Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis
12. November 2021 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
85
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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
Andere Namen:
|
|
Sonstiges: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of subjects without a clinical flare until week 24
Zeitfenster: week 24
|
Proportion of subjects without a clinical flare
|
week 24
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of subjects without a clinical flare
Zeitfenster: week 48
|
Proportion of subjects without a clinical flare
|
week 48
|
|
Time to clinical flare (days)
Zeitfenster: study period
|
Time to clinical flare (days)
|
study period
|
|
28 swollen joint count
Zeitfenster: week 24
|
28 swollen joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
28 tender joint count
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: week 48
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 48
|
|
Patient's global assessment
Zeitfenster: week 24
|
Patient's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
Evaluator's global assessment
Zeitfenster: week 24
|
Evaluator's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
C-reactive protein
Zeitfenster: week 24
|
C-reactive protein, scale 0 (best) - infinite (worst)
|
week 24
|
|
Radiographic progression
Zeitfenster: 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
Zeitfenster: week 24
|
Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
|
week 24
|
|
World Health Organization Quality of Life Questionnaire
Zeitfenster: week 24
|
World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
|
week 24
|
|
Morning stiffness
Zeitfenster: week 24
|
Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
|
week 24
|
|
Fatigue
Zeitfenster: week 24
|
Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
|
week 24
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. März 2022
Primärer Abschluss (Voraussichtlich)
1. September 2024
Studienabschluss (Voraussichtlich)
1. September 2024
Studienanmeldedaten
Zuerst eingereicht
2. November 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. November 2021
Zuerst gepostet (Tatsächlich)
15. November 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. November 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. November 2021
Zuletzt verifiziert
1. November 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Autoimmunerkrankungen
- Gelenkerkrankungen
- Erkrankungen des Bewegungsapparates
- Rheumatische Erkrankungen
- Bindegewebserkrankungen
- Arthritis
- Arthritis, Rheuma
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Magen-Darm-Mittel
- Dermatologische Wirkstoffe
- Proteinkinase-Inhibitoren
- Tumor-Nekrose-Faktor-Inhibitoren
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
- Certolizumab Pegol
- Tofacitinib
- Antirheumatika
Andere Studien-ID-Nummern
- 1389/2020
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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