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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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
Arm/Group Description	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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.

Baseline Characteristics

Arm/Group Title		Placebo	Namilumab 20 mg/mL	Namilumab 80 mg/mL	Namilumab 150 mg/mL	Total
Arm/Group Description		Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12
Description	The DAS28-CRP score is a measure of the participant's disease activity...
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

Outcome Measure Data

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
Arm/Group Description:	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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)

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

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

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
Description	ACR20/50/70 response is defined as a ≥20/50/70% reduction from B...
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

Outcome Measure Data

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
Arm/Group Description:		Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
ACR 20, Week 12		37.5	72.0	52.2	53.8
ACR 50, Week 12	Number Analyzed	24 participants	25 participants	23 participants	26 participants
ACR 50, Week 12		16.7	20.0	30.4	38.5
ACR 70, Week 12	Number Analyzed	24 participants	25 participants	23 participants	26 participants
ACR 70, Week 12		8.3	4.0	21.7	15.4
ACR 20, Week 24	Number Analyzed	21 participants	23 participants	23 participants	25 participants
ACR 20, Week 24		33.3	65.2	47.8	56.0
ACR 50, Week 24	Number Analyzed	21 participants	23 participants	23 participants	25 participants
ACR 50, Week 24		23.8	34.8	47.8	36.0
ACR 70, Week 24	Number Analyzed	21 participants	23 participants	23 participants	25 participants
ACR 70, Week 24		19.0	13.0	30.4	20.0

3.Secondary Outcome


Title	ACR Numeric (N) Index (ACRn) at Week 12
Description	ACRn is defined as the lowest % improvement for TJC68, SJC66 and the m...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	Namilumab 20 mg/mL	Namilumab 80 mg/mL	Namilumab 150 mg/mL
Arm/Group Description:	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
Description	ACRn is defined as the lowest % improvement for TJC68, SJC66 and the m...
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

Outcome Measure Data

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
Arm/Group Description:	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
Description	The DAS28-CRP score is a measure of the participant's disease activity...
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

Outcome Measure Data

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
Arm/Group Description:		Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
Change at Week 2		-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
Change at Week 6		-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
Change at Week 10		-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
Description	The DAS28-CRP score is a measure of the participant's disease activity...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	Namilumab 20 mg/mL	Namilumab 80 mg/mL	Namilumab 150 mg/mL
Arm/Group Description:	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
Description	Reduction of Pain, defined as a ≥40% change from Baseline as mea...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Placebo	Namilumab 20 mg/mL	Namilumab 80 mg/mL	Namilumab 150 mg/mL
Arm/Group Description:		Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...
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
Week 2		7.7	14.3	8.7	3.6
Week 12	Number Analyzed	24 participants	25 participants	23 participants	26 participants
Week 12		20.8	44.0	39.1	30.8
Week 24	Number Analyzed	22 participants	23 participants	23 participants	25 participants
Week 24		22.7	43.5	47.8	24.0

Adverse Events

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
Arm/Group Description	Namilumab placebo-matching, SC inje...	Namilumab 20 mg/mL, subcutaneous (S...	Namilumab 80 mg/mL, SC injection, o...	Namilumab 150 mg/mL, SC injection, ...	Namilumab placebo-matching, SC inje...	Namilumab 20 or 80 mg/mL, SC inject...
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	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor PC, Saurigny D, Vencovsky J, Takeuchi T, Nakamura T, Matsievskaia G, Hunt B, Wagner T, Souberbielle B; NEXUS Study Group. Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial. Arthritis Res Ther. 2019 Apr 18;21(1):101. doi: 10.1186/s13075-019-1879-x.

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

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