Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

• ClinicalTrials.gov Identifier: NCT02937701
• Recruitment Status: Completed
• First Posted: October 19, 2016
• Results First Posted: August 28, 2019
• Last Update Posted: August 28, 2019
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid
• Interventions: Biological: ABP 710; Biological: Infliximab
• Enrollment: 558

Participant Flow

Recruitment Details	This study was conducted at 75 centers in Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Spain, and the United States.
Pre-assignment Details	Participants were randomized in a 1:1 ratio to receive ABP 710 or infliximab, stratified by geographic region and prior biologic use. At week 22 participants initially randomized to infliximab were re-randomized in a 1:1 ratio to continue infliximab or switch to ABP 710. Participants initially randomized to ABP 710 continued receiving ABP 710.

Arm/Group Title	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description	Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
Period Title: Day 1 to Week 22
Started	279	279	0	0	0
Received Treatment	278	278	0	0	0
Completed	244	240	0	0	0
Not Completed	35	39	0	0	0
Reason Not Completed
Adverse Event	11	14	0	0	0
Protocol Specified Criteria	7	7	0	0	0
Dissatisfied With Treatment Efficacy	5	9	0	0	0
Withdrawal by Subject	6	6	0	0	0
Death	1	1	0	0	0
Protocol Violation	1	1	0	0	0
Lost to Follow-up	1	1	0	0	0
Physician Decision	2	0	0	0	0
Other	1	0	0	0	0
Period Title: Week 22 to Week 50
Started	0	0	244	121	119
Completed	0	0	212	113	110
Not Completed	0	0	32	8	9
Reason Not Completed
Adverse Event	0	0	10	3	3
Dissatisfied with Treatment Efficacy	0	0	10	3	2
Withdrawal by Subject	0	0	8	2	1
Lost to Follow-up	0	0	2	0	1
Physician Decision	0	0	2	0	1
Other	0	0	0	0	1

Baseline Characteristics

Arm/Group Title		ABP 710	Infliximab	Total
Arm/Group Description		Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Total of all reporting groups
Overall Number of Baseline Participants		279	279	558
Baseline Analysis Population Description		The intent-to-treat analysis set included all randomized participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	279 participants	279 participants	558 participants
		55.0 (11.72)	54.8 (11.42)	54.9 (11.56)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	< 65 years	217 77.8%	217 77.8%	434 77.8%
	≥ 65 years	62 22.2%	62 22.2%	124 22.2%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	Female	214 76.7%	223 79.9%	437 78.3%
	Male	65 23.3%	56 20.1%	121 21.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	Hispanic or Latino	18 6.5%	13 4.7%	31 5.6%
	Not Hispanic or Latino	261 93.5%	266 95.3%	527 94.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	White	265 95.0%	267 95.7%	532 95.3%
	Black or African American	12 4.3%	12 4.3%	24 4.3%
	Asian	2 0.7%	0 0.0%	2 0.4%
Geographic Region; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	Asia Pacific	5 1.8%	4 1.4%	9 1.6%
	Europe	220 78.9%	222 79.6%	442 79.2%
	North America	54 19.4%	53 19.0%	107 19.2%
Prior Biologic Use for Rheumatoid Arthritis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	279 participants	279 participants	558 participants
	Yes	77 27.6%	81 29.0%	158 28.3%
	No	202 72.4%	198 71.0%	400 71.7%
Duration of Rheumatoid Arthritis (RA); Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	279 participants	279 participants	558 participants
		8.72 (7.914)	8.34 (7.604)	8.53 (7.756)
Swollen joint Count [1]; Mean (Standard Deviation); Unit of measure: Joints
	Number Analyzed	279 participants	279 participants	558 participants
		14.595 (8.0507)	14.730 (8.8315)	14.663 (8.4428)
		[1] Measure Description: A total of 66 joints were scored for presence or absence of swelling.
Tender Joint Count [1]; Mean (Standard Deviation); Unit of measure: Joints
	Number Analyzed	279 participants	279 participants	558 participants
		23.109 (12.1648)	23.764 (13.3800)	23.436 (12.7796)
		[1] Measure Description: A total of 68 joints were scored for presence or absence of tenderness.
Patient Global Health Assessment [1] [2]; Mean (Standard Deviation); Unit of measure: Mm
	Number Analyzed	278 participants	278 participants	556 participants
		65.4 (18.13)	64.1 (20.03)	64.7 (19.10)
		[1] Measure Description: The participant's overall assessment of their disease activity in the past week assessed on a 100 mm visual analog scale (VAS), where 0 mm = No RA activity at all and 100 mm = Worst RA activity imaginable.; [2] Measure Analysis Population Description: Participants with available data
Investigator's Global Health Assessment [1] [2]; Mean (Standard Deviation); Unit of measure: Mm
	Number Analyzed	278 participants	278 participants	556 participants
		64.5 (15.88)	64.1 (15.76)	64.3 (15.81)
		[1] Measure Description: The investigator's assessment of the participant's current disease activity assessed on a 100 mm VAS where 0 mm = no activity at all (symptom-free and no arthritis symptoms) and 100 mm = worst activity imaginable (maximum arthritis disease activity).; [2] Measure Analysis Population Description: Participants with available data
Patient's Assessment of Disease-related Pain [1]; Mean (Standard Deviation); Unit of measure: Mm
	Number Analyzed	279 participants	279 participants	558 participants
		63.5 (20.30)	61.5 (21.65)	62.5 (20.99)
		[1] Measure Description: The participant's assessment of their current level of pain assessed on a 100 mm horizontal VAS, where 0 mm = no pain at all and 100 mm = worst pain imaginable.
Disability Index of the Health Assessment Questionnaire (HAQ-DI) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	278 participants	278 participants	556 participants
		1.44 (0.584)	1.42 (0.617)	1.43 (0.601)
		[1] Measure Description: The HAQ-DI is a patient-reported questionnaire consisting of 20 questions in eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.; [2] Measure Analysis Population Description: Participants with available data
C-reactive Protein (CRP) Concentration [1]; Mean (Standard Deviation); Unit of measure: mg/L
	Number Analyzed	279 participants	279 participants	558 participants
		14.26 (20.171)	14.64 (23.117)	14.45 (21.675)
		[1] Measure Description: C-reactive protein (CRP) is a protein found in blood. CRP levels rise in response to inflammation.

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
Description	The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22. A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 20% improvement in 68 tender joint count;; ≥ 20% improvement in 66 swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and week 22

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; Participants with missing data at week 22 were counted as non-responders

Arm/Group Title	ABP 710	Infliximab
Arm/Group Description:	Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
Overall Number of Participants Analyzed	279	279
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	68.1; (62.63 to 73.57)	59.1; (53.37 to 64.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).
	Type of Statistical Test	Equivalence
	Comments	Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	9.37
	Confidence Interval	(2-Sided) 90%; 2.67 to 15.96
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.
	Type of Statistical Test	Equivalence
	Comments	Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	9.30
	Confidence Interval	(2-Sided) 90%; 2.67 to 15.92
	Estimation Comments	Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).
	Type of Statistical Test	Equivalence
	Comments	Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	7.184
	Confidence Interval	(2-Sided) 90%; 0.748 to 13.620
	Estimation Comments	The ACR core set includes tender joint count, swollen joint count, subject’s global health assessment, investigator’s global health assessment, subject’s assessment of disease related pain, HAQ-DI, and CRP.

2. Secondary Outcome

Title	Percentage of Participants With an ACR20 Response Through Week 14
Description	A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 20% improvement in 68 tender joint count;; ≥ 20% improvement in 66 swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 2, 6, and 14

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710	Infliximab
Arm/Group Description:	Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
Overall Number of Participants Analyzed	279	279
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	46.2; (40.39 to 52.09)	38.0; (32.30 to 43.69)
Week 6	64.9; (59.27 to 70.48)	59.9; (54.10 to 65.61)
Week 14	66.3; (60.76 to 71.85)	60.2; (54.47 to 65.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	8.03
	Confidence Interval	(2-Sided) 90%; 1.15 to 14.81
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	4.96
	Confidence Interval	(2-Sided) 90%; -1.80 to 11.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	9.37
	Confidence Interval	(2-Sided) 90%; -0.51 to 12.87
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With an ACR20 Response After Week 22
Description	A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 20% improvement in 68 tender joint count;; ≥ 20% improvement in 66 swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 30, 34, 38, 46, and 50

Outcome Measure Data

Analysis Population Description

Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description:	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
Overall Number of Participants Analyzed	244	121	119
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 30	69.7; (63.90 to 75.44)	66.9; (58.56 to 75.32)	74.8; (66.99 to 82.59)
Week 34	74.6; (69.13 to 80.05)	71.1; (63.00 to 79.15)	74.8; (66.99 to 82.59)
Week 38	70.5; (64.77 to 76.21)	69.4; (61.21 to 77.63)	72.3; (64.23 to 80.31)
Week 46	61.9; (55.79 to 67.98)	65.3; (56.81 to 73.77)	66.4; (57.90 to 74.87)
Week 50	67.6; (61.75 to 73.49)	72.7; (64.79 to 80.66)	70.6; (62.40 to 78.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	3.05
	Confidence Interval	(2-Sided) 90%; -5.26 to 11.73
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	8.50
	Confidence Interval	(2-Sided) 90%; -1.18 to 17.97
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	3.31
	Confidence Interval	(2-Sided) 90%; -4.61 to 11.70
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	4.06
	Confidence Interval	(2-Sided) 90%; -5.40 to 13.40
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 90%; -7.34 to 9.40
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	2.79
	Confidence Interval	(2-Sided) 90%; -6.86 to 12.34
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-3.74
	Confidence Interval	(2-Sided) 90%; -12.27 to 5.17
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 90%; -8.89 to 11.08
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-5.25
	Confidence Interval	(2-Sided) 90%; -13.24 to 3.29
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-1.49
	Confidence Interval	(2-Sided) 90%; -11.01 to 8.04
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants With an ACR50 Response Through Week 22
Description	A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 50% improvement in 68 tender joint count;; ≥ 50% improvement in 66 swollen joint count; and; ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 2, 6, 14, and 22

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710	Infliximab
Arm/Group Description:	Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
Overall Number of Participants Analyzed	279	279
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	17.2; (12.78 to 21.63)	12.5; (8.66 to 16.43)
Week 6	30.1; (24.72 to 35.49)	28.3; (23.03 to 33.60)
Week 14	39.4; (33.69 to 45.16)	36.9; (31.25 to 42.58)
Week 22	43.0; (37.20 to 48.82)	36.2; (30.56 to 41.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	4.41
	Confidence Interval	(2-Sided) 90%; -0.56 to 9.38
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 90%; -4.71 to 7.94
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	2.30
	Confidence Interval	(2-Sided) 90%; -4.45 to 9.03
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	7.09
	Confidence Interval	(2-Sided) 90%; 0.27 to 13.83
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With an ACR50 Response After Week 22
Description	A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 50% improvement in 68 tender joint count;; ≥ 50% improvement in 66 swollen joint count; and; ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 30, 34, 38, 46, and 50

Outcome Measure Data

Analysis Population Description

Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description:	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
Overall Number of Participants Analyzed	244	121	119
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 30	43.0; (36.82 to 49.25)	44.6; (35.77 to 53.49)	47.1; (38.09 to 56.03)
Week 34	52.5; (46.19 to 58.73)	46.3; (37.40 to 55.17)	56.3; (47.39 to 65.21)
Week 38	48.0; (41.68 to 54.22)	47.1; (38.21 to 56.00)	49.6; (40.60 to 58.56)
Week 46	43.9; (37.63 to 50.08)	44.6; (35.77 to 53.49)	50.4; (41.44 to 59.40)
Week 50	49.2; (42.91 to 55.45)	54.5; (45.67 to 63.42)	57.1; (48.25 to 66.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-1.33
	Confidence Interval	(2-Sided) 90%; -10.40 to 7.62
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	3.24
	Confidence Interval	(2-Sided) 90%; -7.28 to 13.67
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	6.52
	Confidence Interval	(2-Sided) 90%; -2.62 to 15.48
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	10.74
	Confidence Interval	(2-Sided) 90%; 0.12 to 21.03
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 90%; -8.54 to 9.59
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	2.93
	Confidence Interval	(2-Sided) 90%; -7.62 to 13.39
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 90%; -10.11 to 7.93
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	6.14
	Confidence Interval	(2-Sided) 90%; -4.44 to 16.54
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-5.43
	Confidence Interval	(2-Sided) 90%; -14.39 to 3.71
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	2.98
	Confidence Interval	(2-Sided) 90%; -7.51 to 13.37
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants With an ACR70 Response Through Week 22
Description	A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 70% improvement in 68 tender joint count;; ≥ 70% improvement in 66 swollen joint count; and; ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 2, 6, 14, and 22

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710	Infliximab
Arm/Group Description:	Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
Overall Number of Participants Analyzed	279	279
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	3.9; (1.66 to 6.23)	6.5; (3.57 to 9.33)
Week 6	14.3; (10.22 to 18.45)	16.5; (12.13 to 20.84)
Week 14	21.9; (17.01 to 26.71)	16.1; (11.81 to 20.44)
Week 22	24.0; (19.00 to 29.03)	19.7; (15.05 to 24.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-2.50
	Confidence Interval	(2-Sided) 90%; -5.84 to 0.83
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-2.43
	Confidence Interval	(2-Sided) 90%; -7.47 to 2.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	5.46
	Confidence Interval	(2-Sided) 90%; -0.01 to 10.91
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	4.58
	Confidence Interval	(2-Sided) 90%; -1.21 to 10.34
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Percentage of Participants With an ACR70 Response After Week 22
Description	A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 70% improvement in 68 tender joint count;; ≥ 70% improvement in 66 swollen joint count; and; ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]); Patient's global health assessment (measured on a 100 mm VAS); Investigator's global health assessment (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein concentration.
Time Frame	Baseline and weeks 30, 34, 38, 46, and 50

Outcome Measure Data

Analysis Population Description

Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.

Arm/Group Title	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description:	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
Overall Number of Participants Analyzed	244	121	119
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 30	26.6; (21.09 to 32.19)	26.4; (18.59 to 34.30)	26.1; (18.16 to 33.94)
Week 34	29.5; (23.79 to 35.23)	28.1; (20.09 to 36.11)	35.3; (26.71 to 43.88)
Week 38	29.1; (23.40 to 34.80)	29.8; (21.61 to 37.90)	32.8; (24.34 to 41.21)
Week 46	29.5; (23.79 to 35.23)	29.8; (21.61 to 37.90)	37.0; (28.30 to 45.65)
Week 50	34.0; (28.07 to 39.96)	32.2; (23.90 to 40.56)	43.7; (34.79 to 52.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 90%; -8.12 to 8.02
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 90%; -9.39 to 9.28
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 90%; -7.00 to 9.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	7.49
	Confidence Interval	(2-Sided) 90%; -2.39 to 17.22
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 90%; -9.03 to 7.59
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	3.39
	Confidence Interval	(2-Sided) 90%; -6.41 to 13.14
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 90%; -8.98 to 7.66
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	7.87
	Confidence Interval	(2-Sided) 90%; -2.13 to 17.68
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	1.95
	Confidence Interval	(2-Sided) 90%; -6.81 to 10.29
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Difference
	Estimated Value	12.06
	Confidence Interval	(2-Sided) 90%; 1.74 to 22.04
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22
Description	The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count; 28 swollen joint count; C-reactive protein (CRP); Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Time Frame	Baseline and weeks 2, 6, 14, and 22

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data at each time point.

Arm/Group Title		ABP 710	Infliximab
Arm/Group Description:		Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
Overall Number of Participants Analyzed		279	279
Mean (Standard Deviation); Unit of Measure: units on a scale
Week 2	Number Analyzed	260 participants	255 participants
		-1.36 (0.991)	-1.29 (1.006)
Week 6	Number Analyzed	259 participants	253 participants
		-1.82 (1.222)	-1.82 (1.203)
Week 14	Number Analyzed	253 participants	250 participants
		-1.95 (1.218)	-1.91 (1.289)
Week 22	Number Analyzed	245 participants	243 participants
		-2.06 (1.290)	-2.06 (1.296)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 90%; -0.20 to 0.007
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.17 to 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 90%; -0.21 to 0.14
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ABP 710, Infliximab
	Comments	Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 90%; -0.20 to 0.17
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22
Description	The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count; 28 swollen joint count; C-reactive protein (CRP); Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Time Frame	Baseline and weeks 30, 34, 38, 46, and 50

Outcome Measure Data

Analysis Population Description

Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22) and with available data at each time point.

Arm/Group Title		ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description:		At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
Overall Number of Participants Analyzed		244	121	119
Mean (Standard Deviation); Unit of Measure: units on a scale
Week 30	Number Analyzed	225 participants	112 participants	112 participants
		-2.07 (1.278)	-2.25 (1.379)	-2.22 (1.266)
Week 34	Number Analyzed	222 participants	113 participants	111 participants
		-2.32 (1.306)	-2.46 (1.372)	-2.45 (1.309)
Week 38	Number Analyzed	219 participants	114 participants	110 participants
		-2.20 (1.277)	-2.27 (1.301)	-2.32 (1.400)
Week 46	Number Analyzed	205 participants	108 participants	108 participants
		-2.11 (1.381)	-2.27 (1.387)	-2.26 (1.440)
Week 50	Number Analyzed	203 participants	110 participants	107 participants
		-2.45 (1.365)	-2.49 (1.276)	-2.64 (1.328)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90%; -0.08 to 0.40
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.27 to 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.12 to 0.35
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90%; -0.30 to 0.24
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; -0.18 to 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 90%; -0.36 to 0.20
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.14 to 0.37
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90%; -0.34 to 0.25
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ABP 710 / ABP 710, Infliximab / Infliximab
	Comments	Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.24 to 0.24
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Infliximab / Infliximab, Infliximab / ABP 710
	Comments	Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 90%; -0.47 to 0.08
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From first dose to week 22 (initial ABP 710 and infliximab treatment groups) and from week 22 to week 50 for participants re-randomized at week 22, or up to 28 days after last dose for participants who discontinued early.
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Arm/Group Description	Participants received 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	Participants received 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
All-Cause Mortality
	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/278 (0.36%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Serious Adverse Events
	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	9/278 (3.24%)	14/278 (5.04%)	15/241 (6.22%)	4/121 (3.31%)	1/119 (0.84%)
Blood and lymphatic system disorders
Iron deficiency anaemia † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	1/119 (0.84%)
Microcytic anaemia † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Cardiac disorders
Acute myocardial infarction † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Cardiac failure congestive † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Cardiovascular insufficiency † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Myocardial infarction † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Ventricular extrasystoles † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Gastrointestinal disorders
Colitis † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Constipation † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Pancreatitis acute † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	1/121 (0.83%)	0/119 (0.00%)
General disorders
Chest discomfort † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Non-cardiac chest pain † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Hepatobiliary disorders
Jaundice cholestatic † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	1/121 (0.83%)	0/119 (0.00%)
Infections and infestations
Appendicitis † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Arthritis bacterial † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Cellulitis † 1	0/278 (0.00%)	0/278 (0.00%)	2/241 (0.83%)	0/121 (0.00%)	0/119 (0.00%)
Febrile infection † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Gastroenteritis † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Pneumonia bacterial † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Pneumonia legionella † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Pneumonia pneumococcal † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Pneumonia viral † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Injury, poisoning and procedural complications
Femoral neck fracture † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Hip fracture † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Laceration † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Multiple injuries † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Tibia fracture † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Investigations
Transaminases increased † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	1/121 (0.83%)	0/119 (0.00%)
Foot deformity † 1	0/278 (0.00%)	0/278 (0.00%)	2/241 (0.83%)	0/121 (0.00%)	0/119 (0.00%)
Muscular weakness † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Rheumatoid arthritis † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	1/119 (0.84%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Endometrial adenocarcinoma † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Malignant melanoma † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Ovarian low malignant potential tumour † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Transitional cell carcinoma † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Nervous system disorders
Sciatica † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Transient ischaemic attack † 1	1/278 (0.36%)	0/278 (0.00%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Renal and urinary disorders
Nephrolithiasis † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Renal failure † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Ureterolithiasis † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	1/121 (0.83%)	0/119 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis atopic † 1	0/278 (0.00%)	0/278 (0.00%)	0/241 (0.00%)	1/121 (0.83%)	0/119 (0.00%)
Vascular disorders
Orthostatic hypotension † 1	0/278 (0.00%)	1/278 (0.36%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
Peripheral ischaemia † 1	0/278 (0.00%)	0/278 (0.00%)	1/241 (0.41%)	0/121 (0.00%)	0/119 (0.00%)
Thrombosis † 1	0/278 (0.00%)	2/278 (0.72%)	0/241 (0.00%)	0/121 (0.00%)	0/119 (0.00%)
1 Term from vocabulary, MedDRA 20.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	48/278 (17.27%)	32/278 (11.51%)	52/241 (21.58%)	28/121 (23.14%)	30/119 (25.21%)
Infections and infestations
Nasopharyngitis † 1	12/278 (4.32%)	4/278 (1.44%)	13/241 (5.39%)	11/121 (9.09%)	8/119 (6.72%)
Pharyngitis † 1	8/278 (2.88%)	3/278 (1.08%)	2/241 (0.83%)	2/121 (1.65%)	7/119 (5.88%)
Upper respiratory tract infection † 1	17/278 (6.12%)	18/278 (6.47%)	23/241 (9.54%)	9/121 (7.44%)	14/119 (11.76%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis † 1	14/278 (5.04%)	11/278 (3.96%)	23/241 (9.54%)	9/121 (7.44%)	7/119 (5.88%)
1 Term from vocabulary, MedDRA 20.1; † Indicates events were collected by systematic assessment

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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

Results Point of Contact

• Name/Title: Study Director
• Organization: Amgen Inc.
• Phone: 866-572-6436
• EMail: medinfo@amgen.com

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

Genovese MC, Sanchez-Burson J, Oh M, Balazs E, Neal J, Everding A, Hala T, Wojciechowski R, Fanjiang G, Cohen S. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 Mar 26;22(1):60. doi: 10.1186/s13075-020-2142-1.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT02937701
• Other Study ID Numbers: 20140111; 2014-004704-29 ( EudraCT Number )
• First Submitted: August 30, 2016
• First Posted: October 19, 2016
• Results First Submitted: August 8, 2019
• Results First Posted: August 28, 2019
• Last Update Posted: August 28, 2019