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Trial record 1 of 3 for:    ABP710 | Amgen [Exact]
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Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937701
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
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
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
Hide 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
Arm/Group Title ABP 710 Infliximab Total
Hide 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
Hide 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.
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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.
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at each time point.
Arm/Group Title ABP 710 Infliximab
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
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Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
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
Hide 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%) 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
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