Overview

This trial is active, not recruiting.

Condition inflammatory arthritis
Treatments mri, radiography, standard of care
Phase phase 4
Sponsor McMaster University
Start date June 2009
End date October 2012
Trial size 186 participants
Trial identifier NCT00808496, 200901

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose diagnostic
Arm
(Experimental)
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.
mri Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
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.
(Active Comparator)
Biannual disease progression monitoring with radiography of both hands and wrists.
radiography Diagnostic Imaging: Conventional 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.
(Placebo Comparator)
Diagnostic imaging results (MRI or radiography) reported to upon requisition.
standard of care Placebo control: see MRI and radiography interventions.
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

Primary Outcomes

Measure
The frequency of antirheumatic treatment escalations.
time frame: Two years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Ruben Tavares, MBt MSc CCRA
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by McMaster University.