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

Sponsor:	McMaster University
Information provided by (Responsible Party):	Ruben Tavares, McMaster University
ClinicalTrials.gov Identifier:	NCT00808496

Purpose

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	Intervention	Phase
Inflammatory Arthritis	Other: MRI Other: Radiography Other: Standard of Care	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

The frequency of antirheumatic treatment escalations. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in van der Heijde-modified Sharp score of the hands and feet. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in 28-joint disease activity score (DAS28) [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in health assessment questionnaire (HAQ) score [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in health utility index - mark 3 (HUI-III) [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in EQ-5D [ Time Frame: Two years ] [ Designated as safety issue: No ]
Number of smallest detectable changes [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in the proportion of participants with radiography-determined erosions of the hands, wrists, or feet [ Time Frame: Two years ] [ Designated as safety issue: No ]
Change in the number of radiography-determined erosions of the hands, wrists or feet [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	186
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808496

Locations

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

Sponsors and Collaborators

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

More Information

Additional Information:

Centre for Appendicular MRI Studies This link exits the ClinicalTrials.gov site

Publications:

Brown AK, Conaghan PG, Karim Z, Quinn MA, Ikeda K, Peterfy CG, Hensor E, Wakefield RJ, O'Connor PJ, Emery P. An explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum. 2008 Oct;58(10):2958-67.

Schiff MH, Hobbs KF, Gensler T, Keenan GF. A retrospective analysis of low-field strength magnetic resonance imaging and the management of patients with rheumatoid arthritis. Curr Med Res Opin. 2007 May;23(5):961-8.

McQueen FM, Stewart N, Crabbe J, Robinson E, Yeoman S, Tan PL, McLean L. Magnetic resonance imaging of the wrist in early rheumatoid arthritis reveals progression of erosions despite clinical improvement. Ann Rheum Dis. 1999 Mar;58(3):156-63.

Olech E, Freeston JE, Conaghan PG, Hensor EM, Emery P, Yocum D. Using extremity magnetic resonance imaging to assess and monitor early rheumatoid arthritis: the optimal joint combination to be scanned in clinical practice. J Rheumatol. 2008 Apr;35(4):580-3. Epub 2008 Mar 1.

Xie X, Webber CE, Adachi JD, O'Neill J, Inglis D, Bobba RS, Wu H. Quantitative, small bore, 1 Tesla, magnetic resonance imaging of the hands of patients with rheumatoid arthritis. Clin Exp Rheumatol. 2008 Sep-Oct;26(5):860-5.

van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, vad de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet. 1989 May 13;1(8646):1036-8.

Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. No abstract available.

Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, Paulus HE, Mudano A, Pisu M, Elkins-Melton M, Outman R, Allison JJ, Suarez Almazor M, Bridges SL Jr, Chatham WW, Hochberg M, MacLean C, Mikuls T, Moreland LW, O'Dell J, Turkiewicz AM, Furst DE; American College of Rheumatology. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008 Jun 15;59(6):762-84. No abstract available.

Emery P, Breedveld FC, Dougados M, Kalden JR, Schiff MH, Smolen JS. Early referral recommendation for newly diagnosed rheumatoid arthritis: evidence based development of a clinical guide. Ann Rheum Dis. 2002 Apr;61(4):290-7. Review.

Responsible Party:	Ruben Tavares, PhD Candidate, McMaster University
ClinicalTrials.gov Identifier:	NCT00808496 History of Changes
Other Study ID Numbers:	200901
Study First Received:	December 12, 2008
Last Updated:	October 6, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

Magnetic resonance imaging
Radiography
Randomized controlled trial
Antirheumatic agents

Additional relevant MeSH terms:

Arthritis
Joint Diseases
Musculoskeletal Diseases

Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012