Table 1 Recommendations*
PointDescription
1Each trial should report the disease activity response and disease activity states
1aResponse: ACR (ACR20, ACR50, ACR70; ideally also ACR Hybrid, after successful prospective validation in clinical trials) and EULAR response criteria (good, moderate and non-responders)
1bStates: composite indices of disease activity should be used as continuous measures and with cut-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
2Each trial should report the appropriate descriptive statistics of the baseline, the endpoint and change of the single variables included in the core set
3Each trial should report the baseline disease activity levels, which could have relevance when interpreting the results
4Each trial should report the percentage of patients achieving a low disease activity state and remission
4aDefinitions that should be used for low disease activity include cut-points for low disease activity for DAS/DAS28, CDAI, SDAI and MDA
4bDefinitions that could be used for remission include preliminary ARA remission criteria and respective cut-points for DAS/DAS28, CDAI and SDAI
5Each trial should report the time to onset of the primary outcome (a particular response or a certain disease activity state)
6Each 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)
7Each trial should report on fatigue
  • *There are several domains that are important in reporting clinical trials: disease activity, function and damage. For each of these domains response and state should be assessed and reported in clinical trials, where appropriate. However, the points in the table deal specifically with disease activity.

  • ACR, American College of Rheumatology; ACR2050/70/Hybrid, 20%/50%/70%/hybrid of measures improvement as per ACR criteria; ARA, American Rheumatism Association; CDAI, Clinical Disease Activity Index; DAS(28), (28-joint) Disease Activity Score; EULAR, European League Against Rheumatism; MDA, Minimal Disease Activity; SDAI, Simplified Disease Activity Index.