Trial Outcomes & Findings for Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (NCT NCT03487276)
NCT ID: NCT03487276
Last Updated: 2021-04-08
Results Overview
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
179 participants
Primary outcome timeframe
Week 16
Results posted on
2021-04-08
Participant Flow
The study consisted of a Main and an Extension Period. In the Main Period 175 subjects were planned to be randomized to receive double-blind treatment with IMP or Placebo in 1 of 5 treatment cohorts in a ratio of 1:1:1:1:1. The Extension Period started after the Week 16 Visit. According to the assessed HiSCR response at Week 16, patients were distributed to two IFX-1 dosing regimens: Week 16 HiSCR responders to 800 mg Q4W and Week 16 HiSCR non-responders to 800 mg Q2W.
Participant milestones
| Measure |
Cohort 1
Placebo
Placebo: Placebo
|
Cohort 2
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|
|
Main Period (16 Weeks)
STARTED
|
37
|
34
|
36
|
36
|
36
|
|
Main Period (16 Weeks)
COMPLETED
|
34
|
30
|
32
|
30
|
31
|
|
Main Period (16 Weeks)
NOT COMPLETED
|
3
|
4
|
4
|
6
|
5
|
|
Extension Period (28 Weeks)
STARTED
|
0
|
0
|
72
|
84
|
0
|
|
Extension Period (28 Weeks)
Number of Patients in Cohort 1 (Main Period) Crossed Over to Cohort 3 or 4
|
0
|
0
|
16
|
18
|
0
|
|
Extension Period (28 Weeks)
Number of Patients in Cohort 2 (Main Period) Crossed Over to Cohort 3 or 4
|
0
|
0
|
12
|
18
|
0
|
|
Extension Period (28 Weeks)
Number of Patients in Cohort 3 (Main Period) Crossed Over to Cohort 3 or 4
|
0
|
0
|
17
|
15
|
0
|
|
Extension Period (28 Weeks)
Number of Patients in Cohort 4 (Main Period) Crossed Over to Cohort 3 or 4
|
0
|
0
|
12
|
18
|
0
|
|
Extension Period (28 Weeks)
Number of Patients in Cohort 5 (Main Period) Crossed Over to Cohort 3 or 4
|
0
|
0
|
15
|
16
|
0
|
|
Extension Period (28 Weeks)
COMPLETED
|
0
|
0
|
67
|
54
|
0
|
|
Extension Period (28 Weeks)
NOT COMPLETED
|
0
|
0
|
5
|
30
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=36 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=34 Participants
Minimum Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=35 Participants
Low dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=36 Participants
Medium Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=36 Participants
High Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
174 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Age, Continuous
|
34.5 years
n=5 Participants
|
39.0 years
n=7 Participants
|
35.0 years
n=5 Participants
|
37.0 years
n=4 Participants
|
33.5 years
n=21 Participants
|
36.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
170 Participants
n=8 Participants
|
|
Ethnicity (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
|
0 Participants
n=8 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
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
152 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Region of Enrollment
Bulgaria
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Baseline AN (total abscess and inflammatory nodule) count
|
9.5 lesions
n=5 Participants
|
9.0 lesions
n=7 Participants
|
8.0 lesions
n=5 Participants
|
10.0 lesions
n=4 Participants
|
12.5 lesions
n=21 Participants
|
9.0 lesions
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Analysis was performed on the full analysis set (FAS) population
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
Outcome measures
| Measure |
Cohort 1
n=34 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=30 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=33 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=31 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=33 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
HiSCR Responder
|
16 Participants
|
12 Participants
|
17 Participants
|
12 Participants
|
15 Participants
|
—
|
—
|
|
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
HiSCR Non-responder
|
18 Participants
|
18 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on the full analysis set (FAS) population. Only patients with non-missing assessment at Week 12 were analyzed.
Endpoint of the percentage of patients with HiSCR at Week 12 was analyzed in the same way as the primary endpoint using the MCP-Mod procedure and the same definition of response.
Outcome measures
| Measure |
Cohort 1
n=34 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=31 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=33 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=32 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=32 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
HiSCR Responder
|
14 Participants
|
14 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
HiSCR Non-responder
|
20 Participants
|
17 Participants
|
21 Participants
|
19 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
The number of patients with flares analyzed in terms of ≥ 25% increase in abscess and inflammatory nodule (AN) count among patients with a minimum increase of 2 in AN count compared to Day 1 was analyzed by descriptive statistics by time point.
Outcome measures
| Measure |
Cohort 1
n=34 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=30 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=32 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=30 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=32 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=67 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=52 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Flares Relative to Day 1
Patient with flares
|
6 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Flares Relative to Day 1
Patient without flares
|
28 Participants
|
27 Participants
|
31 Participants
|
30 Participants
|
31 Participants
|
64 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
The absolute change from Day 1 will be analyzed by descriptive statistics by time point. The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.
Outcome measures
| Measure |
Cohort 1
n=33 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=28 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=30 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=28 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=31 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=64 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=49 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Absolute Change in Modified Sartorius Score (mSS) From Day 1.
|
-16.4 score on a scale
Standard Deviation 30.78
|
-17.5 score on a scale
Standard Deviation 48.43
|
-29.4 score on a scale
Standard Deviation 32.35
|
-22.9 score on a scale
Standard Deviation 52.00
|
-35.2 score on a scale
Standard Deviation 101.91
|
-47.9 score on a scale
Standard Deviation 70.87
|
-27.5 score on a scale
Standard Deviation 45.02
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
The absolute changes from baseline were analyzed by descriptive statistics by time point. The Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. The scale title for the NRS is points. Ratings for this item range from a minimum of 0 points (no skin pain) to a maximum of 10 points (skin pain as bad as you can imagine). The higher the score the more severe the disease/worse is the outcome.
Outcome measures
| Measure |
Cohort 1
n=29 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=23 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=24 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=22 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=21 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=32 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=28 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
|
-1.2 score on a scale
Standard Deviation 2.82
|
-0.1 score on a scale
Standard Deviation 2.68
|
-0.7 score on a scale
Standard Deviation 2.37
|
-1.5 score on a scale
Standard Deviation 2.92
|
-1.8 score on a scale
Standard Deviation 3.03
|
-1.5 score on a scale
Standard Deviation 2.94
|
-1.3 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 30% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=22 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=23 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=22 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=21 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=30 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=28 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving NRS30
|
7 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 50% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=22 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=23 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=22 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=21 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=30 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=28 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving NRS50.
|
6 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
The changes from Day 1 will be analyzed by descriptive statistics by time point. A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.
Outcome measures
| Measure |
Cohort 1
n=32 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=30 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=30 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=28 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=32 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=59 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=48 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
|
-1.5 score on a scale
Standard Deviation 6.11
|
0.6 score on a scale
Standard Deviation 6.39
|
-2.6 score on a scale
Standard Deviation 7.19
|
-5.0 score on a scale
Standard Deviation 5.90
|
-2.4 score on a scale
Standard Deviation 5.24
|
-1.5 score on a scale
Standard Deviation 7.18
|
-2.0 score on a scale
Standard Deviation 6.52
|
SECONDARY outcome
Timeframe: From Day 1 until Day 309Population: For the Main Period the safety analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed.
The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.
Outcome measures
| Measure |
Cohort 1
n=36 Participants
Placebo
Placebo: Placebo
|
Cohort 2
n=34 Participants
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 3
n=35 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 4
n=36 Participants
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Cohort 5
n=36 Participants
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=72 Participants
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=84 Participants
Low dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Safety Parameters (Adverse Events) Will be Assessed.
|
26 Participants
|
26 Participants
|
21 Participants
|
24 Participants
|
22 Participants
|
39 Participants
|
49 Participants
|
Adverse Events
Main Period: Cohort 1
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Main Period: Cohort 2
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Main Period: Cohort 3
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Main Period: Cohort 4
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Main Period: Cohort 5
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Extension Period: Cohort 3
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Extension Period: Cohort 4
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Period: Cohort 1
n=36 participants at risk
Placebo
Placebo: Placebo
|
Main Period: Cohort 2
n=34 participants at risk
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 3
n=35 participants at risk
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 4
n=36 participants at risk
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 5
n=36 participants at risk
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=72 participants at risk
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=84 participants at risk
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.4%
2/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Influenza
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
Other adverse events
| Measure |
Main Period: Cohort 1
n=36 participants at risk
Placebo
Placebo: Placebo
|
Main Period: Cohort 2
n=34 participants at risk
Minimum Dose IFX-1 (400 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 3
n=35 participants at risk
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 4
n=36 participants at risk
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Main Period: Cohort 5
n=36 participants at risk
High Dose IFX-1 (1200 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 3
n=72 participants at risk
Low dose IFX-1 (800 mg Q4W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
Extension Period: Cohort 4
n=84 participants at risk
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.7%
6/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.8%
4/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
17.1%
6/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.1%
4/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.3%
3/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
4/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
9.5%
8/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Influenza
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.3%
3/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
2/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.4%
2/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Pharyngitis
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
2/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.4%
2/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.7%
2/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Abscess
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.7%
2/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Bronchitis
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Immune system disorders
Gastroenteritis
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
13.9%
5/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.8%
4/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.7%
2/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
19.4%
7/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
16.7%
6/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.1%
8/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.9%
10/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.8%
3/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
General disorders
Fatigue
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.6%
3/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.3%
3/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.8%
4/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.7%
2/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
8.3%
3/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
2/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.4%
2/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.4%
2/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
3.6%
3/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
2/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
General disorders
Pain
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Nervous system disorders
Headache
|
16.7%
6/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.8%
4/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
11.1%
4/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
13.9%
5/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
4/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
7.1%
6/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Investigations
International normalised ratio increased
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
3.6%
3/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.9%
2/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
4.8%
4/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.9%
1/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.4%
1/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
4.8%
4/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.6%
2/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
2/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
1.2%
1/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/34 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
5.7%
2/35 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
2.8%
1/36 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/72 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
0.00%
0/84 • The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place