Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis
12. november 2021 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
85
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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
Andre navne:
|
|
Andet: 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of subjects without a clinical flare until week 24
Tidsramme: week 24
|
Proportion of subjects without a clinical flare
|
week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of subjects without a clinical flare
Tidsramme: week 48
|
Proportion of subjects without a clinical flare
|
week 48
|
|
Time to clinical flare (days)
Tidsramme: study period
|
Time to clinical flare (days)
|
study period
|
|
28 swollen joint count
Tidsramme: week 24
|
28 swollen joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
28 tender joint count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: week 48
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 48
|
|
Patient's global assessment
Tidsramme: week 24
|
Patient's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
Evaluator's global assessment
Tidsramme: week 24
|
Evaluator's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
C-reactive protein
Tidsramme: week 24
|
C-reactive protein, scale 0 (best) - infinite (worst)
|
week 24
|
|
Radiographic progression
Tidsramme: 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
Tidsramme: week 24
|
Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
|
week 24
|
|
World Health Organization Quality of Life Questionnaire
Tidsramme: week 24
|
World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
|
week 24
|
|
Morning stiffness
Tidsramme: week 24
|
Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
|
week 24
|
|
Fatigue
Tidsramme: week 24
|
Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
|
week 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. marts 2022
Primær færdiggørelse (Forventet)
1. september 2024
Studieafslutning (Forventet)
1. september 2024
Datoer for studieregistrering
Først indsendt
2. november 2021
Først indsendt, der opfyldte QC-kriterier
12. november 2021
Først opslået (Faktiske)
15. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Gigt
- Gigt, reumatoid
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Dermatologiske midler
- Proteinkinasehæmmere
- Tumornekrosefaktorhæmmere
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
- Certolizumab Pegol
- Tofacitinib
- Antirheumatiske midler
Andre undersøgelses-id-numre
- 1389/2020
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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