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Many studies in UC or in CD used different disease progression index scores for definition of their model health states, including CDAI, HBI, or UCDAI scores.
Disease activity for UC was assessed using the UC disease activity index (UCDAI); patients scoring UCDAI 4-12, alongside diagnosis from clinical parameters, radiographic studies, endoscopic and histological criteria, were defined as active UC.
When the two invasive indices were compared with each other, the UCDAI endoscopy item predicted only 0.04% of the variance in the St.
In the UCDAI, a reduction of 50% was achieved at 6 weeks.
In these studies, UCERIS 9 mg administered once daily achieved the primary endpoint of superiority to placebo (p=0.0143 in US trial and p=0.0047 in EU trial) in attaining clinical remission in the intent-to-treat (ITT) population as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of therapy.
The primary endpoint is the achievement of clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment, added the company.
The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment.
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