Patient selection: diffuse cutaneous systemic sclerosis in clinical trial
CRISS involves 2 steps:
(1) an initial assessment for disease progression
(2) an estimate of the probability for improvmenet
If the patient develops new or worsening cardiac, pulmonary and/or renal involvement during the clinical trial then the person is assigned a probability of improvement of 0. This is irrespective of changes in other core items.
Conditions associated with non-improvement – one or more of the following:
(1) new scleroderma renal crisis
(2) new onset of systemic sclerosis-related lung disease with
(2a) decline in predicted FVC >= 15% (confirmed by repeat testing within one month)
(2b) high resolution chest CT to confirm interstitial lung disease (ILD)
(2c) FVC less than 80% of predicted
(3) new onset of left ventricular failure (LVEF <= 45%) and requiring treatment
(4) new onset of pulmonary arterial hypertension (PAH) requiring treatment (with right heart catheterization)
If the patient does not show any of these findings, then the probability of improvement can be estimated in the second step.
