Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis (IMAGINE-RA)

Does an MRI-guided Treatment Strategy Reduce Disease Activity and Progression in Patients With Rheumatoid Arthritis (RA): a Randomised Controlled Trial

The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).

Studie Overzicht

Gedetailleerde beschrijving

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Patients typically experience pain, functional impairment and reduced quality of life, and are at risk of developing progressive joint damage. The disease primarily affects the small joints of the hands and feet. The current treatment strategy involves early and intensive treatment with close clinical follow up, which attempts to control the disease and avoid inflammation and thereby prevent pain, improve functional level and avoid joint damage. It is therefore important for optimal treatment of RA patients that methods used for diagnosis, disease monitoring and prognostication are highly sensitive. Erosive joint damage occurs early in the disease. Joint deformity is irreversible and causes serious functional impairment. Early and intensive treatment with close monitoring of the inflammation can slow the destructive disease and prevent function loss. However, it has been demonstrated that patients who are shown by conventional clinical and biochemical examination to have low disease activity or to be in remission can still have progressive joint damage. This demonstrates that current clinical/biochemical methods used in daily clinical practice are not sufficiently sensitive and other methods are required for the monitoring of disease activity and prognostication.

The presence of erosions (shown by X-ray examination) as well as anti-cyclic citrullinated peptide (anti-CCP) antibodies and bone marrow oedema (osteitis) on magnetic resonance imaging (MRI), are all independent predictors of subsequent radiographic progression. Bone marrow oedema has been shown to be the strongest independent predictor in early RA and MRI therefore has significant prognostic value.

It is therefore possible that supplementing conventional clinical and biochemical examinations of RA patients with MRI, and intensifying treatment where bone marrow oedema is present, will help reduce disease activity, avoid progressive joint damage and prevent function loss.

The current study is therefore based on the following hypothesis:

By supplementing conventional clinical and biochemical examination of RA patients with low disease activity/in remission with MRI and intensifying treatment in the case of sub-clinical inflammation as measured by the presence of bone marrow oedema, it is possible to prevent radiographic erosive progression, improve functional level and enable more patients to achieve clinical remission.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Aarhus, Denemarken, 8600
        • Dep. of Rheumatology Aarhus Hospital
      • Copenhagen, Denemarken, 2000
        • Dep. of Rheumatology Frederiksberg Hospital
      • Copenhagen, Denemarken, 2600
        • Dep. of Rheumatology Glostrup Hospital
      • Copenhagen, Denemarken, 2900
        • Dep. of Rheumatology Gentofte Hospital
      • Graasten, Denemarken, 6300
        • Dep. of Rheumatology King Christian X´Hospital for Rheumatic Diseases
      • Hjørring, Denemarken, DK-9800
        • Department of Rheumatology University Hospital Vendsyssel
      • Odense, Denemarken, 5000
        • Dep. of rheumatology Odense Hospital
      • Silkeborg, Denemarken, 8600
        • Dep. of Rheumatology Silkeborg Hospital
      • Slagelse, Denemarken, 4200
        • Dep. of Rheumatology Slagelse Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age > 18 years
  • RA according to ACR (American College of Rheumatology)/EULAR (European League Against Rheumatism) 2010 criteria.
  • Anti-CCP positivity
  • Erosions on conventional X-ray of hands, wrists and/or feet
  • No clinically swollen joints
  • DAS28 (4 variable, CRP) < 3.2
  • DMARD monotherapy treatment OR combination treatment, in the form of 2- or 3-drug therapy. If the patient is undergoing 3-drug therapy, at least one of the preparations must be administered at less than the "maximum inclusion dose"*
  • Unchanged anti-rheumatic treatment in the previous 6 weeks or more
  • No previous treatment with biological medication
  • No contra-indications for TNF-alpha-inhibiting treatment
  • No contra-indications for MRI
  • s-creatinine within normal range
  • Ability and willingness to give written and oral informed consent and fulfil the requirements of the study programme with reference to the protocol

    • Maximum "inclusion dose" is defined as: MTX 25 mg/week (or maximum tolerated dose if 25 mg/week is not tolerated), SSZ 2g/day (or maximum tolerated dose if 2 g/day is not tolerated) and HCQ 200 mg/day (or maximum tolerated dose if 200 mg/day is not tolerated)

Exclusion Criteria:

  • Previous or current biological treatment
  • Known intolerance to methotrexate treatment which means that the patient is not able to tolerate a minimum of MTX 7.5 mg (minimum dose).
  • DMARD 3-drug therapy at maximum tolerated/maximum "inclusion dose"*
  • I.m, intra-articular or i.v glucocorticoid administration ≤ 6 weeks prior to inclusion
  • Oral glucocorticoid administration > 5 mg/day
  • Changes in oral glucocorticoid dose < 3 months prior to inclusion
  • Myocrisin treatment
  • Affected liver enzymes > 2 x the upper limit of normal at the time of screening
  • Current and/or imminent wish to become pregnant
  • Contra-indications for TNF-alpha-inhibiting treatment
  • Contra-indications for MRI
  • Known alcohol/drug abuse
  • Inability to give informed consent
  • Inability to cooperate with the study programme due to physical or mental reasons

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Conventional biochemical and clinical examinations
Biochemical and clinical examinations
Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28>3.2
Experimenteel: Conventional biochemical and clinical examinations and MRI.
Biochemical and clinical examinations and MRI.
Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28>3.2 AND/OR MRI-detected bone marrow oedema score > 0 (RAMRIS-score)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
DAS28 remission (<2.6)
Tijdsspanne: 24 month
24 month
No radiographic progression (assessed by the Sharp/vdHeijde method).
Tijdsspanne: 24 month
24 month

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
No radiographic progression (Sharp/vdHeijde score).
Tijdsspanne: 24 month
No radiographic progression (Sharp/vdHeijde score) from 0-12 and 12-24 months and change in Sharp/vdHeijde score from 0-12, 0-24 and 12-24 months.
24 month
No MRI erosion (RAMRIS) score
Tijdsspanne: 24 month
No progression in MRI erosion (RAMRIS) score from 0-12 and 12-24 months and change in MRI erosion (RAMRIS) score from 0-12, 0-24 and 12-24 months.
24 month
MRI synovitis (RAMRIS) score
Tijdsspanne: 24 months
MRI synovitis (RAMRIS) score at 12 and 24 months
24 months
MRI bone marrow oedema (RAMRIS) score
Tijdsspanne: 24 months
MRI bone marrow oedema (RAMRIS) score at 12 and 24 months
24 months
HAQ score
Tijdsspanne: 24 month
Changes in HAQ score from 0-12 and 0-24 months
24 month
SF-36 score
Tijdsspanne: 24 month
Changes in SF-36 score from 0-12 and 0-24 months
24 month
EQ-5D score
Tijdsspanne: 24 month
Changes in EQ-5D score from 0-12 and 0-24 months
24 month
ACR/EULAR 2011 remission
Tijdsspanne: 24 month
ACR/EULAR 2011 remission at 12 and 24 months
24 month
DAS28
Tijdsspanne: 24 month
DAS28 at 12 and 24 month
24 month
DAS28 remission (<2.6) at 12 months
Tijdsspanne: 24 months
24 months
biomarker analyses
Tijdsspanne: 24 month
24 month

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dynamic MRI
Tijdsspanne: 24 month
Dynamic MRI variable (including initial rate of enhancement (IRE) and maximum enhancement (ME)).
24 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Kim Hørslev-Petersen, Professor, King Christian X´Hospital for Rheumatic Diseases
  • Studie directeur: Signe Møller-Bisgaard, MD, Dep. of Rheumatology, Rigshospitalet, Glostrup
  • Studie stoel: Mikkel Østergaard, Professor, Dep. of Rheumatology, Rigshospitalet, Glostrup
  • Studie stoel: Bo Ejbjerg, MD, PhD, Dep. of Rheumatology Slagelse Hospital
  • Studie stoel: Merete Hetland, MD, PhD, DMSci, Dep. of Rheumatology, Rigshospitalet, Glostrup

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2012

Primaire voltooiing (Werkelijk)

1 mei 2017

Studie voltooiing (Werkelijk)

1 mei 2017

Studieregistratiedata

Eerst ingediend

5 juli 2012

Eerst ingediend dat voldeed aan de QC-criteria

31 juli 2012

Eerst geplaatst (Schatting)

2 augustus 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2017

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2017

Laatst geverifieerd

1 juni 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Auto-immuunziekten

3
Abonneren