Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

6 octobre 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

186

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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. 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.

Autres noms:
  • Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
Comparateur actif: Radiography
Biannual disease progression monitoring with radiography of both hands and wrists.
Autre: Radiography

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.

Autres noms:
  • Diagnostic Imaging: Conventional radiography.
Comparateur placebo: Standard of Care
Diagnostic imaging results (MRI or radiography) reported to upon requisition.
Autre: Standard of Care
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
Autres noms:
  • Placebo control: see MRI and radiography interventions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
The frequency of antirheumatic treatment escalations.
Délai: Two years
Two years

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

McMaster University

Les enquêteurs

  • Chercheur principal: Ruben Tavares, MBt MSc CCRA, McMaster University
  • Chaise d'étude: Jonathan D Adachi, MD FRCPC, McMaster University
  • Directeur d'études: Maggie J Larche, MD PhD, McMaster University
  • Directeur d'études: Colin E Webber, PhD CCPM, McMaster University
  • Directeur d'études: Naveen Parasu, MD FRCPC, McMaster University
  • Directeur d'études: Karen A Beattie, PhD, McMaster University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2009

Achèvement primaire (Anticipé)

1 octobre 2012

Achèvement de l'étude (Anticipé)

1 avril 2013

Dates d'inscription aux études

Première soumission

12 décembre 2008

Première soumission répondant aux critères de contrôle qualité

12 décembre 2008

Première publication (Estimation)

15 décembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

7 octobre 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 octobre 2011

Dernière vérification

1 octobre 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 200901

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur MRI

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Malta

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner