Dataset Information

Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring.

ABSTRACT: The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and metacarpophalangeal joints (MCPs) were imaged using MRI. In addition to clinical assessments with DAS28(CRP), the severity of inflammation was measured as synovial leak of gadolinium based contrast agent (GBCA) using DCE-MRI (Ktrans, primary endpoint) at weeks 0, 2, 4, and 14. Two radiologists independently scored synovitis, osteitis and erosion using RA MRI Score (RAMRIS) and cartilage loss using a 9-point MRI scale (CARLOS). Infliximab showed greater decrease from baseline in DAS28(CRP), DCE-MRI Ktrans of wrist and MCP synovium, and RAMRIS synovitis and osteitis at all visits compared with placebo (p<0.001). Treatment effect sizes of infliximab therapy were similar for DAS28(CRP) (1.08; 90% CI (0.63-1.53)) and MRI inflammation endpoints: wrist Ktrans (1.00 (0.55-1.45)), RAMRIS synovitis (0.85 (0.38-1.28)) and RAMRIS osteitis (0.99 (0.52-1.43)). Damage measures of bone erosion (RAMRIS) and cartilage loss (CARLOS) were reduced with infliximab compared to with placebo at 14 weeks (p?0.025). DCE-MRI and RAMRIS were equally sensitive and responsive to the anti-inflammatory effects of infliximab. RAMRIS and CARLOS showed suppression of erosion and cartilage loss, respectively, at 14 weeks. (ClinicalTrials.gov registration: NCT01313520).

SUBMITTER: Beals C

PROVIDER: S-EPMC5728526 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring.

Beals Chan C Baumgartner Richard R Peterfy Charles C Balanescu Andra A Mirea Gavrila G Harabagiu Alexandru A Popa Serghei S Cheng Amy A Feng Dai D Ashton Edward E DiCarlo Julie J Vallee Marie-Helene MH Dardzinski Bernard J BJ

PloS one 20171213 12

The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and ...[more]

PMID: 29236711

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Project description:Treatment of severely destroyed rheumatoid wrists with total wrist arthroplasty or total wrist arthrodesis relies on patient and surgeon preferences rather than rigorous prospective outcomes data. The purpose of this study is to develop a decision analytic model of arthroplasty and arthrodesis in rheumatoid arthritis (RA) using utility values obtained from a random sample of hand surgeons.A utility survey using a time trade-off design was administered to 175 members of the American Society for Surgery of the Hand. Based on the results of the survey, the utility values that surgeons assign to health states associated with arthroplasty and arthrodesis and their complications were calculated. By combining utility values with complication rates in the published literature, we developed a decision tree to calculate the expected quality-adjusted life years (QALYs) for each procedure compared to living with a painful RA wrist.Based on surgeon preferences, living for 30 years with a painful, poorly functioning RA wrist (utility = 0.54) is associated with 16.2 QALYs. Treatment with arthroplasty (utility = 0.85) is associated with 25.5 QALYs, a gain of 9.3 QALYs over nonsurgical management. Arthrodesis (utility = 0.82) is associated with 24.6 QALYs, a gain of 8.4 QALYs over nonsurgical management. Arthroplasty is associated with a small incremental increase in QALYs (0.9) compared to arthrodesis.Based on utility scores, hand surgeons feel that living with a painful, poorly functioning RA wrist for 30 years is worth approximately half as many years with a painless, well-functioning wrist. The outcomes for arthroplasty and arthrodesis are valued more than nonsurgical management. On the basis of its higher expected gain in QALYs, arthroplasty should be the preferred treatment. The minimal increase in utility for arthroplasty over arthrodesis suggests however, that surgeons do not view arthroplasty as superior to arthrodesis.Economic and decision analysis IV.

Project description:BACKGROUND: Folklore remedies for pain and inflammation in rheumatoid arthritis include the application of magnets and copper to the skin. Despite the popular use of devices containing magnets or copper for this purpose, little research has been conducted to evaluate the efficacy of such treatments. OBJECTIVE: To investigate whether the practice of wearing magnetic wrists straps, or copper bracelets, offers any specific therapeutic benefit for patients with rheumatoid arthritis. DESIGN: Randomised double-blind placebo-controlled crossover trial. METHODS: 70 patients, aged 33 to 79 years and predominantly female (n = 52), with painful rheumatoid arthritis were recruited from general practices within Yorkshire. Participants were randomly allocated to wear four devices in a different order. Devices tested were: a standard (1502 to 2365 gauss) magnetic wrist strap, a demagnetised (<20 gauss) wrist strap, an attenuated (250 to 350 gauss) magnetic wrist strap, and a copper bracelet. Devices were each worn for five weeks, with treatment phases being separated by one week wash-out periods. The primary outcome measured was pain using a 100 mm visual analogue scale. Secondary pain measures were the McGill Pain Questionnaire and tender joint count. Inflammation was assessed using C-reactive protein and plasma viscosity blood tests and by swollen joint count. Physical function was assessed using the Health Assessment Questionnaire (Disability Index). Disease activity and medication use was also measured. RESULTS: 65 participants provided complete self-report outcome data for all devices, four participants provided partial data. Analysis of treatment outcomes did not reveal any statistically significant differences (P>0.05) between the four devices in terms of their effects on pain, inflammation, physical function, disease activity, or medication use. CONCLUSIONS: Wearing a magnetic wrist strap or a copper bracelet did not appear to have any meaningful therapeutic effect, beyond that of a placebo, for alleviating symptoms and combating disease activity in rheumatoid arthritis. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN51459023 ISRCTN51459023.

Dataset Information

Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring.

Publications

Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring.

Similar Datasets

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