. "1"^^ . "N" . "Praha" . . "1"^^ . "3"^^ . . "Multicentrick\u00E9, randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, placebem kontrolovan\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 s paraleln\u00EDmi skupinami posuzuj\u00EDc\u00ED \u00FA\u010Dinnost a bezpe\u010Dnost apremilastu (CC-10004) v l\u00E9\u010Db\u011B aktivn\u00ED ankylozuj\u00EDc\u00ED spondylitidy"@cs . . . "ankylosing spondylitis"@en . "A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis"@en . . "Phillip, Tom" . . "[E78E1AA83BA2]" . . "RIV/00064190:_____/13:#0000730" . "Multicentrick\u00E9, randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, placebem kontrolovan\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 s paraleln\u00EDmi skupinami posuzuj\u00EDc\u00ED \u00FA\u010Dinnost a bezpe\u010Dnost apremilastu (CC-10004) v l\u00E9\u010Db\u011B aktivn\u00ED ankylozuj\u00EDc\u00ED spondylitidy" . . . "Multicentrick\u00E9, randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, placebem kontrolovan\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 s paraleln\u00EDmi skupinami posuzuj\u00EDc\u00ED \u00FA\u010Dinnost a bezpe\u010Dnost apremilastu (CC-10004) v l\u00E9\u010Db\u011B aktivn\u00ED ankylozuj\u00EDc\u00ED spondylitidy" . "Vyhodnocen\u00ED \u00FA\u010Dinnosti apremilast 30 mg dvakr\u00E1t denn\u011B (BID), ve srovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F u pacient\u016F s aktivn\u00ED AS u 16 t\u00FDdnech l\u00E9\u010Dby Sekund\u00E1rn\u00ED c\u00EDle studie - zhodnotit \u00FA\u010Dinnost apremilast 30 mg dvakr\u00E1t denn\u011B, v porovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F, zlep\u0161en\u00ED fyzick\u00E9 funkce a rozsah pohybu u pacient\u016F s aktivn\u00ED AS po 24 t\u00FDdnech l\u00E9\u010Dby. - zhodnotit \u00FA\u010Dinnost apremilast 20 mg dvakr\u00E1t denn\u011B, ve srovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F, zlep\u0161en\u00ED fyzick\u00E9 funkce a rozsah pohybu u pacient\u016F s aktivn\u00ED AS po 24 t\u00FDdnech l\u00E9\u010Dby. - zhodnotit \u00FA\u010Dinnost dvou d\u00E1vek apremilast (30 mg dvakr\u00E1t denn\u011B a 20 mg dvakr\u00E1t denn\u011B) na AS l\u00E9z\u00ED v oblasti kr\u010Dn\u00ED a bedern\u00ED p\u00E1te\u0159e z d\u016Fvodu posouzen\u00ED rentgenov\u00FDch sn\u00EDmk\u016F u pacient\u016F s aktivn\u00ED AS na 104 t\u00FDdn\u016F a 260 t\u00FDdn\u016F l\u00E9\u010Dby."@cs . "A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis"@en . "Vyhodnocen\u00ED \u00FA\u010Dinnosti apremilast 30 mg dvakr\u00E1t denn\u011B (BID), ve srovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F u pacient\u016F s aktivn\u00ED AS u 16 t\u00FDdnech l\u00E9\u010Dby Sekund\u00E1rn\u00ED c\u00EDle studie - zhodnotit \u00FA\u010Dinnost apremilast 30 mg dvakr\u00E1t denn\u011B, v porovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F, zlep\u0161en\u00ED fyzick\u00E9 funkce a rozsah pohybu u pacient\u016F s aktivn\u00ED AS po 24 t\u00FDdnech l\u00E9\u010Dby. - zhodnotit \u00FA\u010Dinnost apremilast 20 mg dvakr\u00E1t denn\u011B, ve srovn\u00E1n\u00ED s placebem, p\u0159i redukci zn\u00E1mek a p\u0159\u00EDznak\u016F, zlep\u0161en\u00ED fyzick\u00E9 funkce a rozsah pohybu u pacient\u016F s aktivn\u00ED AS po 24 t\u00FDdnech l\u00E9\u010Dby. - zhodnotit \u00FA\u010Dinnost dvou d\u00E1vek apremilast (30 mg dvakr\u00E1t denn\u011B a 20 mg dvakr\u00E1t denn\u011B) na AS l\u00E9z\u00ED v oblasti kr\u010Dn\u00ED a bedern\u00ED p\u00E1te\u0159e z d\u016Fvodu posouzen\u00ED rentgenov\u00FDch sn\u00EDmk\u016F u pacient\u016F s aktivn\u00ED AS na 104 t\u00FDdn\u016F a 260 t\u00FDdn\u016F l\u00E9\u010Dby." . "90001" . . "To evaluate the efficacy of apremilast 30 mg twice a day (BID), compared with placebo, in the reduction of signs and symptoms in subjects with active AS at 16 weeks of treatment Secondary objectives of the trial - To evaluate the efficacy of apremilast 30 mg BID, compared with placebo, in the reduction of signs and symptoms, improvement in physical function and range of motion in subjects with active AS at 24 weeks of treatment. - To evaluate the efficacy of apremilast 20 mg BID, compared with placebo, in the reduction of signs and symptoms, improvement in physical function and range of motion in subjects with active AS at 24 weeks of treatment. - To evaluate the efficacy of two doses of apremilast (30 mg BID and 20 mg BID) on AS lesions in the cervical and lumbar spine as assessed by radiographs in subjects with active AS at 104 Weeks and 260 Weeks of treatment."@en . "Multicentrick\u00E9, randomizovan\u00E9, dvojit\u011B zaslepen\u00E9, placebem kontrolovan\u00E9 klinick\u00E9 hodnocen\u00ED f\u00E1ze 3 s paraleln\u00EDmi skupinami posuzuj\u00EDc\u00ED \u00FA\u010Dinnost a bezpe\u010Dnost apremilastu (CC-10004) v l\u00E9\u010Db\u011B aktivn\u00ED ankylozuj\u00EDc\u00ED spondylitidy"@cs . "RIV/00064190:_____/13:#0000730!RIV14-MZ0-00064190" . . "Celgene Corporation" . .