The majority of patients had a history of synthetic DMARD or combination of synthetic and biologic DMARD therapy, with low-to-moderate disease activity, except RAPID-3 scores that showed high disease activity in the only one medical center (interestingly, CDAI
scores also recorded for this patient population in this particular medical center corresponded to a low-to-moderate disease activity as in the other medical centers; data on file).
16.7%) in terms of the percentage of CDAI-100 improvement ([greater than or equal to]100-point decrease in the CDAI
score), which was a primary endpoint of the induction period, however the difference was not statistically significant [p = 0.1448; adjusted odds ratio (AOR) = 1.80; 95% CI, 0.816-3.958].
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.
is based on the simple sum of the swollen/tender joint counts-28 joints, along with patient and physician global assessment (PaGA and PhGA, respectively) of disease activity (on a 0-10 VAS scale) .
The 94 patients with PsA in the Corrona registry study all met study criteria for remission or LDA (CDAI
score of 10 or less) and had discontinued their TNFi while in LDA and did not immediately switch to a different biologic.
(ii) The recommendation framework of the CDAI
method is proposed (see Section 5).
Parameters tested were disease duration, gender, baseline mean ESR and CRP serum levels, mean lipid levels and fractions, baseline mean DAS28, mean CDAI
, and mean HAQ.
Various tools like disease activity score in 28 joints (DAS-28), simplified and clinical disease activity indices (SDAI, CDAI
) are in common use to monitor treatment efficacy4.
As the Crohn's Disease Activity Index (CDAI
) was <150, indicating non-active disease, no medical treatment was provided.
DA was calculated using 'Clinical Disease Activity Index' (CDAI
) score at base line and after 6 months of DMARDs therapy.
The second control group consisted of 40 women with active IBD (mean: 39.6 years, SD: 15 years) and 23 women with IBD in sustained clinical remission (mean: 42.0 years, SD: 13.9 years) (Table 1).The clinical activity of IBD was assessed with partial Mayo (pMayo) (4,5) score in ulcerative colitis (UC) patients and with Crohn's Disease Activity Index (CDAI
) in Crohn's disease (CD) patients.
The primary objective of this first study is to compare filgotinib to placebo in establishing clinical remission, which is defined as CDAI