Download PDF

Clinical Trial Results:
A Randomized, Double-blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Summary
EudraCT number	2014-004704-29
Trial protocol	CZ ES HU DE BG PL
Global end of trial date	13 Aug 2018

Results information
Results version number	v1(current)
This version publication date	24 Aug 2019
First version publication date	24 Aug 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

20140111

ISRCTN number

US NCT number

NCT02937701

WHO universal trial number (UTN)

Sponsor organisation name

Amgen Inc.

Sponsor organisation address

One Amgen Center Drive, Thousand Oaks, CA, United States, 91320

Public contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com

Scientific contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

13 Aug 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Aug 2018

Was the trial ended prematurely?

Main objective of the trial

The primary objective was to assess the efficacy of ABP 710 compared with US-licensed infliximab.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonisation (ICH) regulations and guidelines regarding Good Clinical Practice (GCP), clinical safety data management, and scientific integrity; with United States (US) Food and Drug Administration (FDA) regulations set forth in 21 Code of Federal Regulations Parts 50, 56, and 312; and with European Union (EU) Community Directives 2001/20, 2001/83, 2003/94, and 2005/28 as enacted into local law. Prior to initiation at each study center, the study protocol was reviewed by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC). All subjects were to provide written informed consent prior to entering the study and before initiation of any study-related procedure (including administration of investigational product). The investigator was responsible for explaining the benefits and risks of participation in the study to each subject or the subject’s legally acceptable representative and for obtaining written informed consent.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Oct 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 258

Country: Number of subjects enrolled

Czech Republic: 101

Country: Number of subjects enrolled

Germany: 26

Country: Number of subjects enrolled

Bulgaria: 25

Country: Number of subjects enrolled

Hungary: 21

Country: Number of subjects enrolled

Spain: 11

Country: Number of subjects enrolled

United States: 104

Country: Number of subjects enrolled

Canada: 3

Country: Number of subjects enrolled

Australia: 9

Worldwide total number of subjects

558

EEA total number of subjects

442

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

434

From 65 to 84 years

124

85 years and over

Subject disposition

Top of page

Recruitment details

This study was conducted at 75 centers in Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Spain, and the United States.

Screening 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.

Period 1 title

Day 1 to Week 22

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Assessor, Subject

Are arms mutually exclusive

Yes

ABP 710

Arm 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.

Arm type

Experimental

Investigational medicinal product name

ABP 710

Investigational medicinal product code

ABP 710

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

3-mg/kg IV infusion on day 1 (week 0), at weeks 2 and 6, and every 8 weeks thereafter.

Infliximab

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Infliximab

Investigational medicinal product code

Other name

Remicade®

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

3-mg/kg IV infusion on day 1 (week 0), at weeks 2 and 6, and every 8 weeks thereafter.

Number of subjects in period 1	ABP 710	Infliximab
Started	279	279
Received Treatment	278	278
Completed	244	240
Not completed	35	39
Adverse event, serious fatal	1	1
Consent withdrawn by subject	6	6
Physician decision	2	-
Dissatisfied with Treatment Efficacy	5	9
Adverse event, non-fatal	11	14
Other	1	-
Protocol Specified Criteria	7	7
Lost to follow-up	1	1
Protocol deviation	1	1

Period 2 title

Week 22 to Week 50

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

ABP 710 / ABP 710

Arm description

At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

Arm type

Experimental

Investigational medicinal product name

ABP 710

Investigational medicinal product code

ABP 710

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

3-mg/kg IV infusion administered every 8 weeks

Infliximab / Infliximab

Arm description

At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Arm type

Active comparator

Investigational medicinal product name

Infliximab

Investigational medicinal product code

Other name

Remicade®

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

3-mg/kg IV infusion administered every 8 weeks

Infliximab / ABP 710

Arm description

At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.

Arm type

Experimental

Investigational medicinal product name

ABP 710

Investigational medicinal product code

ABP 710

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

3-mg/kg IV infusion administered every 8 weeks

Number of subjects in period 2	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Started	244	121	119
Completed	212	113	110
Not completed	32	8	9
Consent withdrawn by subject	8	2	1
Physician decision	2	-	1
Dissatisfied with Treatment Efficacy	10	3	2
Adverse event, non-fatal	10	3	3
Other	-	-	1
Lost to follow-up	2	-	1

Baseline characteristics

Top of page

Reporting group title

ABP 710

Reporting 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.

Reporting group title

Infliximab

Reporting group description

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.

Reporting group values	ABP 710	Infliximab	Total
Number of subjects	279	279	558
Age, Customized
Units: Subjects
< 65 years	217	217	434
≥ 65 years	62	62	124
Age Continuous
Units: years
arithmetic mean (standard deviation)	55.0 ( 11.72 )	54.8 ( 11.42 )	-
Sex: Female, Male
Units: Subjects
Female	214	223	437
Male	65	56	121
Race/Ethnicity, Customized
Units: Subjects
White	265	267	532
Black or African American	12	12	24
Asian	2	0	2
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	18	13	31
Not Hispanic or Latino	261	266	527
Unknown or Not Reported	0	0	0
Geographic Region
Units: Subjects
Asia Pacific	5	4	9
Europe	220	222	442
North America	54	53	107
Prior Biologic Use for Rheumatoid Arthritis
Units: Subjects
Yes	77	81	158
No	202	198	400
Duration of Rheumatoid Arthritis (RA)
Units: years
arithmetic mean (standard deviation)	8.72 ( 7.914 )	8.34 ( 7.604 )	-
Swollen joint Count
A total of 66 joints were scored for presence or absence of swelling.
Units: joints
arithmetic mean (standard deviation)	14.595 ( 8.0507 )	14.730 ( 8.8315 )	-
Tender Joint Count
A total of 68 joints were scored for presence or absence of tenderness.
Units: joints
arithmetic mean (standard deviation)	23.109 ( 12.1648 )	23.764 ( 13.3800 )	-
Patient Global Health Assessment
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.
Units: mm
arithmetic mean (standard deviation)	65.4 ( 18.13 )	64.1 ( 20.03 )	-
Investigator's Global Health Assessment
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).
Units: mm
arithmetic mean (standard deviation)	64.5 ( 15.88 )	64.1 ( 15.76 )	-
Patient's Assessment of Disease-related Pain
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.
Units: mm
arithmetic mean (standard deviation)	63.5 ( 20.30 )	61.5 ( 21.65 )	-
Disability Index of the Health Assessment Questionnaire (HAQ-DI)
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.
Units: units on a scale
arithmetic mean (standard deviation)	1.44 ( 0.584 )	1.42 ( 0.617 )	-
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a protein found in blood. CRP levels rise in response to inflammation.
Units: mg/L
arithmetic mean (standard deviation)	14.26 ( 20.171 )	14.64 ( 23.117 )	-

End points

Top of page

Reporting group title

ABP 710

Reporting 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.

Reporting group title

Infliximab

Reporting group description

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.

Reporting group title

ABP 710 / ABP 710

Reporting group description

At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

Reporting group title

Infliximab / Infliximab

Reporting group description

At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Reporting group title

Infliximab / ABP 710

Reporting group description

At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

Top of page

End point title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

End point 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. The analysis was conducted in the intent-to-treat population which consisted of all randomized participants. Participants with missing data were counted as non-responders (non-responder imputation).

End point type

Primary

End point timeframe

Baseline and week 22

End point values	ABP 710	Infliximab
Number of subjects analysed	279	279
Units: percentage of participants
number (confidence interval 95%)	68.1 (62.63 to 73.57)	59.1 (53.37 to 64.91)

Primary Analysis of ACR20 at Week 22

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

equivalence ^[1]

Method

Parameter type

Response Difference

Point estimate

9.37

Confidence interval

level

90%

sides

2-sided

lower limit

2.67

upper limit

15.96

Notes
[1] - 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%).

Sensitivity Analysis of ACR20 at Week 22

Statistical analysis description

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.

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

equivalence ^[2]

Method

Parameter type

Response Difference

Point estimate

9.3

Confidence interval

level

90%

sides

2-sided

lower limit

2.67

upper limit

15.92

Notes
[2] - 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%).

Post-hoc Analysis of ACR20 at Week 22

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

equivalence ^[3]

Method

Parameter type

Response Difference

Point estimate

7.184

Confidence interval

level

90%

sides

2-sided

lower limit

0.748

upper limit

13.62

Notes
[3] - 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%).

Secondary: Percentage of Participants With an ACR20 Response Through Week 14

Top of page

End point title

Percentage of Participants With an ACR20 Response Through Week 14

End point 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. The analysis was conducted using the intent-to-treat population; participants with missing data at a given time point were counted as non-responders.

End point type

Secondary

End point timeframe

Baseline and weeks 2, 6, and 14

End point values	ABP 710	Infliximab
Number of subjects analysed	279	279
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 2

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

8.03

Confidence interval

level

90%

sides

2-sided

lower limit

1.15

upper limit

14.81

Response Difference at Week 14

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Response Difference

Point estimate

9.37

Confidence interval

level

90%

sides

2-sided

lower limit

-0.51

upper limit

12.87

Response Difference at Week 6

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

4.96

Confidence interval

level

90%

sides

2-sided

lower limit

-1.8

upper limit

11.64

Secondary: Percentage of Participants With an ACR20 Response After Week 22

Top of page

End point title

Percentage of Participants With an ACR20 Response After Week 22

End point 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. The analysis was conducted in 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.

End point type

Secondary

End point timeframe

Baseline and weeks 30, 34, 38, 46, and 50

End point values	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Number of subjects analysed	244	121	119
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 30

Statistical analysis description

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).

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

3.05

Confidence interval

level

90%

sides

2-sided

lower limit

-5.26

upper limit

11.73

Response Difference at Week 30

Statistical analysis description

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).

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.18

upper limit

17.97

Response Difference at Week 34

Statistical analysis description

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).

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

3.31

Confidence interval

level

90%

sides

2-sided

lower limit

-4.61

upper limit

11.7

Response Difference at Week 34

Statistical analysis description

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).

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

4.06

Confidence interval

level

90%

sides

2-sided

lower limit

-5.4

upper limit

13.4

Response Difference at Week 38

Statistical analysis description

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).

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

0.82

Confidence interval

level

90%

sides

2-sided

lower limit

-7.34

upper limit

9.4

Response Difference at Week 38

Statistical analysis description

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).

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

2.79

Confidence interval

level

90%

sides

2-sided

lower limit

-6.86

upper limit

12.34

Response Difference at Week 46

Statistical analysis description

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).

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-3.74

Confidence interval

level

90%

sides

2-sided

lower limit

-12.27

upper limit

5.17

Response Difference at Week 46

Statistical analysis description

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).

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

1.12

Confidence interval

level

90%

sides

2-sided

lower limit

-8.89

upper limit

11.08

Response Difference at Week 50

Statistical analysis description

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).

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Response Difference

Point estimate

-5.25

Confidence interval

level

90%

sides

2-sided

lower limit

-13.24

upper limit

3.29

Response Difference at Week 50

Statistical analysis description

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).

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-1.49

Confidence interval

level

90%

sides

2-sided

lower limit

-11.01

upper limit

8.04

Secondary: Percentage of Participants With an ACR50 Response Through Week 22

Top of page

End point title

Percentage of Participants With an ACR50 Response Through Week 22

End point 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. The analysis was conducted in the intent-to-treat population; participants with missing data at a given time point were counted as non-responders.

End point type

Secondary

End point timeframe

Baseline and weeks 2, 6, 14, and 22

End point values	ABP 710	Infliximab
Number of subjects analysed	279	279
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 2

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

4.41

Confidence interval

level

90%

sides

2-sided

lower limit

-0.56

upper limit

9.38

Response Difference at Week 6

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

1.62

Confidence interval

level

90%

sides

2-sided

lower limit

-4.71

upper limit

7.94

Response Difference at Week 14

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

2.3

Confidence interval

level

90%

sides

2-sided

lower limit

-4.45

upper limit

9.03

Response Difference at Week 22

Statistical analysis description

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).

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

7.09

Confidence interval

level

90%

sides

2-sided

lower limit

0.27

upper limit

13.83

Secondary: Percentage of Participants With an ACR50 Response After Week 22

Top of page

End point title

Percentage of Participants With an ACR50 Response After Week 22

End point 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. The analysis was conducted in 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.

End point type

Secondary

End point timeframe

Baseline and weeks 30, 34, 38, 46, and 50

End point values	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Number of subjects analysed	244	121	119
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 30

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-1.33

Confidence interval

level

90%

sides

2-sided

lower limit

-10.4

upper limit

7.62

Response Difference at Week 30

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

3.24

Confidence interval

level

90%

sides

2-sided

lower limit

-7.28

upper limit

13.67

Response Difference at Week 34

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

6.52

Confidence interval

level

90%

sides

2-sided

lower limit

-2.62

upper limit

15.48

Response Difference at Week 34

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

10.74

Confidence interval

level

90%

sides

2-sided

lower limit

0.12

upper limit

21.03

Response Difference at Week 38

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

0.56

Confidence interval

level

90%

sides

2-sided

lower limit

-8.54

upper limit

9.59

Response Difference at Week 38

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

2.93

Confidence interval

level

90%

sides

2-sided

lower limit

-7.62

upper limit

13.39

Response Difference at Week 46

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-1.04

Confidence interval

level

90%

sides

2-sided

lower limit

-10.11

upper limit

7.93

Response Difference at Week 46

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

6.14

Confidence interval

level

90%

sides

2-sided

lower limit

-4.44

upper limit

16.54

Response Difference at Week 50

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-5.43

Confidence interval

level

90%

sides

2-sided

lower limit

-14.39

upper limit

3.71

Response Difference at Week 50

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

2.98

Confidence interval

level

90%

sides

2-sided

lower limit

-7.51

upper limit

13.37

Secondary: Percentage of Participants With an ACR70 Response Through Week 22

Top of page

End point title

Percentage of Participants With an ACR70 Response Through Week 22

End point 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. The analysis was conducted in the intent-to-treat population; participants with missing data at a given visit were counted as non-responders.

End point type

Secondary

End point timeframe

Baseline and weeks 2, 6, 14, and 22

End point values	ABP 710	Infliximab
Number of subjects analysed	279	279
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 2

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-2.5

Confidence interval

level

90%

sides

2-sided

lower limit

-5.84

upper limit

0.83

Response Difference at Week 6

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-2.43

Confidence interval

level

90%

sides

2-sided

lower limit

-7.47

upper limit

2.64

Response Difference at Week 14

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

5.46

Confidence interval

level

90%

sides

2-sided

lower limit

-0.01

upper limit

10.91

Response Difference at Week 22

Statistical analysis description

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

4.58

Confidence interval

level

90%

sides

2-sided

lower limit

-1.21

upper limit

10.34

Secondary: Percentage of Participants With an ACR70 Response After Week 22

Top of page

End point title

Percentage of Participants With an ACR70 Response After Week 22

End point 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. The analysis was conducted in 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.

End point type

Secondary

End point timeframe

Baseline and weeks 30, 34, 38, 46, and 50

End point values	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Number of subjects analysed	244	121	119
Units: percentage of participants
number (confidence interval 95%)
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)

Response Difference at Week 30

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8.12

upper limit

8.02

Response Difference at Week 30

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-0.08

Confidence interval

level

90%

sides

2-sided

lower limit

-9.39

upper limit

9.28

Response Difference at Week 34

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

1.5

Confidence interval

level

90%

sides

2-sided

lower limit

-7

upper limit

9.51

Response Difference at Week 34

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

7.49

Confidence interval

level

90%

sides

2-sided

lower limit

-2.39

upper limit

17.22

Response Difference at Week 38

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-9.03

upper limit

7.59

Response Difference at Week 38

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

3.39

Confidence interval

level

90%

sides

2-sided

lower limit

-6.41

upper limit

13.14

Response Difference at Week 46

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

-0.43

Confidence interval

level

90%

sides

2-sided

lower limit

-8.98

upper limit

7.66

Response Difference at Week 46

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

7.87

Confidence interval

level

90%

sides

2-sided

lower limit

-2.13

upper limit

17.68

Response Difference at Week 50

Statistical analysis description

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

1.95

Confidence interval

level

90%

sides

2-sided

lower limit

-6.81

upper limit

10.29

Response Difference at Week 50

Statistical analysis description

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Response Difference

Point estimate

12.06

Confidence interval

level

90%

sides

2-sided

lower limit

1.74

upper limit

22.04

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

Top of page

End point title

Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

End point 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. The analysis was conducted in the intent-to-treat population with available data at each time point.

End point type

Secondary

End point timeframe

Baseline and weeks 2, 6, 14, and 22

End point values	ABP 710	Infliximab
Number of subjects analysed	279	279
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (N = 260, 255)	-1.36 ( 0.991 )	-1.29 ( 1.006 )
Week 6 (N = 259,253)	-1.82 ( 1.222 )	-1.82 ( 1.203 )
Week 14 (N = 253, 250)	-1.95 ( 1.218 )	-1.91 ( 1.289 )
Week 22 (N = 245, 243)	-2.06 ( 1.290 )	-2.06 ( 1.296 )

Mean Difference at Week 2

Statistical analysis description

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.

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.07

Confidence interval

level

90%

sides

2-sided

lower limit

-0.2

upper limit

0.007

Mean Difference at Week 6

Statistical analysis description

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.

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.17

upper limit

0.16

Mean Difference at Week 14

Statistical analysis description

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.

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.04

Confidence interval

level

90%

sides

2-sided

lower limit

-0.21

upper limit

0.14

Mean Difference at Week 22

Statistical analysis description

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.

Comparison groups

ABP 710 v Infliximab

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.01

Confidence interval

level

90%

sides

2-sided

lower limit

-0.2

upper limit

0.17

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

Top of page

End point title

Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

End point 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. The analysis was conducted in participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22) with available data.

End point type

Secondary

End point timeframe

Baseline and weeks 30, 34, 38, 46, and 50

End point values	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Number of subjects analysed	244	121	119
Units: units on a scale
arithmetic mean (standard deviation)
Week 30 (N = 225, 112, 112)	-2.07 ( 1.278 )	-2.25 ( 1.379 )	-2.22 ( 1.266 )
Week 34 (N = 222, 113, 111)	-2.32 ( 1.306 )	-2.46 ( 1.372 )	-2.45 ( 1.309 )
Week 38 (N = 219, 114, 110)	-2.20 ( 1.277 )	-2.27 ( 1.301 )	-2.32 ( 1.400 )
Week 46 (N = 205, 108, 108)	-2.11 ( 1.381 )	-2.27 ( 1.387 )	-2.26 ( 1.440 )
Week 50 (N = 203, 110, 107)	-2.45 ( 1.365 )	-2.49 ( 1.276 )	-2.64 ( 1.328 )

Mean Difference at Week 30

Statistical analysis description

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.

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

0.16

Confidence interval

level

90%

sides

2-sided

lower limit

-0.08

upper limit

0.4

Mean Difference at Week 30

Statistical analysis description

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.

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.27

upper limit

0.28

Mean Difference at Week 34

Statistical analysis description

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.

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

0.11

Confidence interval

level

90%

sides

2-sided

lower limit

-0.12

upper limit

0.35

Mean Difference at Week 34

Statistical analysis description

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.

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.03

Confidence interval

level

90%

sides

2-sided

lower limit

-0.3

upper limit

0.24

Mean Difference at Week 38

Statistical analysis description

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.

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

0.06

Confidence interval

level

90%

sides

2-sided

lower limit

-0.18

upper limit

0.3

Mean Difference at Week 38

Statistical analysis description

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.

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.08

Confidence interval

level

90%

sides

2-sided

lower limit

-0.36

upper limit

0.2

Mean Difference at Week 46

Statistical analysis description

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.

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

0.11

Confidence interval

level

90%

sides

2-sided

lower limit

-0.14

upper limit

0.37

Mean Difference at Week 46

Statistical analysis description

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.

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.05

Confidence interval

level

90%

sides

2-sided

lower limit

-0.34

upper limit

0.25

Mean Difference at Week 50

Statistical analysis description

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.

Comparison groups

ABP 710 / ABP 710 v Infliximab / Infliximab

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.24

upper limit

0.24

Mean Difference at Week 50

Statistical analysis description

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.

Comparison groups

Infliximab / Infliximab v Infliximab / ABP 710

Number of subjects included in analysis

240

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Mean Difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.47

upper limit

0.08

Adverse events

Top of page

Timeframe for reporting adverse events

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.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

ABP 710

Reporting 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.

Reporting group title

Infliximab

Reporting group description

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.

Reporting group title

ABP 710 / ABP 710

Reporting group description

At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

Reporting group title

Infliximab / Infliximab

Reporting group description

At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Reporting group title

Infliximab / ABP 710

Reporting group description

At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.

Serious adverse events	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Total subjects affected by serious adverse events
subjects affected / exposed	9 / 278 (3.24%)	14 / 278 (5.04%)	15 / 241 (6.22%)	4 / 121 (3.31%)	1 / 119 (0.84%)
number of deaths (all causes)	1	1	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian low malignant potential tumour
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Orthostatic hypotension
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	0 / 278 (0.00%)	2 / 278 (0.72%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	1 / 121 (0.83%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Transaminases increased
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femoral neck fracture
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Laceration
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Sciatica
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	1 / 119 (0.84%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	1 / 121 (0.83%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Jaundice cholestatic
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	1 / 121 (0.83%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	1 / 121 (0.83%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	1 / 121 (0.83%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	2 / 241 (0.83%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	1 / 119 (0.84%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	2 / 241 (0.83%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 278 (0.36%)	0 / 278 (0.00%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 278 (0.00%)	1 / 278 (0.36%)	0 / 241 (0.00%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 278 (0.00%)	0 / 278 (0.00%)	1 / 241 (0.41%)	0 / 121 (0.00%)	0 / 119 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	ABP 710	Infliximab	ABP 710 / ABP 710	Infliximab / Infliximab	Infliximab / ABP 710
Total subjects affected by non serious adverse events
subjects affected / exposed	48 / 278 (17.27%)	32 / 278 (11.51%)	52 / 241 (21.58%)	28 / 121 (23.14%)	30 / 119 (25.21%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
subjects affected / exposed	14 / 278 (5.04%)	11 / 278 (3.96%)	23 / 241 (9.54%)	9 / 121 (7.44%)	7 / 119 (5.88%)
occurrences all number	14	11	23	10	9
Infections and infestations
Nasopharyngitis
subjects affected / exposed	12 / 278 (4.32%)	4 / 278 (1.44%)	13 / 241 (5.39%)	11 / 121 (9.09%)	8 / 119 (6.72%)
occurrences all number	12	4	13	12	10
Pharyngitis
subjects affected / exposed	8 / 278 (2.88%)	3 / 278 (1.08%)	2 / 241 (0.83%)	2 / 121 (1.65%)	7 / 119 (5.88%)
occurrences all number	8	3	2	2	7
Upper respiratory tract infection
subjects affected / exposed	17 / 278 (6.12%)	18 / 278 (6.47%)	23 / 241 (9.54%)	9 / 121 (7.44%)	14 / 119 (11.76%)
occurrences all number	18	18	26	9	16

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

17 Mar 2017

- Clarified the premedication requirement. - Specified that subjects who were unable to complete the week 22 visit within the allowed window were to be discontinued from the study and that these subjects should return for an EOS visit to complete the EOS assessments within 28 days, if possible. - Specified that subjects who were unable to complete the screening procedures within 28 days before baseline would be considered screen failures. Specified that these subjects could be rescreened, and they may be rescreened under the same informed consent form if rescreening occurred within 30 days. - Removed "adverse events" from the list of examples of "Reasons for removal of a subject from the study." - Emphasized that preinfusion PK samples were required to be drawn within 1 hour before dosing and that end-of-infusion PK samples were required to be collected within 10 minutes of completing the infusion. - Specified that 95% CIs, in addition to 90% CIs, would be presented for efficacy endpoints. - Clarified the inclusion and exclusion criteria.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A Randomized, Double-blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

Secondary: Percentage of Participants With an ACR20 Response Through Week 14

Secondary: Percentage of Participants With an ACR20 Response Through Week 14

Secondary: Percentage of Participants With an ACR20 Response After Week 22

Secondary: Percentage of Participants With an ACR20 Response After Week 22

Secondary: Percentage of Participants With an ACR50 Response Through Week 22

Secondary: Percentage of Participants With an ACR50 Response Through Week 22

Secondary: Percentage of Participants With an ACR50 Response After Week 22

Secondary: Percentage of Participants With an ACR50 Response After Week 22

Secondary: Percentage of Participants With an ACR70 Response Through Week 22

Secondary: Percentage of Participants With an ACR70 Response Through Week 22

Secondary: Percentage of Participants With an ACR70 Response After Week 22

Secondary: Percentage of Participants With an ACR70 Response After Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Double-blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22

Secondary: Percentage of Participants With an ACR20 Response Through Week 14

Secondary: Percentage of Participants With an ACR20 Response Through Week 14

Secondary: Percentage of Participants With an ACR20 Response After Week 22

Secondary: Percentage of Participants With an ACR20 Response After Week 22

Secondary: Percentage of Participants With an ACR50 Response Through Week 22

Secondary: Percentage of Participants With an ACR50 Response Through Week 22

Secondary: Percentage of Participants With an ACR50 Response After Week 22

Secondary: Percentage of Participants With an ACR50 Response After Week 22

Secondary: Percentage of Participants With an ACR70 Response Through Week 22

Secondary: Percentage of Participants With an ACR70 Response Through Week 22

Secondary: Percentage of Participants With an ACR70 Response After Week 22

Secondary: Percentage of Participants With an ACR70 Response After Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) Through Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28) After Week 22

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis