Study to Assess if ABP710 is Safe & Effective in Treating... | NCT02937701

ID	Type	Description	Link
2014-004704-29	EudraCT Number

Label	Type	Description	Intervention Names
ABP 710	Experimental	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. At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	Biological: ABP 710
Infliximab	Active Comparator	Participants randomized to receive a 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 were re-randomized in a 1:1 ratio to either continue receiving 3 mg/kg infliximab every 8 weeks or transition to receive 3 mg/kg ABP 710 every 8 weeks through week 46.	Biological: Infliximab

Name	Type	Description	Arm Group Labels	Other Names
ABP 710	Biological	Administered by intravenous infusion	ABP 710

Measure	Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22	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.	Baseline and week 22

Measure	Description	Time Frame
Percentage of Participants With an ACR20 Response Through Week 14	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject (man or woman) is ≥ 18 and ≤ 80 years old.
Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA.
Subject has RA duration of at least 3 months.
Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least 1 of the following at screening:
- erythrocyte sedimentation rate ≥ 28 mm/hr
- serum C-reactive protein > 1.0 mg/dL
Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening.
Subject has taken methotrexate (MTX) for ≥ 12 consecutive weeks and is on a stable dose of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving the investigational product and is willing to remain on a stable dose throughout the study.
For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be stable for ≥ 2 weeks before screening.
For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the dose should be stable for ≥ 4 weeks before screening.
Subject has no known history of active tuberculosis.
Subject has a negative test for tuberculosis during screening defined as either:
- negative purified protein derivative (PPD) defined as < 5 mm of induration at 48 to 72 hours after test is placed OR
- negative Quantiferon test
Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test.
Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following:
- no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc.
- documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations
- no known exposure to a case of active tuberculosis after most recent prophylaxis

Exclusion Criteria:

Subject has a history of prosthetic or native joint infection.
Subject has an active infection or history of infections as follows:
- any active infection for which systemic anti-infectives were used within 28 days before first dose of investigational product
- a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infective(s) within 8 weeks before the first dose of investigational product
- recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject
Subject has a positive blood test for human immunodeficiency virus (HIV).
Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening.
Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate or severe heart failure (New York Heart Association Class III/IV), renal disease, liver disease, or hypertension.
Subject had a malignancy within 5 years EXCEPT for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma.
Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease.
Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome.
Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Subject has laboratory abnormalities at screening, including any of the following:
- hemoglobin < 9 g/dL
- platelet count < 100 000/mm³
- white blood cell count < 3 000/mm³
- aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 x the upper limit of normal
- creatinine clearance < 50 mL/min (Cockroft-Gault formula)
- any other laboratory abnormality, that, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
Subject has used commercially available or investigational biologic therapies for RA as follows:
- anakinra, etanercept within 1 month before the first dose of investigational product
- abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 3 months before the first dose of investigational product
- other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) before the first dose of investigational product
- rituximab within 9 months before the investigational product along with evidence of incomplete B cell recovery
Subject has received live vaccines within 28 days before the first dose of investigational product or plans to receive live vaccines during the course of the study.
Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab.
Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in the study and for 6 months after the last dose of investigational product.
Women of childbearing potential (ie, neither surgically sterile nor postmenopausal) and do not agree to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera® [medroxyprogesterone] injections, or contraceptive implants) while on study and for 6 months after the last dose of investigational product.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntsville	Alabama	35801	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
32216829	Derived	Genovese MC, Sanchez-Burson J, Oh M, Balazs E, Neal J, Everding A, Hala T, Wojciechowski R, Fanjiang G, Cohen S. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 Mar 26;22(1):60. doi: 10.1186/s13075-020-2142-1.

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	ABP 710	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.
FG001	Infliximab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 17, 2017	Aug 8, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00068.1(62.63 to 73.57) OG00159.1(53.37 to 64.91)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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).					Response Difference	9.37			2-Sided	90	2.67	15.96					Equivalence	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

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and weeks 2, 6, and 14

ID	Title	Description
OG000	ABP 710	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.
OG001	Infliximab	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.

Secondary

Percentage of Participants With an ACR20 Response After 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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	ABP 710 / ABP 710	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
OG001	Infliximab / Infliximab	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Secondary

Percentage of Participants With an ACR50 Response Through Week 22

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and weeks 2, 6, 14, and 22

ID	Title	Description
OG000	ABP 710	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.
OG001	Infliximab	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.

Secondary

Percentage of Participants With an ACR50 Response After Week 22

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.

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	ABP 710 / ABP 710	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
OG001	Infliximab / Infliximab	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Secondary

Percentage of Participants With an ACR70 Response Through Week 22

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and weeks 2, 6, 14, and 22

ID	Title	Description
OG000	ABP 710	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.
OG001	Infliximab	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.

Secondary

Percentage of Participants With an ACR70 Response After Week 22

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.

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	ABP 710 / ABP 710	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
OG001	Infliximab / Infliximab	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.

Secondary

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

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.

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

Posted

Mean

Standard Deviation

units on a scale

Baseline and weeks 2, 6, 14, and 22

ID	Title	Description
OG000	ABP 710	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.
OG001	Infliximab	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.

Secondary

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

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.

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.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	ABP 710 / ABP 710	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
OG001	Infliximab / Infliximab	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.
OG002

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG0030 affected121 at risk EG004
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Chest discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0022 affected241 at risk EG003
Febrile infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Transaminases increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0022 affected241 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Ovarian low malignant potential tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0020 affected241 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0011 affected278 at risk EG0020 affected241 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0010 affected278 at risk EG0021 affected241 at risk EG003
Thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected278 at risk EG0012 affected278 at risk EG0020 affected241 at risk EG003

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	ABP 710	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.
BG001	Infliximab	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABP 710	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.	1	278	9	278	48	278
EG001	Infliximab	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.	1	278	14	278	32	278
EG002	ABP 710 / ABP 710	At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.	0	241	15	241	52	241
EG003	Infliximab / Infliximab	At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.	0	121	4	121	28	121
EG004	Infliximab / ABP 710	At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.	0	119	1	119	30	119

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00012 affected278 at risk EG0014 affected278 at risk EG00213 affected241 at risk EG00311 affected121 at risk EG0048 affected119 at risk
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0008 affected278 at risk EG0013 affected278 at risk EG0022 affected241 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00017 affected278 at risk EG00118 affected278 at risk EG00223 affected241 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG00014 affected278 at risk EG00111 affected278 at risk EG00223 affected241 at risk EG003