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

October 6, 2011 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

Other Names:
  • Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
Active Comparator: Radiography
Biannual disease progression monitoring with radiography of both hands and wrists.
Other: 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.

Other Names:
  • Diagnostic Imaging: Conventional radiography.
Placebo Comparator: Standard of Care
Diagnostic imaging results (MRI or radiography) reported to upon requisition.
Other: 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
Other Names:
  • Placebo control: see MRI and radiography interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency of antirheumatic treatment escalations.
Time Frame: Two years
Two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Ruben Tavares, MBt MSc CCRA, McMaster University
  • Study Chair: Jonathan D Adachi, MD FRCPC, McMaster University
  • Study Director: Maggie J Larche, MD PhD, McMaster University
  • Study Director: Colin E Webber, PhD CCPM, McMaster University
  • Study Director: Naveen Parasu, MD FRCPC, McMaster University
  • Study Director: Karen A Beattie, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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