A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

• ClinicalTrials.gov Identifier: NCT02222493
• Recruitment Status: Completed
• First Posted: August 21, 2014
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Biological: PF-06438179; Biological: Infliximab
• Enrollment: 650

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization.

Arm/Group Title	PF-06438179	Infliximab-EU Remicade (INX)
Arm/Group Description	Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
Period Title: Period 1: First Dose-Week 30 (Pre-dose)
Started	324	326
Received Treatment	323	326
Completed	280	286
Not Completed	44	40
Reason Not Completed
Death	2	2
Lost to Follow-up	0	1
Withdrawal by Subject	11	9
Protocol Violation	5	1
Insufficient clinical response	0	7
Non-compliance with study treatment	1	0
Pregnancy	2	0
Adverse Event	18	20
Other	4	0
Randomized but not treated	1	0
Period Title: Period 2: Week30 Dosing-Week54(Pre-dose)
Started	423	143
Completed	380	126
Not Completed	43	17
Reason Not Completed
Death	1	0
Adverse Event	22	9
Other	3	0
Non-compliance with study treatment	1	0
Withdrawal by Subject	6	4
Lost to Follow-up	1	1
Insufficient clinical response	9	3
Period Title: Period 3: Week 54 Dosing-Week 78 Visit
Started	505	0
Completed	474	0
Not Completed	31	0
Reason Not Completed
Insufficient clinical response	3	0
Adverse Event	14	0
Other	4	0
Non-compliance with study treatment	1	0
Withdrawal by Subject	9	0

Baseline Characteristics

Arm/Group Title		PF-06438179	Infliximab-EU Remicade (INX)	Total
Arm/Group Description		Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Total of all reporting groups
Overall Number of Baseline Participants		324	326	650
Baseline Analysis Population Description		The Intent-to-Treat (ITT) Population was defined as all participants who were randomized to study treatment.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	324 participants	326 participants	650 participants
		52.8 (13.3)	52.8 (12.9)	52.8 (13.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	324 participants	326 participants	650 participants
	Female	258 79.6%	264 81.0%	522 80.3%
	Male	66 20.4%	62 19.0%	128 19.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
Description	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).
Time Frame	Week 14

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	324	326
Measure Type: Number; Unit of Measure: participants
	198	207

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period 1: PF-06438179, Period 1: Infliximab-EU Remicade (INX)
	Comments	Score statistic method
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence test
Method of Estimation	Estimation Parameter	Proportion Difference
	Estimated Value	-2.39
	Confidence Interval	(2-Sided) 95%; -9.92 to 5.11
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Period 1: PF-06438179, Period 1: Infliximab-EU Remicade (INX)
	Comments	Score statistic method
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence test
Method of Estimation	Estimation Parameter	Proportion Difference
	Estimated Value	-2.39
	Confidence Interval	(2-Sided) 90%; -8.75 to 4.02
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Time Frame	Week 2, 4, 6, 12, 22 and 30 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	324	326
Measure Type: Number; Unit of Measure: participants
Week 2	105	121
Week 4	170	190
Week 6	187	201
Week 12	210	214
week 22	205	213
Week 30 (pre-dose)	197	209

3. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Time Frame	Week 38, 46 and 54 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	280	143	143
Measure Type: Number; Unit of Measure: participants
Week 38	206	101	110
Week 46	199	98	99
Week 54 (pre-dose)	199	92	101

4. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Time Frame	Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	253	126	126
Measure Type: Number; Unit of Measure: participants
Week 62	199	89	103
Week 70	199	87	98
Week 78	192	86	98

5. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1
Description	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Time Frame	Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	324	326
Measure Type: Number; Unit of Measure: participants
ACR50 (Week 2)	24	24
ACR50 (Week 4)	72	59
ACR50 (Week 6)	88	80
ACR50 (Week 12)	95	101
ACR50 (Week 14)	116	108
ACR50 (Week 22)	126	116
ACR50 (Week 30, pre-dose)	125	132
ACR70 (Week 2)	6	6
ACR70 (Week 4)	22	13
ACR70 (Week 6)	33	16
ACR70 (Week 12)	46	40
ACR70 (Week 14)	56	33
ACR70 (Week 22)	56	45
ACR70 (Week 30, pre-dose)	67	58

6. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2
Description	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Time Frame	Week 38, 46 and 54 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	280	143	143
Measure Type: Number; Unit of Measure: participants
ACR50 (Week 38)	132	58	75
ACR50 (Week 46)	135	55	63
ACR50 (Week 54, pre-dose)	135	61	65
ACR70 (Week 38)	77	33	38
ACR70 (Week 46)	75	33	33
ACR70 (Week 54, pre-dose)	82	33	35

7. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
Description	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Time Frame	Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	253	126	126
Measure Type: Number; Unit of Measure: participants
ACR50 (Week 62)	132	59	71
ACR50 (Week 70)	142	61	67
ACR50 (Week 78)	150	57	73
ACR70 (Week 62)	88	31	41
ACR70 (Week 70)	92	35	44
ACR70 (Week 78)	98	33	44

8. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Description	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		324	326
Mean (Standard Deviation); Unit of Measure: units on a scale
DAS28-CRP (Baseline)	Number Analyzed	321 participants	325 participants
		5.950 (0.9577)	5.983 (0.9210)
DAS28-CRP (Change at Week 2)	Number Analyzed	318 participants	324 participants
		-1.213 (0.9280)	-1.241 (0.8879)
DAS28-CRP (Change at Week 4)	Number Analyzed	312 participants	315 participants
		-1.596 (1.1259)	-1.605 (1.0881)
DAS28-CRP (Change at Week 6)	Number Analyzed	312 participants	319 participants
		-1.710 (1.1959)	-1.750 (1.0885)
DAS28-CRP (Change at Week 12)	Number Analyzed	310 participants	316 participants
		-1.898 (1.3516)	-1.885 (1.2142)
DAS28-CRP (Change at Week 14)	Number Analyzed	310 participants	314 participants
		-1.901 (1.4125)	-1.827 (1.3019)
DAS28-CRP (Change at Week 22)	Number Analyzed	301 participants	307 participants
		-2.005 (1.4236)	-2.002 (1.2972)
DAS28-CRP (Change at Week 30)	Number Analyzed	292 participants	297 participants
		-2.140 (1.4197)	-2.117 (1.2738)
HAQ-DI (Baseline)	Number Analyzed	321 participants	325 participants
		1.623 (0.6485)	1.586 (0.6490)
HAQ-DI (Change at Week 2)	Number Analyzed	320 participants	324 participants
		-0.317 (0.4100)	-0.328 (0.4370)
HAQ-DI (Change at Week 4)	Number Analyzed	317 participants	321 participants
		-0.472 (0.4728)	-0.477 (0.4861)
HAQ-DI (Change at Week 6)	Number Analyzed	314 participants	320 participants
		-0.496 (0.5505)	-0.520 (0.5022)
HAQ-DI (Change at Week 12)	Number Analyzed	311 participants	318 participants
		-0.535 (0.5795)	-0.524 (0.5857)
HAQ-DI (Change at Week 14)	Number Analyzed	311 participants	316 participants
		-0.572 (0.5910)	-0.531 (0.5876)
HAQ-DI (Change at Week 22)	Number Analyzed	301 participants	311 participants
		-0.588 (0.6061)	-0.569 (0.5958)
HAQ-DI (Change at Week 30)	Number Analyzed	294 participants	298 participants
		-0.621 (0.6484)	-0.612 (0.6546)

9. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
Description	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame	Baseline (Week 30 pre-dose), Week 38, 46 and 54

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		278	142	141
Mean (Standard Deviation); Unit of Measure: units on a scale
DAS28-CRP (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		3.765 (1.4629)	3.819 (1.3624)	3.781 (1.2547)
DAS28-CRP (Change at Week 38)	Number Analyzed	276 participants	141 participants	140 participants
		-0.181 (0.9574)	0.036 (0.8686)	-0.059 (0.8756)
DAS28-CRP (Change at Week 46)	Number Analyzed	266 participants	138 participants	133 participants
		-0.228 (1.0453)	0.048 (1.2584)	-0.017 (1.0692)
DAS28-CRP (Change at Week 54)	Number Analyzed	256 participants	129 participants	128 participants
		-0.275 (1.1338)	-0.109 (1.1801)	-0.057 (1.2339)
HAQ-DI (Change at Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		0.978 (0.7042)	0.913 (0.6634)	0.951 (0.6481)
HAQ-DI (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-0.019 (0.3328)	0.019 (0.2889)	0.007 (0.3688)
HAQ-DI (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-0.043 (0.3774)	0.014 (0.3823)	0.035 (0.4325)
HAQ-DI (Change at Week 54)	Number Analyzed	259 participants	130 participants	129 participants
		-0.026 (0.4407)	0.017 (0.4399)	-0.044 (0.3881)

10. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
Description	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame	Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		249	123	126
Mean (Standard Deviation); Unit of Measure: units on a scale
DAS28-CRP (Baseline)	Number Analyzed	249 participants	123 participants	124 participants
		3.386 (1.3229)	3.561 (1.3123)	3.594 (1.2572)
DAS28-CRP (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.072 (0.9150)	-0.004 (0.8190)	-0.154 (0.6840)
DAS28-CRP (Change at Week 70)	Number Analyzed	244 participants	119 participants	121 participants
		-0.157 (0.9502)	-0.168 (0.8421)	-0.162 (0.7970)
DAS28-CRP (Change at Week 78)	Number Analyzed	239 participants	114 participants	118 participants
		-0.236 (1.0361)	-0.269 (0.9759)	-0.215 (1.0584)
HAQ-DI (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		0.905 (0.7050)	0.893 (0.6691)	0.883 (0.6109)
HAQ-DI (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.024 (0.3126)	0.021 (0.2989)	0.008 (0.2942)
HAQ-DI (Change at Week 70)	Number Analyzed	244 participants	119 participants	122 participants
		-0.046 (0.3502)	-0.027 (0.2758)	0.030 (0.2950)
HAQ-DI (Change at Week 78)	Number Analyzed	239 participants	116 participants	118 participants
		-0.079 (0.3869)	-0.022 (0.3521)	0.001 (0.3800)

11. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
Description	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Time Frame	Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	324	326
Measure Type: Number; Unit of Measure: participants
ACR/EULAR remission (Week 2)	2	3
ACR/EULAR remission (Week 4)	10	11
ACR/EULAR remission (Week 6)	12	10
ACR/EULAR remission (Week 12)	28	17
ACR/EULAR remission (Week 14)	27	22
ACR/EULAR remission (Week 22)	25	20
ACR/EULAR remission (Week 30, pre-dose)	30	23
DAS remission (Week 2)	9	17
DAS remission (Week 4)	28	32
DAS remission (Week 6)	40	35
DAS remission (Week 12)	52	44
DAS remission (Week 14)	53	43
DAS remission (Week 22)	58	50
DAS remission (Week 30, pre-dose)	62	54

12. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
Description	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Time Frame	Week 38, 46 and 54 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	280	143	143
Measure Type: Number; Unit of Measure: participants
ACR/EULAR remission (Week 38)	29	15	8
ACR/EULAR remission (Week 46)	39	15	7
ACR/EULAR remission (Week 54, pre-dose)	42	18	13
DAS remission (Week 38)	74	26	25
DAS remission (Week 46)	76	30	21
DAS remission (Week 54, pre-dose)	79	33	29

13. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
Description	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Time Frame	Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	253	126	126
Measure Type: Number; Unit of Measure: participants
ACR/EULAR remission (Week 62)	46	19	20
ACR/EULAR remission (Week 70)	50	18	19
ACR/EULAR remission (Week 78)	57	19	18
DAS remission (Week 62)	85	33	34
DAS remission (Week 70)	82	40	34
DAS remission (Week 78)	94	39	41

14. Secondary Outcome

Title	Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
Description	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Time Frame	Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		324	326
Measure Type: Number; Unit of Measure: participants
Week 2 (good response)	Number Analyzed	317 participants	324 participants
		24	34
Week 2 (moderate response)	Number Analyzed	317 participants	324 participants
		172	161
Week 2 (no response)	Number Analyzed	317 participants	324 participants
		121	129
Week 4 (good response)	Number Analyzed	312 participants	315 participants
		61	56
Week 4 (moderate response)	Number Analyzed	312 participants	315 participants
		162	172
Week 4 (no response)	Number Analyzed	312 participants	315 participants
		89	87
Week 6 (good response)	Number Analyzed	312 participants	319 participants
		65	64
Week 6 (moderate response)	Number Analyzed	312 participants	319 participants
		168	181
Week 6 (no response)	Number Analyzed	312 participants	319 participants
		79	74
Week 12 (good response)	Number Analyzed	310 participants	316 participants
		90	88
Week 12 (moderate response)	Number Analyzed	310 participants	316 participants
		149	162
Week 12 (no response)	Number Analyzed	310 participants	316 participants
		71	66
Week 14 (good response)	Number Analyzed	310 participants	314 participants
		97	82
Week 14 (moderate response)	Number Analyzed	310 participants	314 participants
		137	155
Week 14 (no response)	Number Analyzed	310 participants	314 participants
		76	77
Week 22 (good response)	Number Analyzed	301 participants	307 participants
		103	96
Week 22 (moderate response)	Number Analyzed	301 participants	307 participants
		125	156
Week 22 (no response)	Number Analyzed	301 participants	307 participants
		73	55
Week 30 (good response)	Number Analyzed	292 participants	297 participants
		101	94
Week 30 (moderate response)	Number Analyzed	292 participants	297 participants
		133	155
Week 30 (no response)	Number Analyzed	292 participants	297 participants
		58	48

15. Secondary Outcome

Title	Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
Description	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Time Frame	Week 38, 46 and Week 54 (pre-dose)

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		280	143	143
Measure Type: Number; Unit of Measure: participants
Week 38 (good response)	Number Analyzed	276 participants	141 participants	140 participants
		110	51	49
Week 38 (moderate response)	Number Analyzed	276 participants	141 participants	140 participants
		132	62	66
Week 38 (no response)	Number Analyzed	276 participants	141 participants	140 participants
		34	28	25
Week 46 (good response)	Number Analyzed	266 participants	138 participants	133 participants
		107	46	49
Week 46 (moderate response)	Number Analyzed	266 participants	138 participants	133 participants
		126	64	67
Week 46 (no response)	Number Analyzed	266 participants	138 participants	133 participants
		33	28	17
Week 54 (good response)	Number Analyzed	256 participants	129 participants	128 participants
		118	53	50
Week 54 (moderate response)	Number Analyzed	256 participants	129 participants	128 participants
		109	56	62
Week 54 (no response)	Number Analyzed	256 participants	129 participants	128 participants
		29	20	16

16. Secondary Outcome

Title	Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
Description	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Time Frame	Week 62, 70 and Week 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		253	126	126
Measure Type: Number; Unit of Measure: participants
Week 62 (good response)	Number Analyzed	249 participants	123 participants	124 participants
		122	50	57
Week 62 (moderate response)	Number Analyzed	249 participants	123 participants	124 participants
		102	56	54
Week 62 (no response)	Number Analyzed	249 participants	123 participants	124 participants
		25	17	13
Week 70 (good response)	Number Analyzed	244 participants	119 participants	121 participants
		127	56	52
Week 70 (moderate response)	Number Analyzed	244 participants	119 participants	121 participants
		92	48	54
Week 70 (no response)	Number Analyzed	244 participants	119 participants	121 participants
		25	15	15
Week 78 (good response)	Number Analyzed	239 participants	114 participants	118 participants
		133	58	57
Week 78 (moderate response)	Number Analyzed	239 participants	114 participants	118 participants
		84	45	53
Week 78 (no response)	Number Analyzed	239 participants	114 participants	118 participants
		22	11	8

17. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Time Frame	Baseline (Day 1) up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	323	326
Measure Type: Number; Unit of Measure: participants
TEAEs	185	176
SAEs	16	20
Treatment related TEAEs	81	75
Treatment related SAEs	4	4

18. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Time Frame	Baseline (Week 30 pre-dose) up to Week 54

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	280	143	143
Measure Type: Number; Unit of Measure: participants
TEAEs	103	48	54
SAEs	13	11	4
Treatment related TEAEs	32	20	16
Treatment related SAEs	2	5	0

19. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Time Frame	Baseline (Week 54 pre-dose) up to Week 78

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	253	126	126
Measure Type: Number; Unit of Measure: participants
TEAEs	73	38	37
SAEs	3	3	6
Treatment related TEAEs	22	10	8
Treatment related SAEs	0	1	3

20. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
Description	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Time Frame	Baseline (Day 1) up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	323	326
Measure Type: Number; Unit of Measure: participants
TEAEs (Grade 3)	34	34
TEAEs (Grade 4)	1	6
TEAEs (Grade 5)	2	1

21. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
Description	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Time Frame	Baseline (Week 30 pre-dose) up to Week 54

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	280	143	143
Measure Type: Number; Unit of Measure: participants
TEAEs (Grade 3)	17	10	6
TEAEs (Grade 4)	3	3	0
TEAEs (Grade 5)	1	0	0

22. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
Description	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Time Frame	Baseline (Week 54 pre-dose) up to Week 78

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	253	126	126
Measure Type: Number; Unit of Measure: participants
TEAEs (Grade 3)	4	3	7
TEAEs (Grade 4)	1	0	0
TEAEs (Grade 5)	0	0	0

23. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities: Period 1
Description	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.
Time Frame	Baseline (Day 1) up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed	321	325
Measure Type: Number; Unit of Measure: participants
	245	237

24. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities: Period 2
Description	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.
Time Frame	Baseline (Week 30 pre-dose) up to Week 54

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed	279	142	141
Measure Type: Number; Unit of Measure: participants
	154	83	63

25. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities: Period 3
Description	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.
Time Frame	Baseline (Week 54 pre-dose) up to Week 78

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed	250	123	126
Measure Type: Number; Unit of Measure: participants
	127	72	61

26. Secondary Outcome

Title	Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Description	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		321	325
Mean (Standard Deviation); Unit of Measure: joints
Tender joint count (Baseline)	Number Analyzed	321 participants	325 participants
		24.7 (13.90)	25.8 (12.89)
Tender joint count (Change at Week 2)	Number Analyzed	319 participants	324 participants
		-5.9 (8.78)	-7.5 (8.39)
Tender joint count (Change at Week 4)	Number Analyzed	317 participants	321 participants
		-9.5 (10.02)	-10.4 (9.41)
Tender joint count (Change at Week 6)	Number Analyzed	313 participants	319 participants
		-10.6 (11.17)	-12.1 (10.12)
Tender joint count (Change at Week 12)	Number Analyzed	311 participants	318 participants
		-12.1 (11.84)	-13.2 (11.51)
Tender joint count (Change at Week 14)	Number Analyzed	311 participants	316 participants
		-11.8 (12.50)	-13.0 (12.15)
Tender joint count (Change at Week 22)	Number Analyzed	301 participants	311 participants
		-13.2 (12.62)	-15.2 (12.93)
Tender joint count (Change at Week 30)	Number Analyzed	294 participants	298 participants
		-14.4 (13.19)	-15.6 (12.57)
Swollen joint count (Baseline)	Number Analyzed	321 participants	325 participants
		16.1 (9.44)	16.3 (8.70)
Swollen joint count (Change at Week 2)	Number Analyzed	319 participants	324 participants
		-5.5 (6.89)	-5.7 (7.27)
Swollen joint count (Change at Week 4)	Number Analyzed	317 participants	321 participants
		-7.8 (7.75)	-7.9 (7.39)
Swollen joint count (Change at Week 6)	Number Analyzed	313 participants	319 participants
		-8.6 (7.99)	-9.0 (7.92)
Swollen joint count (Change at Week 12)	Number Analyzed	311 participants	318 participants
		-9.6 (8.61)	-9.6 (8.39)
Swollen joint count (Change at Week 14)	Number Analyzed	311 participants	316 participants
		-9.3 (8.87)	-9.6 (8.44)
Swollen joint count (Change at Week 22)	Number Analyzed	301 participants	311 participants
		-10.5 (8.77)	-10.2 (7.94)
Swollen joint count (Change at Week 30)	Number Analyzed	294 participants	298 participants
		-11.0 (9.33)	-10.7 (8.52)

27. Secondary Outcome

Title	Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
Description	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame	Baseline (Week 30 pre-dose), Week 38, 46 and Week 54

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		278	142	141
Mean (Standard Deviation); Unit of Measure: joints
Tender joint count (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		10.2 (11.74)	10.2 (11.96)	9.1 (8.89)
Tender joint count (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-1.3 (6.74)	-0.5 (8.86)	-1.0 (6.03)
Tender joint count (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-1.6 (7.87)	-1.0 (9.32)	-0.8 (7.77)
Tender joint count (Change at Week 54)	Number Analyzed	260 participants	130 participants	129 participants
		-1.7 (7.96)	-1.7 (10.23)	-0.5 (9.03)
Swollen joint count (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		4.9 (6.46)	5.3 (6.57)	4.6 (5.35)
Swollen joint count (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-0.8 (4.19)	-0.1 (4.90)	-0.3 (3.93)
Swollen joint count (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-1.2 (5.20)	0.0 (5.54)	-0.5 (4.22)
Swollen joint count (Change at Week 54)	Number Analyzed	260 participants	130 participants	129 participants
		-1.3 (5.52)	-0.9 (7.02)	-0.7 (4.10)

28. Secondary Outcome

Title	Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
Description	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame	Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		249	123	126
Mean (Standard Deviation); Unit of Measure: joints
Tender joint count (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		7.5 (9.51)	7.5 (9.21)	7.4 (7.99)
Tender joint count (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.7 (5.88)	0.3 (5.21)	-0.8 (5.18)
Tender joint count (Change at Week 70)	Number Analyzed	244 participants	119 participants	122 participants
		-1.4 (6.32)	-0.6 (5.14)	-1.0 (5.51)
Tender joint count (Change at Week 78)	Number Analyzed	239 participants	116 participants	118 participants
		-1.7 (6.57)	-1.0 (5.82)	-1.4 (6.63)
Swollen joint count (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		3.4 (5.72)	4.1 (5.16)	3.5 (4.28)
Swollen joint count (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.3 (3.76)	0.0 (4.41)	-0.3 (2.72)
Swollen joint count (Change at Week 70)	Number Analyzed	244 participants	119 participants	122 participants
		-0.7 (4.60)	-0.4 (4.12)	-0.5 (2.48)
Swollen joint count (Change at Week 78)	Number Analyzed	239 participants	116 participants	118 participants
		-0.9 (4.63)	-0.5 (4.00)	-0.2 (3.14)

29. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1
Description	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		321	325
Mean (Standard Deviation); Unit of Measure: units on a scale
PAAP (Baseline)	Number Analyzed	321 participants	325 participants
		63.514 (20.5903)	63.098 (21.5442)
PAAP (Change at Week 2)	Number Analyzed	320 participants	324 participants
		-15.724 (21.9589)	-15.360 (19.4328)
PAAP (Change at Week 4)	Number Analyzed	317 participants	321 participants
		-21.609 (22.3825)	-20.552 (21.2670)
PAAP (Change at Week 6)	Number Analyzed	314 participants	320 participants
		-23.917 (25.0213)	-22.797 (22.9133)
PAAP (Change at Week 12)	Number Analyzed	311 participants	318 participants
		-25.364 (25.6602)	-25.829 (24.8304)
PAAP (Change at Week 14)	Number Analyzed	311 participants	316 participants
		-26.131 (26.8712)	-25.077 (25.0536)
PAAP (Change at week 22)	Number Analyzed	301 participants	311 participants
		-27.844 (27.0039)	-25.788 (25.3225)
PAAP (Change at Week 30)	Number Analyzed	294 participants	298 participants
		-29.150 (27.9802)	-28.853 (26.7252)
PGA (Baseline)	Number Analyzed	321 participants	325 participants
		65.340 (20.7209)	63.752 (22.9105)
PGA (Change at Week 2)	Number Analyzed	320 participants	324 participants
		-17.262 (22.8767)	-16.504 (20.3188)
PGA (Change at Week 4)	Number Analyzed	317 participants	321 participants
		-23.393 (23.3769)	-21.355 (23.6005)
PGA (Change at Week 6)	Number Analyzed	314 participants	320 participants
		-25.536 (24.8041)	-23.314 (24.2005)
PGA (Change at Week 12)	Number Analyzed	311 participants	317 participants
		-26.882 (25.3270)	-26.535 (26.3998)
PGA (Change at Week 14)	Number Analyzed	311 participants	316 participants
		-27.583 (26.7955)	-25.323 (26.8562)
PGA (Change at Week 22)	Number Analyzed	301 participants	310 participants
		-28.558 (27.5077)	-26.486 (26.7141)
PGA (Change at Week 30)	Number Analyzed	294 participants	298 participants
		-29.186 (28.6488)	-28.814 (28.5929)
PGAA (Baseline)	Number Analyzed	319 participants	325 participants
		65.362 (16.2520)	64.126 (16.7220)
PGAA (Change at Week 2)	Number Analyzed	318 participants	324 participants
		-21.913 (18.5574)	-20.143 (17.1407)
PGAA (Change at Week 4)	Number Analyzed	315 participants	321 participants
		-29.724 (19.2226)	-27.905 (17.9803)
PGAA (Change at Week 6)	Number Analyzed	312 participants	320 participants
		-33.319 (20.1143)	-30.958 (18.9303)
PGAA (Change at Week 12)	Number Analyzed	310 participants	318 participants
		-34.827 (19.8162)	-33.919 (19.7020)
PGAA (Change at Week 14)	Number Analyzed	310 participants	316 participants
		-35.870 (21.4707)	-34.175 (20.6526)
PGAA (Change at Week 22)	Number Analyzed	300 participants	311 participants
		-37.542 (20.8619)	-36.118 (20.6564)
PGAA (Change at Week 30)	Number Analyzed	293 participants	298 participants
		-39.842 (22.0276)	-36.666 (22.1598)

30. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2
Description	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame	Baseline (Week 30 pre-dose), Week 38, 46 and 54

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		278	142	141
Mean (Standard Deviation); Unit of Measure: units on a scale
PAAP (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		33.137 (24.2922)	33.331 (22.2738)	32.559 (22.2702)
PAAP (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-0.014 (18.7502)	1.440 (14.9902)	-0.705 (18.9147)
PAAP (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-2.230 (20.0201)	1.087 (21.5811)	2.188 (20.7319)
PAAP (Change at Week 54)	Number Analyzed	259 participants	130 participants	129 participants
		-1.416 (20.7823)	-0.492 (20.8000)	1.365 (24.8362)
PGA (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		35.104 (24.8444)	33.268 (22.2621)	34.029 (22.7172)
PGA (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-1.628 (19.1471)	1.582 (16.0776)	-1.086 (17.5787)
PGA (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-3.171 (20.3050)	0.558 (20.6610)	0.535 (21.3947)
PGA (Change at Week 54)	Number Analyzed	259 participants	130 participants	129 participants
		-2.929 (20.9396)	-0.538 (21.1331)	0.776 (23.8743)
PGAA (Baseline)	Number Analyzed	278 participants	142 participants	141 participants
		25.124 (19.0943)	27.294 (18.8148)	26.091 (17.9503)
PGAA (Change at Week 38)	Number Analyzed	277 participants	141 participants	141 participants
		-1.254 (12.4789)	0.588 (16.5232)	-1.852 (15.4699)
PGAA (Change at Week 46)	Number Analyzed	269 participants	138 participants	133 participants
		-2.470 (13.9135)	0.625 (20.0163)	-0.700 (18.8038)
PGAA (Change at Week 54)	Number Analyzed	258 participants	130 participants	129 participants
		-2.252 (17.0422)	-3.398 (20.0381)	-2.969 (20.1498)

31. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3
Description	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame	Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		249	123	126
Mean (Standard Deviation); Unit of Measure: units on a scale
PAAP (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		30.395 (23.7412)	31.659 (23.2900)	31.225 (22.9366)
PAAP (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.025 (15.8259)	0.276 (12.2744)	-1.790 (16.6740)
PAAP (Change at Week 70)	Number Analyzed	244 participants	118 participants	122 participants
		-2.948 (18.1105)	-0.297 (15.4108)	-0.970 (16.7170)
PAAP (Change at Week 78)	Number Analyzed	238 participants	116 participants	118 participants
		-3.552 (18.8760)	-2.900 (18.0663)	-3.918 (20.9632)
PGA (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		30.841 (23.7807)	31.130 (23.3603)	32.710 (22.6365)
PGA (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		0.240 (16.2724)	1.463 (13.6899)	-2.226 (15.3415)
PGA (Change at Week 70)	Number Analyzed	244 participants	119 participants	122 participants
		-1.764 (18.7038)	0.101 (14.4260)	-2.093 (16.2677)
PGA (Change at Week 78)	Number Analyzed	239 participants	115 participants	118 participants
		-2.880 (19.6643)	-2.339 (17.0453)	-3.758 (19.5447)
PGAA (Baseline)	Number Analyzed	249 participants	123 participants	126 participants
		21.305 (17.6278)	21.780 (17.3354)	20.705 (16.9587)
PGAA (Change at Week 62)	Number Analyzed	249 participants	123 participants	124 participants
		-0.381 (13.6810)	2.659 (14.6314)	-0.499 (12.9483)
PGAA (Change at Week 70)	Number Analyzed	244 participants	119 participants	122 participants
		-3.217 (14.1581)	-1.160 (12.7665)	-0.810 (15.0274)
PGAA (Change at Week 78)	Number Analyzed	239 participants	116 participants	118 participants
		-2.217 (15.3894)	0.681 (15.0989)	-0.159 (17.2024)

32. Secondary Outcome

Title	Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Description	[Not Specified]
Time Frame	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		321	325
Mean (Standard Deviation); Unit of Measure: milligram/litres
Baseline	Number Analyzed	321 participants	325 participants
		25.916 (24.3118)	25.366 (28.4866)
Change at Week 2	Number Analyzed	318 participants	324 participants
		-17.183 (20.8107)	-16.140 (24.2442)
Change at Week 4	Number Analyzed	312 participants	315 participants
		-15.555 (19.5227)	-13.407 (33.9136)
Change at Week 6	Number Analyzed	313 participants	320 participants
		-14.078 (20.4984)	-13.247 (27.7801)
Change at Week 12	Number Analyzed	311 participants	317 participants
		-12.502 (23.9435)	-12.525 (27.8736)
Change at Week 14	Number Analyzed	310 participants	314 participants
		-12.613 (23.2548)	-12.392 (29.3267)
Change at Week 22	Number Analyzed	301 participants	308 participants
		-11.195 (24.5225)	-11.422 (31.0610)
Change at Week 30	Number Analyzed	292 participants	297 participants
		-12.165 (25.6612)	-12.390 (30.0352)

33. Secondary Outcome

Title	Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2
Description	[Not Specified]
Time Frame	Baseline (Week 30 pre-dose), Week 38, 46 and 54

Outcome Measure Data

Analysis Population Description

The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		278	142	141
Mean (Standard Deviation); Unit of Measure: milligrams/litres
Baseline	Number Analyzed	278 participants	142 participants	141 participants
		12.970 (19.1927)	14.427 (21.1595)	10.847 (14.8018)
Change at Week 38	Number Analyzed	276 participants	141 participants	140 participants
		0.496 (18.7859)	1.805 (19.5138)	0.093 (14.8441)
Change at Week 46	Number Analyzed	266 participants	138 participants	133 participants
		1.210 (16.1727)	3.996 (24.4986)	0.798 (15.7687)
Change at Week 54	Number Analyzed	256 participants	129 participants	128 participants
		0.639 (21.1226)	2.988 (24.5492)	1.264 (13.6788)

34. Secondary Outcome

Title	Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3
Description	[Not Specified]
Time Frame	Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome Measure Data

Analysis Population Description

The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		249	123	126
Mean (Standard Deviation); Unit of Measure: milligrams/litres
Baseline	Number Analyzed	249 participants	123 participants	126 participants
		13.112 (21.3781)	16.096 (24.1595)	11.985 (13.8159)
Change at Week 62	Number Analyzed	249 participants	123 participants	124 participants
		-0.635 (19.9660)	-3.648 (21.6177)	-0.541 (9.3198)
Change at Week 70	Number Analyzed	244 participants	119 participants	121 participants
		-0.320 (23.1234)	-4.199 (22.3368)	-0.339 (11.7095)
Change at Week 78	Number Analyzed	239 participants	115 participants	118 participants
		-1.660 (19.6340)	-3.565 (23.9800)	0.811 (14.7061)

35. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
Description	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Time Frame	Baseline (Day 1) up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		323	326
Measure Type: Number; Unit of Measure: participants
ADA	Number Analyzed	323 participants	326 participants
		157	167
NAb	Number Analyzed	157 participants	167 participants
		124	143

36. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
Description	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Time Frame	Baseline (Week 30 pre-dose) up to Week 54

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		280	143	143
Measure Type: Number; Unit of Measure: participants
ADA	Number Analyzed	280 participants	143 participants	143 participants
		146	86	83
NAb	Number Analyzed	146 participants	86 participants	83 participants
		118	73	65

37. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
Description	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Time Frame	Baseline (Week 54 pre-dose) up to Week 78

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		253	126	126
Measure Type: Number; Unit of Measure: participants
ADA	Number Analyzed	253 participants	126 participants	126 participants
		119	66	72
NAb	Number Analyzed	119 participants	66 participants	72 participants
		105	58	60

38. Secondary Outcome

Title	Serum Concentration Versus Time Summary: Period 1
Description	[Not Specified]
Time Frame	Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.

Arm/Group Title		Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)
Arm/Group Description:		Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Overall Number of Participants Analyzed		323	326
Median (Standard Deviation); Unit of Measure: nanograms/milliliters
Day 1 (0 hours)	Number Analyzed	322 participants	323 participants
		1635 (11163)	656.2 (6583.8)
Day 1 (2 hours)	Number Analyzed	319 participants	322 participants
		65310 (24920)	62220 (22129)
Day 15 (0 hours)	Number Analyzed	316 participants	323 participants
		17350 (8391.4)	16690 (8002.7)
Day 29 (336 hours)	Number Analyzed	308 participants	314 participants
		23640 (12357)	21570 (10986)
Day 43 (0 hours)	Number Analyzed	308 participants	315 participants
		11440 (10101)	10100 (7721.7)
Day 99 (0 hours)	Number Analyzed	302 participants	310 participants
		3547 (9559.2)	2559 (6360.3)
Day 99 (2 hours)	Number Analyzed	297 participants	299 participants
		76030 (39407)	73350 (41410)
Day 155 (0 hours)	Number Analyzed	295 participants	303 participants
		2051 (3440.9)	1566 (2321.4)
Day 211 (0 hours)	Number Analyzed	281 participants	290 participants
		1781 (2765.2)	2112 (11703)

39. Secondary Outcome

Title	Serum Concentration Versus Time Summary: Period 2
Description	[Not Specified]
Time Frame	Pre dose on Day 211, 267, 379 and 547

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.

Arm/Group Title		Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179
Arm/Group Description:		Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Overall Number of Participants Analyzed		280	143	143
Mean (Standard Deviation); Unit of Measure: nanograms/milliliters
Day 211 (0 hours)	Number Analyzed	278 participants	143 participants	142 participants
		1801 (2773.4)	1083 (1763.6)	1819 (2393.5)
Day 267 (0 hours)	Number Analyzed	272 participants	136 participants	133 participants
		1855 (2871.7)	1208 (1926.5)	1620 (2413.7)
Day 379 (0 hours)	Number Analyzed	248 participants	125 participants	125 participants
		2075 (4054.6)	1823 (6110.8)	1734 (2725.2)
Day 547 (0 hours)	Number Analyzed	16 participants	14 participants	11 participants
		499.6 (1373.0)	212.7 (405.18)	3305 (8429.5)

40. Secondary Outcome

Title	Serum Concentration Versus Time Summary: Period 3
Description	[Not Specified]
Time Frame	Pre dose on Day 379, 435 and 547

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.

Arm/Group Title		Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description:		Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Overall Number of Participants Analyzed		253	126	126
Mean (Standard Deviation); Unit of Measure: nanograms/milliliters
Day 379 (0 hours)	Number Analyzed	250 participants	125 participants	125 participants
		2078 (4044.0)	1823 (6110.8)	1734 (2725.2)
Day 435 (0 hours)	Number Analyzed	243 participants	118 participants	123 participants
		1913 (2838.0)	1388 (2387.4)	1572 (2543.4)
Day 547	Number Analyzed	243 participants	121 participants	119 participants
		1707 (2512.9)	1663 (5305.7)	1482 (2441.6)

Adverse Events

Time Frame	Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78
Adverse Event Reporting Description	Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Arm/Group Title	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
Arm/Group Description	Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
All-Cause Mortality
	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/323 (4.95%)	20/326 (6.13%)	13/280 (4.64%)	11/143 (7.69%)	4/143 (2.80%)	3/253 (1.19%)	3/126 (2.38%)	6/126 (4.76%)
Blood and lymphatic system disorders
Anaemia * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Blood disorder * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	1/143 (0.70%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Cardiac disorders
Acute myocardial infarction * 1	2/323 (0.62%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Angina unstable * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Atrial fibrillation * 1	0/323 (0.00%)	2/326 (0.61%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Atrial flutter * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Coronary artery disease * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Myocardial infarction * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	1/253 (0.40%)	0/126 (0.00%)	0/126 (0.00%)
Eye disorders
Keratitis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Gastrointestinal disorders
Diverticular perforation * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Dyspepsia * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Enteritis * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Haemorrhoids * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
General disorders
Chest pain * 1	2/323 (0.62%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Multi-organ disorder * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Systemic inflammatory response syndrome * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pyrexia * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Sudden cardiac death * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Hepatobiliary disorders
Cholecystitis * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Immune system disorders
Anaphylactic reaction * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Infections and infestations
Bronchitis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Cellulitis * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Diverticulitis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Gastroenteritis norovirus * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Localised infection * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Peritonitis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pneumocystis jirovecii pneumonia * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pneumonia * 1	2/323 (0.62%)	2/326 (0.61%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Purulent synovitis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pyelonephritis acute * 1	1/323 (0.31%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Subcutaneous abscess * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Tuberculosis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Urinary tract infection * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	1/143 (0.70%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Acute sinusitis * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Arthritis bacterial * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Clostridium difficile infection * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Helicobacter infection * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Bone abscess * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	1/126 (0.79%)	0/126 (0.00%)
Chronic sinusitis * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Encephalitis * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Injury, poisoning and procedural complications
Cartilage injury * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Contusion * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Fall * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Hip fracture * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Ligament rupture * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Meniscus injury * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Multiple injuries * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Patella fracture * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Radius fracture * 1	0/323 (0.00%)	1/326 (0.31%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Sternal fracture * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Femur fracture * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Joint injury * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Spinal compression fracture * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	1/143 (0.70%)	0/253 (0.00%)	1/126 (0.79%)	0/126 (0.00%)
Infusion related reaction * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Hand fracture * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	1/253 (0.40%)	0/126 (0.00%)	0/126 (0.00%)
Investigations
Aspartate aminotransferase increased * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Hepatic enzyme increased * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Alanine aminotransferase increased * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis * 1	1/323 (0.31%)	1/326 (0.31%)	0/280 (0.00%)	2/143 (1.40%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Osteoarthritis * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Back pain * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Spinal pain * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	1/126 (0.79%)	0/126 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Laryngeal squamous cell carcinoma * 2	0/323 (0.00%)	0/326 (0.00%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Ocular lymphoma * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	1/143 (0.70%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Bladder cancer * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	1/253 (0.40%)	0/126 (0.00%)	0/126 (0.00%)
Nervous system disorders
Transient ischaemic attack * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Reproductive system and breast disorders
Genital prolapse * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	1/143 (0.70%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Endometriosis * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	1/126 (0.79%)	0/126 (0.00%)
Menometrorrhagia * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	1/126 (0.79%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Interstitial lung disease * 1	1/323 (0.31%)	0/326 (0.00%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pleurisy * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pulmonary embolism * 1	0/323 (0.00%)	1/326 (0.31%)	1/280 (0.36%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Dyspnoea * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Pulmonary mass * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Skin and subcutaneous tissue disorders
Erythema * 2	0/323 (0.00%)	0/326 (0.00%)	0/280 (0.00%)	1/143 (0.70%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Vascular disorders
Shock * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Venous stenosis * 1	0/323 (0.00%)	1/326 (0.31%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 19.0; 2 Term from vocabulary, MedDRA 19.0; 20.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Period 1: PF-06438179	Period 1: Infliximab-EU Remicade (INX)	Period 2: PF-06438179/PF-06438179	Period 2: INX/INX	Period 2: INX/PF-06438179	Period 3: PF-06438179/PF-06438179/PF-06438179	Period 3: INX/INX/PF-06438179	Period 3: INX/PF-06438179/PF-06438179
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	38/323 (11.76%)	35/326 (10.74%)	8/280 (2.86%)	11/143 (7.69%)	6/143 (4.20%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Injury, poisoning and procedural complications
Infusion related reaction * 1	19/323 (5.88%)	21/326 (6.44%)	8/280 (2.86%)	11/143 (7.69%)	6/143 (4.20%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
Investigations
Alanine aminotransferase increased * 1	19/323 (5.88%)	15/326 (4.60%)	0/280 (0.00%)	0/143 (0.00%)	0/143 (0.00%)	0/253 (0.00%)	0/126 (0.00%)	0/126 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 19.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

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

Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z.

Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.

Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019.

Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02222493
• Other Study ID Numbers: B5371002; REFLECTIONS B537-02 ( Other Identifier: Alias ID ); 2013-004148-49 ( EudraCT Number )
• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Results First Submitted: June 26, 2017
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018