Trial Outcomes & Findings for Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease (NCT NCT02096861)
NCT ID: NCT02096861
Last Updated: 2018-05-09
Results Overview
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
at Week 6
Results posted on
2018-05-09
Participant Flow
Participant milestones
| Measure |
CT-P13 - CT-P13
CT-P13 followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
CT-P13 - Remicade
CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
54
|
55
|
|
Overall Study
Drug Switching at Week 30
|
48
|
44
|
41
|
47
|
|
Overall Study
COMPLETED
|
44
|
40
|
37
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
17
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
CT-P13 - CT-P13
n=56 Participants
CT-P13 followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
CT-P13 - Remicade
n=55 Participants
CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 Participants
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 Participants
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Continuous
|
39 years
n=5 Participants
|
31 years
n=7 Participants
|
31 years
n=5 Participants
|
35 years
n=4 Participants
|
33 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
165 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Russia
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at Week 6Population: CT-P13 treatment group including CT-P13 - CT-P13 and CT-P13 - Remicade treatment groups. Remicade treatment group including Remicade - Remicade and Remicade - CT-P13 treatment groups.
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
Outcome measures
| Measure |
CT-P13
n=111 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=109 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
|
77 Participants
|
81 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Outcome measures
| Measure |
CT-P13
n=111 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=109 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
|
85 Participants
|
82 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Outcome measures
| Measure |
CT-P13
n=56 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=55 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 Participants
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 Participants
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
|
44 Participants
|
39 Participants
|
38 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Outcome measures
| Measure |
CT-P13
n=111 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=109 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Remission at Week 6
|
47 Participants
|
49 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Outcome measures
| Measure |
CT-P13
n=111 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=109 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Remission at Week 30
|
61 Participants
|
62 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54Clinical remission was defined as an absolute CDAI score of less than 150 points.
Outcome measures
| Measure |
CT-P13
n=56 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=55 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 Participants
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 Participants
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving Clinical Remission at Week 54
|
35 Participants
|
32 Participants
|
29 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to Week 30Population: Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit. CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.
Outcome measures
| Measure |
CT-P13
n=111 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=109 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Baseline
|
34.3 scores on a scale
Standard Deviation 10.92
|
33.9 scores on a scale
Standard Deviation 9.27
|
—
|
—
|
|
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Week 6
|
46.4 scores on a scale
Standard Deviation 10.86
|
45.8 scores on a scale
Standard Deviation 12.54
|
—
|
—
|
|
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Week 30
|
51.1 scores on a scale
Standard Deviation 11.96
|
52.5 scores on a scale
Standard Deviation 10.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.
Outcome measures
| Measure |
CT-P13
n=56 Participants
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade
n=55 Participants
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 Participants
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 Participants
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
The Short Inflammatory Bowel Disease Questionnaire
Baseline
|
34.7 scores on a scale
Standard Deviation 10.61
|
33.8 scores on a scale
Standard Deviation 11.31
|
33.3 scores on a scale
Standard Deviation 9.77
|
34.5 scores on a scale
Standard Deviation 8.81
|
|
The Short Inflammatory Bowel Disease Questionnaire
Week 54
|
54.4 scores on a scale
Standard Deviation 10.28
|
54.1 scores on a scale
Standard Deviation 11.07
|
52.6 scores on a scale
Standard Deviation 11.35
|
51.2 scores on a scale
Standard Deviation 11.26
|
Adverse Events
CT-P13 - CT-P13
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
CT-P13 - Remicade
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Remicade - Remicade
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Remicade - CT-P13
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P13 - CT-P13
n=56 participants at risk
CT-P13 followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
CT-P13 - Remicade
n=55 participants at risk
CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 participants at risk
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 participants at risk
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Anal fissure
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Anal abscess
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Peritoneal tuberculosis
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
General disorders
Generalised oedema
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Nervous system disorders
Syncope
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
Other adverse events
| Measure |
CT-P13 - CT-P13
n=56 participants at risk
CT-P13 followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
CT-P13 - Remicade
n=55 participants at risk
CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - Remicade
n=54 participants at risk
Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
Remicade - CT-P13
n=55 participants at risk
Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
3/56 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
14.5%
8/55 • Number of events 9 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
9.3%
5/54 • Number of events 7 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.3%
4/55 • Number of events 6 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Number of events 2 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.6%
3/54 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.8%
1/56 • Number of events 2 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.6%
3/54 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Influenza
|
3.6%
2/56 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.9%
1/54 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
9.1%
5/55 • Number of events 6 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
3/56 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.8%
1/56 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.4%
4/54 • Number of events 5 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.4%
3/56 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.6%
3/54 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
5/56 • Number of events 5 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
9.1%
5/55 • Number of events 5 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
9.3%
5/54 • Number of events 5 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.3%
4/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
14.3%
8/56 • Number of events 13 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
3.6%
2/55 • Number of events 2 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
9.3%
5/54 • Number of events 7 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.3%
4/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.4%
4/54 • Number of events 5 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.3%
4/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • Number of events 2 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/55 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
7.3%
4/55 • Number of events 4 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
Nervous system disorders
Headache
|
5.4%
3/56 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
3.7%
2/54 • Number of events 2 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
|
General disorders
Pyrexia
|
0.00%
0/56 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
5.5%
3/55 • Number of events 3 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
0.00%
0/54 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
1.8%
1/55 • Number of events 1 • Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
|
Additional Information
BoYoung Choi / Clinical Operation Team Leader
Celltrion, Inc.
Phone: +82-32-850-6594
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place