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1
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Each trial should report the disease activity response and disease activity states
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1a
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Response: ACR (ACR20, ACR50, ACR70: ideally also ACR Hybrid, after successful prospective validation in clinical trials) and EULAR response criteria (good, moderate and non-responders)
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1b
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States: composite measures of disease activity should be used as outcome measures and with cut-off points to define various disease activity states: they include DAS/DAS28, CDAI, and SDAI; appropriate descriptive statistics of the baseline, the endpoint and change of the composite indices should be reported
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2
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Each trial should report the appropriate descriptive statistics of the baseline, the endpoint, and change of the single variables included in the core set
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3
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Each trial should report the baseline disease activity levels
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4
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Each trial should report the percentage of patients achieving a low disease activity state and remission
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4a
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Definitions that should be used for low disease activity include cut-off points for low disease activity for DAS/DAS28, CDAI, SDAI, and MDA
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4b
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Definitions that could be used for remission include preliminary ARA remission criteria and respective cut-off points for DAS/DAS28, CDAI, and SDAI
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5
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Each trial should report the time to onset of the primary outcome (a particular response or a certain disease activity state)
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6
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Each trial should consider and report the sustainability of the primary outcome (as opposed to evaluating it at a single predefined time point during the trial)
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7
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Each trial should report on fatigue
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