The Effect of Biannual Monitoring With Magnetic Resonance Imaging (MRI), X-ray, or Usual Care on Treatment for Inflammatory Arthritis (MRx)
|ClinicalTrials.gov Identifier: NCT00808496|
Recruitment Status : Unknown
Verified October 2011 by Ruben Tavares, McMaster University.
Recruitment status was: Active, not recruiting
First Posted : December 15, 2008
Last Update Posted : October 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Arthritis||Other: MRI Other: Radiography Other: Standard of Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Randomized Controlled Trial to Compare Biannual Peripheral Magnetic Resonance Imaging, Radiography, and Standard of Care on Pharmacotherapeutic Escalation in Inflammatory Arthritis|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||April 2013|
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.
Other Name: Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
Active Comparator: 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.
Other Name: 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 Name: Placebo control: see MRI and radiography interventions.
- The frequency of antirheumatic treatment escalations. [ Time Frame: Two years ]
- Change in van der Heijde-modified Sharp score of the hands and feet. [ Time Frame: Two years ]
- Change in 28-joint disease activity score (DAS28) [ Time Frame: Two years ]
- Change in health assessment questionnaire (HAQ) score [ Time Frame: Two years ]
- Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS) [ Time Frame: Two years ]
- Change in health utility index - mark 3 (HUI-III) [ Time Frame: Two years ]
- Change in EQ-5D [ Time Frame: Two years ]
- Number of smallest detectable changes [ Time Frame: Two years ]
- Change in the proportion of participants with radiography-determined erosions of the hands, wrists, or feet [ Time Frame: Two years ]
- Change in the number of radiography-determined erosions of the hands, wrists or feet [ Time Frame: Two years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808496
|McMaster University, Division of Rheumatology|
|Hamilton, Ontario, Canada, L8N 1Y2|
|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|