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

NCT00808496 | Unknown Phase 4 DMC

• 1 other identifier: 200901
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Arthritis

Keywords

Magnetic resonance imaging; Radiography; Randomized controlled trial; Antirheumatic agents

Outcome Measures

Primary Outcomes (1)

• The frequency of antirheumatic treatment escalations.

  Two years

Secondary Outcomes (9)

• Change in van der Heijde-modified Sharp score of the hands and feet.

  Two years

• Change in 28-joint disease activity score (DAS28)

  Two years

• Change in health assessment questionnaire (HAQ) score

  Two years

• Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS)

  Two years

• Change in health utility index - mark 3 (HUI-III)

  Two years

Study Arms (3)

MRI

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.

Other: MRI

Radiography

ACTIVE COMPARATOR

Biannual disease progression monitoring with radiography of both hands and wrists.

Other: Radiography

Standard of Care

PLACEBO COMPARATOR

Diagnostic imaging results (MRI or radiography) reported to upon requisition.

Other: Standard of Care

Interventions

MRI OTHER

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.

Also known as: Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)

MRI

Radiography OTHER

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.

Also known as: Diagnostic Imaging: Conventional radiography.

Radiography

Standard of Care OTHER

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

Also known as: Placebo control: see MRI and radiography interventions.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University, Division of Rheumatology

Hamilton, Ontario, L8N 1Y2, Canada

Location

Related Publications (10)

• 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. doi: 10.1002/art.23945.

  PMID: 18821687 BACKGROUND

• 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. doi: 10.1185/030079907x178892.

  PMID: 17519063 BACKGROUND

• 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. doi: 10.1136/ard.58.3.156.

  PMID: 10364913 BACKGROUND

• 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.

  PMID: 18322995 BACKGROUND

• 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.

  PMID: 19032820 BACKGROUND

• 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. doi: 10.1016/s0140-6736(89)92442-2.

  PMID: 2565997 BACKGROUND

• Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.

  PMID: 4597226 BACKGROUND

• 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. doi: 10.1002/art.23721. No abstract available.

  PMID: 18512708 BACKGROUND

• 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. doi: 10.1136/ard.61.4.290.

  PMID: 11874828 BACKGROUND

• Tavares R, Beattie KA, Bensen WG, Bobba RS, Cividino AA, Finlay K, Goeree R, Hart LE, Jurriaans E, Larche MJ, Parasu N, Tarride JE, Webber CE, Adachi JD. A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial. Trials. 2014 Jul 5;15:268. doi: 10.1186/1745-6215-15-268.

  PMID: 24997587 DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

X-Rays; Standard of Care

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ruben Tavares, MBt MSc CCRA

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jonathan D Adachi, MD FRCPC

  McMaster University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: June 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: October 7, 2011

Record last verified: 2011-10

Locations

CA (1)