Trial Outcomes & Findings for An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis (NCT NCT02518620)
NCT ID: NCT02518620
Last Updated: 2019-07-30
Results Overview
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
406 participants
Primary outcome timeframe
At Weeks 0, 12, 48, and 104
Results posted on
2019-07-30
Participant Flow
A total of 406 subjects was enrolled at 56 sites located in Europe (48 sites, 333 subjects) and Latin America (8 sites, 73 subjects). Consent was obtained from the first subject on 13 July 2015; the last subject completed the final visit on 23 August 2018.
A total of 472 subjects completed the entire treatment and assessment period of the preceding Phase IIb studies (placebo and ALX-0061 treatment arms only). Of these, 406 subjects were enrolled in this study. All screened subjects were included in the Intent-to-observe (ITO) Population. Overall, 405 subjects were included in the Safety Population.
Participant milestones
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
ALX-0061 150 mg s.c. q2w + methotrexate (MTX)
|
ALX-0061 150 mg q2w (C202 All Subjects)
ALX-0061 150 mg s.c. q2w
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
149
|
|
Overall Study
COMPLETED
|
205
|
123
|
|
Overall Study
NOT COMPLETED
|
52
|
26
|
Reasons for withdrawal
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
ALX-0061 150 mg s.c. q2w + methotrexate (MTX)
|
ALX-0061 150 mg q2w (C202 All Subjects)
ALX-0061 150 mg s.c. q2w
|
|---|---|---|
|
Overall Study
Adverse Event
|
23
|
11
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Sponsor's Decision
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
9
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Pregnancy Wish
|
3
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Relocation
|
2
|
1
|
Baseline Characteristics
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg s.c. q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg s.c. q2w
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
212 Participants
n=39 Participants
|
127 Participants
n=41 Participants
|
339 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 12.26 • n=39 Participants
|
51.1 years
STANDARD_DEVIATION 12.01 • n=41 Participants
|
51.5 years
STANDARD_DEVIATION 12.15 • n=35 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=39 Participants
|
124 Participants
n=41 Participants
|
341 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
74 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
204 Participants
n=39 Participants
|
128 Participants
n=41 Participants
|
332 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
244 Participants
n=39 Participants
|
149 Participants
n=41 Participants
|
393 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=39 Participants
|
1 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=39 Participants
|
7 participants
n=41 Participants
|
16 participants
n=35 Participants
|
|
Region of Enrollment
Hungary
|
20 participants
n=39 Participants
|
6 participants
n=41 Participants
|
26 participants
n=35 Participants
|
|
Region of Enrollment
Poland
|
81 participants
n=39 Participants
|
24 participants
n=41 Participants
|
105 participants
n=35 Participants
|
|
Region of Enrollment
Mexico
|
52 participants
n=39 Participants
|
21 participants
n=41 Participants
|
73 participants
n=35 Participants
|
|
Region of Enrollment
Macedonia
|
9 participants
n=39 Participants
|
12 participants
n=41 Participants
|
21 participants
n=35 Participants
|
|
Region of Enrollment
Moldova
|
4 participants
n=39 Participants
|
18 participants
n=41 Participants
|
22 participants
n=35 Participants
|
|
Region of Enrollment
Georgia
|
35 participants
n=39 Participants
|
30 participants
n=41 Participants
|
65 participants
n=35 Participants
|
|
Region of Enrollment
Bulgaria
|
23 participants
n=39 Participants
|
15 participants
n=41 Participants
|
38 participants
n=35 Participants
|
|
Region of Enrollment
Serbia
|
20 participants
n=39 Participants
|
12 participants
n=41 Participants
|
32 participants
n=35 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
Week 0
|
224 Participants
|
126 Participants
|
350 Participants
|
|
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
Week 12
|
221 Participants
|
130 Participants
|
351 Participants
|
|
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
Week 48
|
209 Participants
|
126 Participants
|
335 Participants
|
|
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
Week 104
|
193 Participants
|
117 Participants
|
310 Participants
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
ACR50 response is defined as: * 50% improvement in TJC (68 joints) relative to Week 0 AND * 50% improvement in SJC (66 joints) relative to Week 0 AND * 50% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
Number and Percentage of Subjects With ACR50 Response.
Week 0
|
152 Participants
|
70 Participants
|
222 Participants
|
|
Number and Percentage of Subjects With ACR50 Response.
Week 12
|
174 Participants
|
88 Participants
|
262 Participants
|
|
Number and Percentage of Subjects With ACR50 Response.
Week 48
|
170 Participants
|
108 Participants
|
278 Participants
|
|
Number and Percentage of Subjects With ACR50 Response.
Week 104
|
167 Participants
|
104 Participants
|
271 Participants
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
ACR70 response is defined as: * 70% improvement in TJC (68 joints) relative to Week 0 AND * 70% improvement in SJC (66 joints) relative to Week 0 AND * 70% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
Number and Percentage of Subjects With ACR70 Response.
Week 0
|
85 Participants
|
33 Participants
|
118 Participants
|
|
Number and Percentage of Subjects With ACR70 Response.
Week 12
|
107 Participants
|
51 Participants
|
158 Participants
|
|
Number and Percentage of Subjects With ACR70 Response.
Week 48
|
135 Participants
|
66 Participants
|
201 Participants
|
|
Number and Percentage of Subjects With ACR70 Response.
Week 104
|
136 Participants
|
89 Participants
|
225 Participants
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria: * The percent improvement from Week 0 in TJCs * The percent improvement from Week 0 in SJCs * The median percent improvement from Week 0 for the following 5 assessments: * Subject's assessment of pain (VAS) * Subject's global assessment of disease activity (VASPHA) * Physician's global assessment of disease activity (VASPHA) * Subject's assessment of physical function as measured by the HAQ-DI * CRP level ACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
ACR-N Index of Improvement
Week 0
|
55.77 percent improvement
Standard Error 1.703
|
48.18 percent improvement
Standard Error 2.171
|
52.98 percent improvement
Standard Error 1.351
|
|
ACR-N Index of Improvement
Week 12
|
61.51 percent improvement
Standard Error 1.643
|
57.07 percent improvement
Standard Error 2.181
|
59.91 percent improvement
Standard Error 1.315
|
|
ACR-N Index of Improvement
Week 48
|
67.73 percent improvement
Standard Error 1.691
|
66.49 percent improvement
Standard Error 2.048
|
67.27 percent improvement
Standard Error 1.306
|
|
ACR-N Index of Improvement
Week 104
|
74.83 percent improvement
Standard Error 1.554
|
73.82 percent improvement
Standard Error 2.171
|
74.45 percent improvement
Standard Error 1.265
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln\[ESR\]) +(0.014 × VASPA) * Remission = DAS28(ESR) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 0 · Moderate or High Disease Activity
|
113 Participants
|
71 Participants
|
184 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 48 · Low Disease Activity
|
30 Participants
|
27 Participants
|
57 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 48 · Moderate or High Disease Activity
|
51 Participants
|
35 Participants
|
86 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 0 · Remission
|
101 Participants
|
51 Participants
|
152 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 0 · Low Disease Activity
|
39 Participants
|
26 Participants
|
65 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 12 · Remission
|
142 Participants
|
67 Participants
|
209 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 12 · Low Disease Activity
|
38 Participants
|
20 Participants
|
58 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 12 · Moderate or High Disease Activity
|
68 Participants
|
51 Participants
|
119 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 48 · Remission
|
139 Participants
|
70 Participants
|
209 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 104 · Remission
|
146 Participants
|
84 Participants
|
230 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 104 · Low Disease Activity
|
28 Participants
|
12 Participants
|
40 Participants
|
|
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
Week 104 · Moderate or High Disease Activity
|
24 Participants
|
25 Participants
|
49 Participants
|
PRIMARY outcome
Timeframe: At Weeks 0, 12, 48, and 104Population: ITO Population
DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln\[CRP+1\]) + (0.014 × VASPA) + 0.96 * DAS28(CRP) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Outcome measures
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 Participants
ALX-0061 150 mg q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=149 Participants
ALX-0061 150 mg q2w
|
Total (C203 All Subjects)
n=406 Participants
C203 All Subjects
|
|---|---|---|---|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 104 · Moderate or High Disease Activity
|
16 Participants
|
11 Participants
|
27 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 12 · Low Disease Activity
|
41 Participants
|
23 Participants
|
64 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 12 · Moderate or High Disease Activity
|
58 Participants
|
46 Participants
|
104 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 48 · DAS(CRP) < 2.6
|
153 Participants
|
78 Participants
|
231 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 48 · Low Disease Activity
|
40 Participants
|
26 Participants
|
66 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 48 · Moderate or High Disease Activity
|
35 Participants
|
30 Participants
|
65 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 104 · DAS(CRP) < 2.6
|
160 Participants
|
92 Participants
|
252 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 104 · Low Disease Activity
|
28 Participants
|
20 Participants
|
48 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 0 · DAS(CRP) < 2.6
|
100 Participants
|
49 Participants
|
149 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 0 · Low Disease Activity
|
53 Participants
|
34 Participants
|
87 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 0 · Moderate or High Disease Activity
|
103 Participants
|
66 Participants
|
169 Participants
|
|
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Week 12 · DAS(CRP) < 2.6
|
150 Participants
|
73 Participants
|
223 Participants
|
Adverse Events
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
Serious events: 25 serious events
Other events: 122 other events
Deaths: 2 deaths
ALX-0061 150 mg q2w (C202 All Subjects)
Serious events: 9 serious events
Other events: 96 other events
Deaths: 0 deaths
Total
Serious events: 34 serious events
Other events: 218 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 participants at risk
ALX-0061 150 mg s.c. q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=148 participants at risk
ALX-0061 150 mg s.c. q2w
|
Total
n=405 participants at risk
C203 All Subjects
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
1.4%
2/148 • Number of events 2 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.74%
3/405 • Number of events 3 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Pneumonia
|
1.2%
3/257 • Number of events 3 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.74%
3/405 • Number of events 3 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Anal abscess
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Erysipelas
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Sepsis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Septic shock
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.49%
2/405 • Number of events 2 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.78%
2/257 • Number of events 2 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.49%
2/405 • Number of events 2 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular seminoma (pure)
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Nervous system disorders
Transient ischemic attack
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/257 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.68%
1/148 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.39%
1/257 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.00%
0/148 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
0.25%
1/405 • Number of events 1 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
Other adverse events
| Measure |
ALX-0061 150 mg q2w + MTX (C201 All Subjects)
n=257 participants at risk
ALX-0061 150 mg s.c. q2w + MTX
|
ALX-0061 150 mg q2w (C202 All Subjects)
n=148 participants at risk
ALX-0061 150 mg s.c. q2w
|
Total
n=405 participants at risk
C203 All Subjects
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
23/257 • Number of events 31 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
8.1%
12/148 • Number of events 13 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
8.6%
35/405 • Number of events 44 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
17/257 • Number of events 22 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
7.4%
11/148 • Number of events 13 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.9%
28/405 • Number of events 35 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Pharyngitis
|
5.8%
15/257 • Number of events 19 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.1%
9/148 • Number of events 11 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
5.9%
24/405 • Number of events 30 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
14/257 • Number of events 17 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.1%
9/148 • Number of events 13 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
5.7%
23/405 • Number of events 30 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Infections and infestations
Influenza
|
3.1%
8/257 • Number of events 12 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.8%
10/148 • Number of events 17 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
4.4%
18/405 • Number of events 29 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
12/257 • Number of events 12 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
5.4%
8/148 • Number of events 8 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
4.9%
20/405 • Number of events 20 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
2.3%
6/257 • Number of events 6 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.1%
9/148 • Number of events 9 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
3.7%
15/405 • Number of events 15 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
General disorders
Injection site erythema
|
5.4%
14/257 • Number of events 28 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
7.4%
11/148 • Number of events 23 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.2%
25/405 • Number of events 51 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Nervous system disorders
Headache
|
1.6%
4/257 • Number of events 5 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
6.1%
9/148 • Number of events 13 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
3.2%
13/405 • Number of events 18 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
|
Vascular disorders
Hypertension
|
3.5%
9/257 • Number of events 9 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
5.4%
8/148 • Number of events 8 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
4.2%
17/405 • Number of events 17 • From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of any results from this study will be according to the principles of the Declaration of Helsinki, in particular point 30, and will require prior review and written agreement of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER