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Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (NEXUS)

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ClinicalTrials.gov Identifier: NCT02379091
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Namilumab
Drug: Placebo
Drug: Methotrexate
Drug: Folic/folinic acid
Enrollment 108
Recruitment Details Participants took part in the study at 28 investigative sites in Bulgaria, Czech Republic, Japan, Poland, Russian Federation, Spain and the United Kingdom from 17 December 2014 to 05 December 2016.
Pre-assignment Details Participants with a diagnosis of moderate to severe Rheumatoid Arthritis were enrolled equally in one of 4 treatment groups: placebo or 20, 80, 150 mg/mL namilumab.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Period Title: Overall Study
Started 27 28 25 28
Full Analysis Set 26 [1] 28 24 [1] 28
Completed 15 18 18 14
Not Completed 12 10 7 14
Reason Not Completed
Pretreatment Event/Adverse Event             0             2             0             1
Principal Investigator Discretion             0             1             0             0
Lost to Follow-up             0             0             0             1
Voluntary Withdrawal             2             5             2             4
Study Termination             7             2             5             8
Lack of Efficacy             3             0             0             0
[1]
One participant was excluded because of data collection issues.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL Total
Hide Arm/Group Description Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Total of all reporting groups
Overall Number of Baseline Participants 27 28 25 28 108
Hide Baseline Analysis Population Description
Safety analysis set includes all participants who received at least 1 dose of double-blind study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
47.2  (13.45) 46.1  (10.07) 49.0  (9.60) 51.3  (14.13) 48.4  (12.02)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
< 45 years
9
  33.3%
11
  39.3%
7
  28.0%
7
  25.0%
34
  31.5%
45 to 64 years
15
  55.6%
16
  57.1%
17
  68.0%
19
  67.9%
67
  62.0%
65 to 74 years
1
   3.7%
1
   3.6%
1
   4.0%
2
   7.1%
5
   4.6%
>= 75 years
2
   7.4%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
Female
23
  85.2%
22
  78.6%
17
  68.0%
22
  78.6%
84
  77.8%
Male
4
  14.8%
6
  21.4%
8
  32.0%
6
  21.4%
24
  22.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
Hispanic or Latino
1
   3.7%
2
   7.1%
1
   4.0%
0
   0.0%
4
   3.7%
Not Hispanic or Latino
22
  81.5%
22
  78.6%
21
  84.0%
23
  82.1%
88
  81.5%
Unknown or Not Reported
4
  14.8%
4
  14.3%
3
  12.0%
5
  17.9%
16
  14.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
Asian
6
  22.2%
4
  14.3%
3
  12.0%
5
  17.9%
18
  16.7%
White
21
  77.8%
24
  85.7%
22
  88.0%
22
  78.6%
89
  82.4%
Multiracial
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
1
   0.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
Bulgaria
2
   7.4%
1
   3.6%
1
   4.0%
1
   3.6%
5
   4.6%
Czech Republic
7
  25.9%
9
  32.1%
9
  36.0%
10
  35.7%
35
  32.4%
Japan
4
  14.8%
4
  14.3%
3
  12.0%
5
  17.9%
16
  14.8%
Poland
1
   3.7%
6
  21.4%
4
  16.0%
2
   7.1%
13
  12.0%
Russia
7
  25.9%
4
  14.3%
6
  24.0%
9
  32.1%
26
  24.1%
Spain
1
   3.7%
2
   7.1%
1
   4.0%
0
   0.0%
4
   3.7%
United Kingdom
5
  18.5%
2
   7.1%
1
   4.0%
1
   3.6%
9
   8.3%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
164.3  (10.51) 167.7  (6.65) 167.4  (8.36) 166.5  (9.24) 166.5  (8.78)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
63.89  (14.511) 70.28  (15.911) 76.56  (18.660) 72.23  (19.168) 70.64  (17.499)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
23.75  (5.542) 24.91  (5.210) 27.16  (5.605) 25.92  (6.313) 25.41  (5.741)
BMI Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
< 30 kg/m^2
24
  88.9%
23
  82.1%
16
  64.0%
22
  78.6%
85
  78.7%
>= 30 kg/m^2
3
  11.1%
5
  17.9%
9
  36.0%
6
  21.4%
23
  21.3%
Smoking classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 25 participants 28 participants 108 participants
Participant has never smoked
16
  59.3%
19
  67.9%
18
  72.0%
18
  64.3%
71
  65.7%
Participant is a current smoker
6
  22.2%
5
  17.9%
5
  20.0%
6
  21.4%
22
  20.4%
Participant is an ex-smoker
5
  18.5%
4
  14.3%
2
   8.0%
4
  14.3%
15
  13.9%
1.Primary Outcome
Title Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12
Hide Description The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in double-blind period up to Week 12, with data available at Baseline and Week 12 for analysis.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 24 25 22 26
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.77  (0.294) -1.38  (0.288) -1.36  (0.302) -1.69  (0.286)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Namilumab 20 mg/mL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.
Method ANOVA
Comments Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.31 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.351
Estimation Comments Namilumab - Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Namilumab 80 mg/mL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.
Method ANOVA
Comments Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.32 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.366
Estimation Comments Namilumab - Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Namilumab 150 mg/mL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.
Method ANOVA
Comments Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.61 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.347
Estimation Comments Namilumab - Placebo
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
Hide Description

ACR20/50/70 response is defined as a ≥20/50/70% reduction from Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), and the following:

  • Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain
  • Patient's Global Assessment of Disease Activity
  • Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity
  • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do
  • Acute-phase reactant: C-reactive Protein (CRP).
Time Frame Baseline and Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS includes all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 26 28 24 28
Measure Type: Number
Unit of Measure: percentage of participants
ACR 20, Week 12 Number Analyzed 24 participants 25 participants 23 participants 26 participants
37.5 72.0 52.2 53.8
ACR 50, Week 12 Number Analyzed 24 participants 25 participants 23 participants 26 participants
16.7 20.0 30.4 38.5
ACR 70, Week 12 Number Analyzed 24 participants 25 participants 23 participants 26 participants
8.3 4.0 21.7 15.4
ACR 20, Week 24 Number Analyzed 21 participants 23 participants 23 participants 25 participants
33.3 65.2 47.8 56.0
ACR 50, Week 24 Number Analyzed 21 participants 23 participants 23 participants 25 participants
23.8 34.8 47.8 36.0
ACR 70, Week 24 Number Analyzed 21 participants 23 participants 23 participants 25 participants
19.0 13.0 30.4 20.0
3.Secondary Outcome
Title ACR Numeric (N) Index (ACRn) at Week 12
Hide Description ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 24 25 23 26
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-17.25  (16.469) 3.97  (16.372) 19.68  (16.875) 17.14  (16.098)
4.Secondary Outcome
Title ACR Numeric (N) Index (ACRn) at Week 24
Hide Description ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.
Time Frame Baseline and Week 24
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Hide Analysis Population Description
Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Post-escape data is included.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 26 28 24 28
Mean (Standard Deviation)
Unit of Measure: percentage change
34.04  (40.248) 35.35  (50.191) 44.66  (38.203) 36.57  (38.709)
5.Secondary Outcome
Title Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10
Hide Description The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
Time Frame Baseline and Weeks 2, 6 and 10
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Hide Analysis Population Description
FAS includes all participants in the safety analysis set who had at least 1 valid postbaseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 26 28 24 28
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change at Week 2 Number Analyzed 26 participants 28 participants 23 participants 28 participants
-0.33  (0.236) -0.58  (0.222) -0.84  (0.245) -0.95  (0.224)
Change at Week 6 Number Analyzed 25 participants 26 participants 23 participants 27 participants
-0.70  (0.268) -1.13  (0.256) -1.37  (0.275) -1.42  (0.257)
Change at Week 10 Number Analyzed 25 participants 25 participants 22 participants 27 participants
-0.75  (0.280) -1.19  (0.273) -1.39  (0.289) -1.51  (0.269)
6.Secondary Outcome
Title Change From Baseline in DAS28-CRP at Week 24
Hide Description The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis at Baseline and Week 24.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 12 18 16 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.75  (1.401) -2.37  (1.083) -2.20  (1.219) -2.26  (0.962)
7.Secondary Outcome
Title Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24
Hide Description Reduction of Pain, defined as a ≥40% change from Baseline as measured using a 100 mm Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain at weeks 2, 12 and 24.
Time Frame Baseline and Week 2, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL
Hide Arm/Group Description:
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Overall Number of Participants Analyzed 26 28 24 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 26 participants 28 participants 23 participants 28 participants
7.7 14.3 8.7 3.6
Week 12 Number Analyzed 24 participants 25 participants 23 participants 26 participants
20.8 44.0 39.1 30.8
Week 24 Number Analyzed 22 participants 23 participants 23 participants 25 participants
22.7 43.5 47.8 24.0
Time Frame First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL Placebo to Namilumab 150 mg/mL Namilumab to Namilumab 150 mg/mL
Hide Arm/Group Description Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by Namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. Namilumab 20 or 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
All-Cause Mortality
Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL Placebo to Namilumab 150 mg/mL Namilumab to Namilumab 150 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL Placebo to Namilumab 150 mg/mL Namilumab to Namilumab 150 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/28 (0.00%)   1/25 (4.00%)   1/28 (3.57%)   0/12 (0.00%)   4/24 (16.67%) 
Cardiac disorders             
Angina pectoris  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  1/24 (4.17%) 
Myocardial infarction  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  1/28 (3.57%)  0/12 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders             
Mallory-Weiss syndrome  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  1/24 (4.17%) 
Injury, poisoning and procedural complications             
Ankle fracture  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  1/24 (4.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Breast cancer  1  0/27 (0.00%)  0/28 (0.00%)  1/25 (4.00%)  0/28 (0.00%)  0/12 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version: 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Namilumab 20 mg/mL Namilumab 80 mg/mL Namilumab 150 mg/mL Placebo to Namilumab 150 mg/mL Namilumab to Namilumab 150 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/27 (33.33%)   13/28 (46.43%)   12/25 (48.00%)   12/28 (42.86%)   5/12 (41.67%)   6/24 (25.00%) 
Blood and lymphatic system disorders             
Anaemia  1  1/27 (3.70%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Hepatobiliary disorders             
Drug-induced liver injury  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  2/24 (8.33%) 
Infections and infestations             
Nasopharyngitis  1  5/27 (18.52%)  7/28 (25.00%)  2/25 (8.00%)  5/28 (17.86%)  0/12 (0.00%)  1/24 (4.17%) 
Bronchitis  1  2/27 (7.41%)  1/28 (3.57%)  1/25 (4.00%)  1/28 (3.57%)  0/12 (0.00%)  0/24 (0.00%) 
Upper respiratory tract infection  1  0/27 (0.00%)  0/28 (0.00%)  2/25 (8.00%)  2/28 (7.14%)  0/12 (0.00%)  1/24 (4.17%) 
Laryngitis  1  0/27 (0.00%)  0/28 (0.00%)  2/25 (8.00%)  0/28 (0.00%)  0/12 (0.00%)  0/24 (0.00%) 
Lower respiratory tract infection  1  1/27 (3.70%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Oral herpes  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  1/12 (8.33%)  1/24 (4.17%) 
Investigations             
Activated partial thromboplastin time prolonged  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Forced expiratory volume decreased  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  2/24 (8.33%) 
White blood cell count decreased  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid arthritis  1  0/27 (0.00%)  2/28 (7.14%)  2/25 (8.00%)  0/28 (0.00%)  0/12 (0.00%)  1/24 (4.17%) 
Nervous system disorders             
Headache  1  1/27 (3.70%)  1/28 (3.57%)  3/25 (12.00%)  0/28 (0.00%)  0/12 (0.00%)  0/24 (0.00%) 
Reproductive system and breast disorders             
Menorrhagia  1  0/27 (0.00%)  2/28 (7.14%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnoea  1  0/27 (0.00%)  1/28 (3.57%)  2/25 (8.00%)  3/28 (10.71%)  1/12 (8.33%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders             
Urticaria  1  0/27 (0.00%)  2/28 (7.14%)  0/25 (0.00%)  0/28 (0.00%)  0/12 (0.00%)  0/24 (0.00%) 
Vascular disorders             
Hypertension  1  0/27 (0.00%)  0/28 (0.00%)  0/25 (0.00%)  2/28 (7.14%)  0/12 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version: 19.0
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.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02379091    
Other Study ID Numbers: M1-1188_202
U1111-1151-6931 ( Registry Identifier: WHO )
2013-002805-76 ( EudraCT Number )
14/SC/1252 ( Registry Identifier: NRES )
153300410A0071 ( Registry Identifier: RNEC )
JapicCTI-152979 ( Registry Identifier: JapicCTI )
First Submitted: November 28, 2014
First Posted: March 4, 2015
Results First Submitted: November 15, 2017
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018