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An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518620
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 19, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: ALX-0061
Enrollment 406
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects)
Hide Arm/Group Description ALX-0061 150 mg s.c. q2w + methotrexate (MTX) ALX-0061 150 mg s.c. q2w
Period Title: Overall Study
Started 257 149
Completed 205 123
Not Completed 52 26
Reason Not Completed
Adverse Event             23             11
Lack of Efficacy             2             0
Non-Compliance with Study Drug             1             0
Physician Decision             1             1
Sponsor's Decision             0             3
Lost to Follow-up             1             1
Withdrawal by Subject             17             9
Death             1             0
Pregnancy Wish             3             0
Pregnancy             1             0
Relocation             2             1
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total
Hide Arm/Group Description ALX-0061 150 mg s.c. q2w + MTX ALX-0061 150 mg s.c. q2w Total of all reporting groups
Overall Number of Baseline Participants 257 149 406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 149 participants 406 participants
<=18 years
1
   0.4%
1
   0.7%
2
   0.5%
Between 18 and 65 years
212
  82.5%
127
  85.2%
339
  83.5%
>=65 years
44
  17.1%
21
  14.1%
65
  16.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants 149 participants 406 participants
51.7  (12.26) 51.1  (12.01) 51.5  (12.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 149 participants 406 participants
Female
217
  84.4%
124
  83.2%
341
  84.0%
Male
40
  15.6%
25
  16.8%
65
  16.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 149 participants 406 participants
Hispanic or Latino
53
  20.6%
21
  14.1%
74
  18.2%
Not Hispanic or Latino
204
  79.4%
128
  85.9%
332
  81.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 149 participants 406 participants
American Indian or Alaska Native
12
   4.7%
0
   0.0%
12
   3.0%
Asian
1
   0.4%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
244
  94.9%
149
 100.0%
393
  96.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 257 participants 149 participants 406 participants
Romania 2 1 3
Belgium 9 7 16
Hungary 20 6 26
Poland 81 24 105
Mexico 52 21 73
Macedonia 9 12 21
Moldova 4 18 22
Georgia 35 30 65
Bulgaria 23 15 38
Serbia 20 12 32
Germany 0 1 1
Spain 2 2 4
1.Primary Outcome
Title Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 251 participants 149 participants 400 participants
224
  89.2%
126
  84.6%
350
  87.5%
Week 12 Number Analyzed 246 participants 141 participants 387 participants
221
  89.8%
130
  92.2%
351
  90.7%
Week 48 Number Analyzed 223 participants 134 participants 357 participants
209
  93.7%
126
  94.0%
335
  93.8%
Week 104 Number Analyzed 199 participants 123 participants 322 participants
193
  97.0%
117
  95.1%
310
  96.3%
2.Primary Outcome
Title Number and Percentage of Subjects With ACR50 Response.
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 246 participants 148 participants 394 participants
152
  61.8%
70
  47.3%
222
  56.3%
Week 12 Number Analyzed 244 participants 141 participants 385 participants
174
  71.3%
88
  62.4%
262
  68.1%
Week 48 Number Analyzed 222 participants 134 participants 356 participants
170
  76.6%
108
  80.6%
278
  78.1%
Week 104 Number Analyzed 198 participants 123 participants 321 participants
167
  84.3%
104
  84.6%
271
  84.4%
3.Primary Outcome
Title Number and Percentage of Subjects With ACR70 Response.
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 249 participants 147 participants 396 participants
85
  34.1%
33
  22.4%
118
  29.8%
Week 12 Number Analyzed 243 participants 141 participants 384 participants
107
  44.0%
51
  36.2%
158
  41.1%
Week 48 Number Analyzed 221 participants 133 participants 354 participants
135
  61.1%
66
  49.6%
201
  56.8%
Week 104 Number Analyzed 197 participants 123 participants 320 participants
136
  69.0%
89
  72.4%
225
  70.3%
4.Primary Outcome
Title ACR-N Index of Improvement
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Mean (Standard Error)
Unit of Measure: percent improvement
Week 0 Number Analyzed 256 participants 149 participants 405 participants
55.77  (1.703) 48.18  (2.171) 52.98  (1.351)
Week 12 Number Analyzed 252 participants 142 participants 394 participants
61.51  (1.643) 57.07  (2.181) 59.91  (1.315)
Week 48 Number Analyzed 228 participants 135 participants 363 participants
67.73  (1.691) 66.49  (2.048) 67.27  (1.306)
Week 104 Number Analyzed 205 participants 123 participants 328 participants
74.83  (1.554) 73.82  (2.171) 74.45  (1.265)
5.Primary Outcome
Title 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)
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 253 participants 148 participants 401 participants
Remission
101
  39.9%
51
  34.5%
152
  37.9%
Low Disease Activity
39
  15.4%
26
  17.6%
65
  16.2%
Moderate or High Disease Activity
113
  44.7%
71
  48.0%
184
  45.9%
Week 12 Number Analyzed 248 participants 138 participants 386 participants
Remission
142
  57.3%
67
  48.6%
209
  54.1%
Low Disease Activity
38
  15.3%
20
  14.5%
58
  15.0%
Moderate or High Disease Activity
68
  27.4%
51
  37.0%
119
  30.8%
Week 48 Number Analyzed 220 participants 132 participants 352 participants
Remission
139
  63.2%
70
  53.0%
209
  59.4%
Low Disease Activity
30
  13.6%
27
  20.5%
57
  16.2%
Moderate or High Disease Activity
51
  23.2%
35
  26.5%
86
  24.4%
Week 104 Number Analyzed 198 participants 121 participants 319 participants
Remission
146
  73.7%
84
  69.4%
230
  72.1%
Low Disease Activity
28
  14.1%
12
   9.9%
40
  12.5%
Moderate or High Disease Activity
24
  12.1%
25
  20.7%
49
  15.4%
6.Primary Outcome
Title Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
Hide Description

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.
Time Frame At Weeks 0, 12, 48, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITO Population
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total (C203 All Subjects)
Hide Arm/Group Description:
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg q2w
C203 All Subjects
Overall Number of Participants Analyzed 257 149 406
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 256 participants 149 participants 405 participants
DAS(CRP) < 2.6
100
  39.1%
49
  32.9%
149
  36.8%
Low Disease Activity
53
  20.7%
34
  22.8%
87
  21.5%
Moderate or High Disease Activity
103
  40.2%
66
  44.3%
169
  41.7%
Week 12 Number Analyzed 249 participants 142 participants 391 participants
DAS(CRP) < 2.6
150
  60.2%
73
  51.4%
223
  57.0%
Low Disease Activity
41
  16.5%
23
  16.2%
64
  16.4%
Moderate or High Disease Activity
58
  23.3%
46
  32.4%
104
  26.6%
Week 48 Number Analyzed 228 participants 134 participants 362 participants
DAS(CRP) < 2.6
153
  67.1%
78
  58.2%
231
  63.8%
Low Disease Activity
40
  17.5%
26
  19.4%
66
  18.2%
Moderate or High Disease Activity
35
  15.4%
30
  22.4%
65
  18.0%
Week 104 Number Analyzed 204 participants 123 participants 327 participants
DAS(CRP) < 2.6
160
  78.4%
92
  74.8%
252
  77.1%
Low Disease Activity
28
  13.7%
20
  16.3%
48
  14.7%
Moderate or High Disease Activity
16
   7.8%
11
   8.9%
27
   8.3%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total
Hide Arm/Group Description ALX-0061 150 mg s.c. q2w + MTX ALX-0061 150 mg s.c. q2w C203 All Subjects
All-Cause Mortality
ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/257 (0.78%)      0/148 (0.00%)      2/405 (0.49%)    
Hide Serious Adverse Events
ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/257 (9.73%)      9/148 (6.08%)      34/405 (8.40%)    
Cardiac disorders       
Acute myocardial infarction † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Angina pectoris † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Cardiac failure chronic † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Congenital, familial and genetic disorders       
Hydrocele † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Gastrointestinal disorders       
Abdominal pain † 1  1/257 (0.39%)  1 1/148 (0.68%)  1 2/405 (0.49%)  2
Pancreatitis acute † 1  2/257 (0.78%)  2 0/148 (0.00%)  0 2/405 (0.49%)  2
Abdominal pain lower † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
General disorders       
Systemic inflammatory response syndrome † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Hepatobiliary disorders       
Cholecystitis acute † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Infections and infestations       
Cellulitis † 1  1/257 (0.39%)  1 2/148 (1.35%)  2 3/405 (0.74%)  3
Pneumonia † 1  3/257 (1.17%)  3 0/148 (0.00%)  0 3/405 (0.74%)  3
Abscess neck † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Anal abscess † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Diverticulitis † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Erysipelas † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Pulmonary tuberculosis † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Retroperitoneal abscess † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Sepsis † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Septic shock † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Staphylococcal sepsis † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Injury, poisoning and procedural complications       
Ankle fracture † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Humerus fracture † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Patella fracture † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Radius fracture † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Invasive ductal breast carcinoma † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Plasma cell myeloma † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Testicular seminoma (pure) † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Nervous system disorders       
Headache † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Transient ischemic attack † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Reproductive system and breast disorders       
Ovarian cyst † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Skin and subcutaneous tissue disorders       
Diabetic foot † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Skin ulcer † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
Vascular disorders       
Extremity necrosis † 1  0/257 (0.00%)  0 1/148 (0.68%)  1 1/405 (0.25%)  1
Hypertensive crisis † 1  1/257 (0.39%)  1 0/148 (0.00%)  0 1/405 (0.25%)  1
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg q2w (C202 All Subjects) Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   122/257 (47.47%)      96/148 (64.86%)      218/405 (53.83%)    
Gastrointestinal disorders       
Diarrhea † 1  12/257 (4.67%)  12 8/148 (5.41%)  8 20/405 (4.94%)  20
General disorders       
Injection site erythema † 1  14/257 (5.45%)  28 11/148 (7.43%)  23 25/405 (6.17%)  51
Infections and infestations       
Upper respiratory tract infection † 1  23/257 (8.95%)  31 12/148 (8.11%)  13 35/405 (8.64%)  44
Nasopharyngitis † 1  17/257 (6.61%)  22 11/148 (7.43%)  13 28/405 (6.91%)  35
Pharyngitis † 1  15/257 (5.84%)  19 9/148 (6.08%)  11 24/405 (5.93%)  30
Urinary tract infection † 1  14/257 (5.45%)  17 9/148 (6.08%)  13 23/405 (5.68%)  30
Influenza † 1  8/257 (3.11%)  12 10/148 (6.76%)  17 18/405 (4.44%)  29
Metabolism and nutrition disorders       
Hypercholesterolemia † 1  6/257 (2.33%)  6 9/148 (6.08%)  9 15/405 (3.70%)  15
Nervous system disorders       
Headache † 1  4/257 (1.56%)  5 9/148 (6.08%)  13 13/405 (3.21%)  18
Vascular disorders       
Hypertension † 1  9/257 (3.50%)  9 8/148 (5.41%)  8 17/405 (4.20%)  17
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Medical Monitor
Organization: Ablynx NV
Phone: +32 (0)9 262 00 00
EMail: clinicaltrials@ablynx.com
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Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02518620    
Other Study ID Numbers: ALX0061-C203
2014-003034-42 ( EudraCT Number )
First Submitted: August 6, 2015
First Posted: August 10, 2015
Results First Submitted: April 23, 2019
Results First Posted: July 19, 2019
Last Update Posted: July 30, 2019