Table 5 EULAR/ACR collaborative recommendations for disease activity reporting in clinical trials

1

Each trial should report the disease activity response and disease activity states

1a

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)

1b

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

2

Each trial should report the appropriate descriptive statistics of the baseline, the endpoint, and change of the single variables included in the core set

3

Each trial should report the baseline disease activity levels

4

Each trial should report the percentage of patients achieving a low disease activity state and remission

4a

Definitions that should be used for low disease activity include cut-off points for low disease activity for DAS/DAS28, CDAI, SDAI, and MDA

4b

Definitions that could be used for remission include preliminary ARA remission criteria and respective cut-off points for DAS/DAS28, CDAI, and SDAI

5

Each trial should report the time to onset of the primary outcome (a particular response or a certain disease activity state)

6

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)

7

Each trial should report on fatigue