Feagan et al, 2005, none |
Dec 2000-Feb 2003 |
randomized, double-blind,
PBO-controlled study; n/a; none |
20, 2 (USA, Canada) |
6 wks |
181 |
181 |
UCCS of 5-9 pts, with a score of atleast 1 on stool frequency or
rectal bleeding, and MBS of at least 2 on sigmoidoscopy, with disease a
minimum of 25cm from anal verge; no prior therapy or 5-ASA if given for
>4 wks with stable dose for >2
wks |
At wk 6: UCCS of 0 or 1 and MBS of 0 or 1 without evidence of
rectal bleeding |
At wk 6: UCCS of 0 or 1 and MBS of 0 or 1 without
evidence of rectal bleeding |
Participants (n=181) were randomized 1:1:1
to receive low dose (n=58), high dose (n=60), or PBO (n=63) |
low dose:
0.5 mg/kg or high dose: 2 mg/kg |
Feagan et al, 2013, GEMINI I |
2008-2012 |
Randomized, double-blind,
PBO-controlled; phase 3; Millennium Pharmaceuticals, Inc. |
211, 34 |
52
wks |
895 |
895 |
Moderately to severely active UC; demonstrated in the
past 5 yrs inadequate response, loss of response, or intolerance to
immunomodulators and/or TNFi and/or CS |
At wk 6: reduction in complete
Mayo score of ≥ 3 pts and ≥30% from baseline with decrease in rectal
bleeding subscore of ≥1 pt or absolute rectal bleeding subscore of ≤1
pt. At 52 wks: complete Mayo score of ≤2 pts and no individual subscore
>1 pt |
At wk 6: reduction in complete Mayo score of ≥ 3
pts and ≥30% from baseline with decrease in rectal bleeding subscore of
≥1 pt or absolute rectal bleeding subscore of ≤1 pt. At 52 wks: complete
Mayo score of ≤2 pts and no individual subscore >1 pt |
Induction Phase (wk 0-6): Cohort 1 (n=374) randomized and treated with
double-blind VDZ (at wks 0,2), cohort 2 (n=521) treated with open-label
VDZ (at wks 0,2). Maintenance phase (wk 6-52): VDZ-treated subjects
cohort 1 and 2 who demonstrated CR (n=373) were randomized in a 1:1:1
ratio to double-blind Rx with VDZ q4w (n=125), VDZ administered q8w
(n=122) or PBO (n=126); VDZ who did not respond at 6 wks continued
open-label VDZ q4w (n=330) |
300 |
Sandborn et al, 2013, GEMINI II |
Dec 2008-May 2012 |
Randomized,
double-blind, PBO-controlled; phase 3; Millennium Pharmaceuticals, Inc. |
285 centers, 39 countries |
52 wks |
52 wks |
1115 |
Moderately to
severely active CD; involvement of the ileum and/or colon; demonstrated
in the past 5 yrs inadequate response, loss of response, or intolerance
to immunomodulators and/or TNFi and/or CS |
At wk 6: % of subjects
achieving CDAI <150 at wk 6; % of subjects with CDAI
100 pts below baseline. At wk 52: % of subjects with CDAI
<150 at 52 wks |
At wk 6: % of subjects achieving CDAI
<150 at wk 6; % of subjects with CDAI 100 pts below
baseline. At wk 52: % of subjects with CDAI <150 at 52
wks |
Induction Phase (wk 0-6): Cohort 1 (n=368) randomized and treated
with double-blind VDZ (at wks 0,2), cohort 2 (n=747) treated with
open-label VDZ (at wks 0,2). Maintenance phase (wks 6-52): VDZ-treated
subjects cohort 1 and 2 who demonstrated CR (n=461) were randomized in a
1:1:1 ratio to double-blind RX with VDZ q4w (n=154), VDZ administered
q8w (n=154) or PBO (n=153); VDZ who did not respond at wk 6 continued
open-label VDZ q4w (n=412) |
300 |
Sands et al, 2014, GEMINI III |
Nov 2010-Apr 2012 |
Randomized,
double-blind, PBO-controlled; phase 3; Takeda Pharmaceuticals
International, Inc. |
107, ? (listed continents: North America, Europe,
Asia, Africa, and Australia) |
16 wks |
16 wks |
416 |
Moderately to
severely active CD; involvement of the ileum and/or colon; demonstrated
in the past 5 yrs inadequate response, loss of response, or intolerance
to imunosuppressives and/or TNFi and/or CS |
At wk 6: % of subjects
within TNFi failure population with CDAI <150 |
At wk
6: % of subjects within TNFi failure population with CDAI
<150 |
Participants (n=416) were randomized 1:1 to
receive VDZ (n=209) or PBO (n=207) at wks 0,2,6 |
300 |
Motoya et al, 2019, none |
Feb 2014-Jun 2018 |
Takeda Pharmaceutical
Company Limited |
100, 1 (Japan) |
76 wks |
76 wks |
292 |
Total or L
sided UC atleast 6m prior to study; moderately or severely active UC;
meet failure criteria to atleast 1 of the following in prior 5y: CS, AZA
or 6-MP, TNFi |
At wk 10: reduction in complete Mayo score of ≥3 pts and
≥30% from baseline with decrease in rectal bleeding subscore of ≥1 pt
or absolute rectal bleeding subscore of ≤1 pt; at wk 60: complete Mayo
score of ≤2 pts and no individual subscore >1 pt |
Induction phase (wks 0-10): Cohort 1 (n=246) was randomized 2:1 to
receive VDZ (n=164) or PBO (n=82), cohort 2 (n=46) received VDZ only at
wks 0,2,6; subjects showing CR to VDZ at wk 10 (n=83) were randomized
1:1 to receive VDZ (n=41) or PBO (n=42) at wk 14 then q8w up to 54 wks |
Induction phase (wks 0-10): Cohort 1 (n=246) was randomized 2:1 to
receive VDZ (n=164) or PBO (n=82), cohort 2 (n=46) received VDZ only at
wks 0,2,6; subjects showing CR to VDZ at wk 10 (n=83) were randomized
1:1 to receive VDZ (n=41) or PBO (n=42) at wk 14 then q8w up to 54 wks |
300 |