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

22. juni 2017 opdateret af: Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional biochemical and clinical examinations
Biochemical and clinical examinations
Andet: Conventional 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
Eksperimentel: Conventional biochemical and clinical examinations and MRI.
Biochemical and clinical examinations and MRI.
Procedure: Magnetic resonance imaging (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)

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamic MRI
Tidsramme: 24 month
Dynamic MRI variable (including initial rate of enhancement (IRE) and maximum enhancement (ME)).
24 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen

Samarbejdspartnere

Abbott
Glostrup University Hospital, Copenhagen
Slagelse Hospital
King Christian X´Hospital for Rheumatic Diseases

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. marts 2012

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. maj 2017

Datoer for studieregistrering

Først indsendt

5. juli 2012

Først indsendt, der opfyldte QC-kriterier

31. juli 2012

Først opslået (Skøn)

2. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMAGINE-RA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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