Literature DB >> 15037445

Radiography as primary outcome in rheumatoid arthritis: acceptable sample sizes for trials with 3 months' follow up.

K Bruynesteyn1, R Landewé, Sj van der Linden, D van der Heijde.   

Abstract

OBJECTIVES: To investigate whether plain radiographs can show changes in joint damage due to rheumatoid arthritis (RA) within 3 months.
METHODS: 188 film pairs taken with a 3 month interval were evaluated. They were scored with (chronological) and without (paired) knowledge of the sequence of the films according to the Sharp/van der Heijde method. Changes in joint damage were analysed on a group and an individual level for different subsets of patients. Sample sizes required to detect statistically and clinically significant differences were estimated based on the percentages of patients with progression larger than the smallest detectable change (SDC).
RESULTS: Changes in joint damage were seen by both the chronological and the paired scoring method. The percentage of patients with progression of joint damage larger than the corresponding SDCs (1.7 and 2.4) varied in the subsets from 18% to 64% if based on the chronological change-scores and from 9% to 36% using paired change-scores. Acceptable sample size estimates were seen in several subsets, depending on (a) how the investigated drug would reduce the individual risk of progression of joint damage (by an absolute or a relative risk reduction model); (b) how damage was scored (chronological or paired); (c) the baseline risk; and (d) whether a two sided or one sided test would be used.
CONCLUSIONS: Changes in joint damage due to RA can be detected reliably already within 3 months. This finding can be used to plan short term, randomised controlled trials with radiographic progression as primary outcome.

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Year:  2004        PMID: 15037445      PMCID: PMC1754812          DOI: 10.1136/ard.2003.014043

Source DB:  PubMed          Journal:  Ann Rheum Dis        ISSN: 0003-4967            Impact factor:   19.103


  18 in total

1.  Reading radiographs in chronological order, in pairs or as single films has important implications for the discriminative power of rheumatoid arthritis clinical trials.

Authors:  D van Der Heijde; A Boonen; M Boers; P Kostense; S van Der Linden
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2.  How to read radiographs according to the Sharp/van der Heijde method.

Authors:  D van der Heijde
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3.  How to report radiographic data in randomized clinical trials in rheumatoid arthritis: guidelines from a roundtable discussion.

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4.  The ethics of sample size: two-sided testing and one-sided thinking.

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Journal:  N Engl J Med       Date:  2000-11-30       Impact factor: 91.245

7.  Inflammation and damage in an individual joint predict further damage in that joint in patients with early rheumatoid arthritis.

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9.  Clinical trials in rheumatoid arthritis: methodological suggestions for assessing radiographs arising from the GRISAR Study. Gruppo Reumatologi Italiani Studio Artrite Reumatoide.

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10.  Treatment with leflunomide slows radiographic progression of rheumatoid arthritis: results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group.

Authors:  J T Sharp; V Strand; H Leung; F Hurley; I Loew-Friedrich
Journal:  Arthritis Rheum       Date:  2000-03
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Journal:  Ann Rheum Dis       Date:  2006-01-05       Impact factor: 19.103

Review 2.  Presentation and analysis of radiographic data in clinical trials and observational studies.

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6.  Validity of early MRI structural damage end points and potential impact on clinical trial design in rheumatoid arthritis.

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7.  Treating rheumatoid arthritis to target: recommendations of an international task force.

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Journal:  Ann Rheum Dis       Date:  2010-03-09       Impact factor: 19.103

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9.  MMP-3 as a predictor for structural remission in RA patients treated with MTX monotherapy.

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10.  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.

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