Sa1217 Once Daily Dosing of 9mg Budesonide (Budenofalk®) Is Therapeutic Equivalent to a Three-Times Daily Dosing of 3mg Budesonide for the Treatment of Active Crohn's Disease: A Randomized, Double-Blind, Double-Dummy, Multicenter Phase III Study

2013 ◽  
Vol 144 (5) ◽  
pp. S-233 ◽  
Author(s):  
Axel U. Dignass ◽  
Simeon Stoynov ◽  
Andrey E. Dorofeyev ◽  
Galina A. Grigorieva ◽  
Eva Tomsova ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Phase Iii ◽  
Double Blind ◽  
Once Daily ◽  
Multicenter Phase ◽  
Phase Iii Study

scholarly journals Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study

Pituitary ◽  
2014 ◽  
Vol 18 (3) ◽  
pp. 385-394 ◽  
Author(s):  
Michael Sheppard ◽  
Marcello D. Bronstein ◽  
Pamela Freda ◽  
Omar Serri ◽  
Laura De Marinis ◽  
...  
Keyword(s):  
Phase Iii ◽  
Extension Phase ◽  
Double Blind ◽  
Multicenter Phase ◽  
Phase Iii Study

scholarly journals Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn’s disease: results from a randomized trial

2020 ◽  
Vol 13 ◽  
pp. 175628482093896
Author(s):  
Baili Chen ◽  
Xiang Gao ◽  
Jie Zhong ◽  
Jianlin Ren ◽  
Xuan Zhu ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Activity Index ◽  
High Sensitivity ◽  
Phase Iii ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind

Background and Aims: Efficacy of adalimumab in Crohn’s disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD. Methods: This 26-week, multicenter, phase III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (⩾3 mg/l) who were naïve to anti–tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80 mg at weeks 0/2 and 40 mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80 mg at weeks 4/6. At week 8, all patients received open-label 40 mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ⩾70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study. Results: At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo ( p < 0.001) achieved clinical remission. Among week-8 responders, 93/144 (65%) achieved clinical remission at week 26 ( p < 0.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported. Conclusions: Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab. identifier: NCT02499783

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