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The Effect of Biannual Monitoring With Magnetic Resonance Imaging (MRI), X-ray, or Usual Care on Treatment for Inflammatory Arthritis (MRx)

6. oktober 2011 oppdatert av: Ruben Tavares, McMaster University

A Double Blind Randomized Controlled Trial to Compare Biannual Peripheral Magnetic Resonance Imaging, Radiography, and Standard of Care on Pharmacotherapeutic Escalation in Inflammatory Arthritis

Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes functional disability and physical deformity. Many inflammatory arthritis patients develop permanent joint damage within the first two years of disease. Early, aggressive treatment with drugs called disease-modifying antirheumatic drugs (DMARDs) is known to reduce how quickly this damage occurs. Sometimes, however, even when patients' symptoms are under control, the disease continues to cause joint damage.

This study will determine if magnetic resonance imaging (also known as 'MRI') conducted every six months provides arthritis specialists with information to help them better treat peripheral inflammatory arthritis patients over the first two years of care. The effect of MRI will be compared to 1) the use of x-ray every six months; and, 2) the frequency at which these tests are usually used. The study will also determine if differences in treatment between the three groups result in differences in the well-being of patients.

A total of 186 patients with early signs of inflammatory arthritis will be studied. All participants will have an MRI and x-ray conducted every six months. One-third of participants (62 in total) will only have MRI information sent to their arthritis specialist (MRI group); 62 will have x-ray information sent (X-ray group); and, the remaining 62 will have x-ray information sent only when ordered by the arthritis specialist (Usual Care group). Negative disease progression reports will be sent to the arthritis specialist unless intervention allocation-specific disease progression is detected. In which case, a report blinded to imaging modality will be sent indicating the detection of disease progression relative to the last timepoint of progression, or baseline, as applicable. At any point in the study, the arthritis specialist can request a clinical MRI or x-ray for any participant.

Neither the participants nor their doctors will know to which group they are assigned. A computer program will randomly assign participants to one of the three groups using a technique called minimization. This technique accounts for differences between participants that are known to effect disease progression and treatment decisions. Using this technique, participants with similar disease will be evenly distributed between the three groups.

The results of this study will have a direct impact on care for new inflammatory arthritis patients. It will determine the benefits, if any, of regular monitoring of disease progression with MRI or x-ray. Using tests proven to help treatment decision-making, arthritis specialists will improve the care provided to new inflammatory arthritis patients.

Studieoversikt

Detaljert beskrivelse

The proposed project is a double-blinded randomized-controlled trial to determine if biannual monitoring of inflammatory arthritis disease progression with 1.0T peripheral magnetic resonance imaging (pMRI) of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline compared to conventional radiography of both hands and wrists, or standard of care, alters the frequency of pharmacological treatment escalation at two years. A sample size of 186 (62 per group) is required to determine mean differences in the rate of pharmacological treatment escalation between the three groups with 90% power at a 5% level of significance, assuming a 5% spontaneous remission rate, 15% missing data, and 5% annual attrition.

Studietype

Intervensjonell

Registrering (Forventet)

186

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • McMaster University, Division of Rheumatology

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • At least 18 years of age at study enrollment.
  • At least three swollen joints; OR,
  • Metacarpophalangeal joint(s) positive squeeze test; OR,
  • Metatarsophalangeal joint(s) positive squeeze test; OR,
  • At least 30 minutes of self-reported morning stiffness.
  • At least six weeks of self-reported symptom duration.

Exclusion Criteria:

  • Self-reported symptom onset prior to 17 years of age.
  • Medical history of juvenile arthritis
  • Evidence of viral arthritis
  • A concomitant condition with medical priority over inflammatory arthritis, or that contraindicates treatment with DMARDs excluding sulfa allergy or medically controlled, non-terminal liver disease.
  • Refusal to receive DMARD treatment
  • Patients with a psychological deficit, or diminished capacity to provide independent, informed consent
  • Any contraindication to MRI or x-ray
  • Current or planned pregnancy
  • Lactation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MRI
Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline.

Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. Scored using the Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS).

MRI intervention group also undergoes radiography imaging. Only protocol determined smallest detectable changes on MRI reported.

Andre navn:
  • Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
Aktiv komparator: Radiography
Biannual disease progression monitoring with radiography of both hands and wrists.

Biannual disease progression monitoring with radiography of both hands and wrists. Scored using the van der Heijde-modified Sharp score.

Radiography intervention group also undergoes MRI imaging. Only protocol determined smallest detectable changes on radiography reported.

Andre navn:
  • Diagnostic Imaging: Conventional radiography.
Placebo komparator: Standard of Care
Diagnostic imaging results (MRI or radiography) reported to upon requisition.
Diagnostic imaging results (MRI or radiography) reported upon requisition. Standard of Care intervention group undergoes both MRI and radiography imaging. Upon requisition of either MRI or radiography, radiology reports are delivered as per institutional standard of care
Andre navn:
  • Placebo control: see MRI and radiography interventions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The frequency of antirheumatic treatment escalations.
Tidsramme: Two years
Two years

Sekundære resultatmål

Resultatmål
Tidsramme
Change in van der Heijde-modified Sharp score of the hands and feet.
Tidsramme: Two years
Two years
Change in 28-joint disease activity score (DAS28)
Tidsramme: Two years
Two years
Change in health assessment questionnaire (HAQ) score
Tidsramme: Two years
Two years
Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS)
Tidsramme: Two years
Two years
Change in health utility index - mark 3 (HUI-III)
Tidsramme: Two years
Two years
Change in EQ-5D
Tidsramme: Two years
Two years
Number of smallest detectable changes
Tidsramme: Two years
Two years
Change in the proportion of participants with radiography-determined erosions of the hands, wrists, or feet
Tidsramme: Two years
Two years
Change in the number of radiography-determined erosions of the hands, wrists or feet
Tidsramme: Two years
Two years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ruben Tavares, MBt MSc CCRA, McMaster University
  • Studiestol: Jonathan D Adachi, MD FRCPC, McMaster University
  • Studieleder: Maggie J Larche, MD PhD, McMaster University
  • Studieleder: Colin E Webber, PhD CCPM, McMaster University
  • Studieleder: Naveen Parasu, MD FRCPC, McMaster University
  • Studieleder: Karen A Beattie, PhD, McMaster University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2009

Primær fullføring (Forventet)

1. oktober 2012

Studiet fullført (Forventet)

1. april 2013

Datoer for studieregistrering

Først innsendt

12. desember 2008

Først innsendt som oppfylte QC-kriteriene

12. desember 2008

Først lagt ut (Anslag)

15. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. oktober 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. oktober 2011

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

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