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Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis

12 novembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

85

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Altro: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Altri nomi:
  • b/tsDMARD: Adalimumab, Infliximab, Golimumab, Certolizumab pegol, Tocilizumab, Sarilumab, Etanercept, Anakinra, Filgotinib, Updacitinib, Tofacitinib, Baricitinib
Altro: 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.
Altro: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Altri nomi:
  • b/tsDMARD: Adalimumab, Infliximab, Golimumab, Certolizumab pegol, Tocilizumab, Sarilumab, Etanercept, Anakinra, Filgotinib, Updacitinib, Tofacitinib, Baricitinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of subjects without a clinical flare until week 24
Lasso di tempo: week 24
Proportion of subjects without a clinical flare
week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of subjects without a clinical flare
Lasso di tempo: week 48
Proportion of subjects without a clinical flare
week 48
Time to clinical flare (days)
Lasso di tempo: study period
Time to clinical flare (days)
study period
28 swollen joint count
Lasso di tempo: week 24
28 swollen joint count, scale 0 (best) - 28 (worse)
week 24
28 tender joint count
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: week 48
Proportion of patients in low disease activity or remission based on simplified disease activity index
week 48
Patient's global assessment
Lasso di tempo: week 24
Patient's global assessment, scale 0 (best) - 100 (worst)
week 24
Evaluator's global assessment
Lasso di tempo: week 24
Evaluator's global assessment, scale 0 (best) - 100 (worst)
week 24
C-reactive protein
Lasso di tempo: week 24
C-reactive protein, scale 0 (best) - infinite (worst)
week 24
Radiographic progression
Lasso di tempo: 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
Lasso di tempo: week 24
Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
week 24
World Health Organization Quality of Life Questionnaire
Lasso di tempo: week 24
World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
week 24
Morning stiffness
Lasso di tempo: week 24
Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
week 24
Fatigue
Lasso di tempo: week 24
Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical University of Vienna

Collaboratori

Medical University of Graz
Medical University Innsbruck
Hospital Hietzing
Krankenhaus Bruneck

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 marzo 2022

Completamento primario (Anticipato)

1 settembre 2024

Completamento dello studio (Anticipato)

1 settembre 2024

Date di iscrizione allo studio

Primo inviato

2 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2021

Primo Inserito (Effettivo)

15 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 novembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 novembre 2021

Ultimo verificato

1 novembre 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1389/2020

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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