasound surveillance is superior to clinical monitoring alone to maintain clinical remission in rheumatoid arthritis.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
Randomized, controlled, parallel-group, multi-centre study in which patients with rheumatoid arthritis treated with biological/targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) in mono- or combination therapy with conventional synthetic disease modifying antirheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months with low disease activity or remission will receive an power Doppler musculoskeletal ultrasound examination (PDUS) and monitoring of C-reactive protein (CRP) levels at baseline and several timepoints within a 24 month study period (primary endpoint) and within a 48 month long-term extension.
At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.
Further stratification for remission vs. low disease activity and mono- vs combination therapy will be implemented in the randomisation process.
In arm A, CRP and PDUS information will be made available to the clinical assessors who, at each time-point will use this information along with that from clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
In arm B the results of CRP and PDUS will be recorded but will not be made available to the clinical assessor who will have to identify clinical flares according to predefined criteria based on information from the clinical examination only.
Type d'étude
Interventionnel
Inscription (Anticipé)
85
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Patients with rheumatoid arthritis classified by the American College of Rheumatology/European League Against Rheumatism classification criteria
- biological disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) treatment in monotherapy or in combination therapy with conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months. Previous extension of bDMARD or tsDMARD interval will also be accepted. bDMARDs and tsDMARDs will include all currently available originator and biosimilar compounds, with the exception of rituximab and its biosimilar compounds
- No swollen joint by 28-joint count at baseline, and screening
- C-reactive protein of ≤0.5mg/dL at baseline AND history of C-reactive protein >0,5mg/dl related to rheumatoid arthritis activity
- Clinical disease activity index ≤10
- Shared decision between patient and physician to attempt b/tsDMARD withdrawal
- Willing and able to understand and follow the study procedures
- Written informed consent
- Female and male subjects aged ≥ 18 years
Exclusion Criteria:
- History of or current extra-articular manifestation of rheumatoid arthritis, with exception of rheumatoid nodules
- Systemic glucocorticoid treatment in the past 3 months
- Intraarticular injection with glucocorticoids in the past 1 month
- Joint replacement surgery other than total knee or hip arthroplasty or complete joint destruction
- Power Doppler signal ≥2 in any assessed joint and/or tendon at screening or baseline
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Assisted monitoring
In the Assisted monitoring arm, C-reactive protein and musculoskeletal ultrasound information will be made available to the clinical assessors who, at each time-point will use this information, along with information from the clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Autres noms:
|
|
Autre: Clinical monitoring
In the Clinical monitoring arm, the results of C-reactive protein and musculoskeletal ultrasound information will be recorded but will not be made available to the clinical assessor who at each time-point will make the decision on whether the patient is experiencing or has experienced a clinical flare according to predefined criteria based on information from the clinical examination.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of subjects without a clinical flare until week 24
Délai: week 24
|
Proportion of subjects without a clinical flare
|
week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of subjects without a clinical flare
Délai: week 48
|
Proportion of subjects without a clinical flare
|
week 48
|
|
Time to clinical flare (days)
Délai: study period
|
Time to clinical flare (days)
|
study period
|
|
28 swollen joint count
Délai: week 24
|
28 swollen joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
28 tender joint count
Délai: week 24
|
28 tender joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
Délai: week 24
|
Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
|
week 24
|
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
Délai: week 24
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 24
|
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
Délai: week 48
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 48
|
|
Patient's global assessment
Délai: week 24
|
Patient's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
Evaluator's global assessment
Délai: week 24
|
Evaluator's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
C-reactive protein
Délai: week 24
|
C-reactive protein, scale 0 (best) - infinite (worst)
|
week 24
|
|
Radiographic progression
Délai: at week 48 weeks from baseline
|
change in Sharp Van der Heijde score, scale 0 (best) - 488 (worse)
|
at week 48 weeks from baseline
|
|
Health Assessment Questionnaire Disability Index
Délai: week 24
|
Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
|
week 24
|
|
World Health Organization Quality of Life Questionnaire
Délai: week 24
|
World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
|
week 24
|
|
Morning stiffness
Délai: week 24
|
Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
|
week 24
|
|
Fatigue
Délai: week 24
|
Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
|
week 24
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 mars 2022
Achèvement primaire (Anticipé)
1 septembre 2024
Achèvement de l'étude (Anticipé)
1 septembre 2024
Dates d'inscription aux études
Première soumission
2 novembre 2021
Première soumission répondant aux critères de contrôle qualité
12 novembre 2021
Première publication (Réel)
15 novembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 novembre 2021
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Arthrite
- Arthrite, rhumatoïde
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires non stéroïdiens
- Analgésiques, non narcotiques
- Agents anti-inflammatoires
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents gastro-intestinaux
- Agents dermatologiques
- Inhibiteurs de protéine kinase
- Inhibiteurs du facteur de nécrose tumorale
- Étanercept
- Adalimumab
- Infliximab
- Golimumab
- Certolizumab Pégol
- Tofacitinib
- Agents antirhumatismaux
Autres numéros d'identification d'étude
- 1389/2020
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .