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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02222493
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : September 11, 2017
Last Update Posted : May 30, 2018
Sponsor:
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
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)
Hide 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
Arm/Group Title PF-06438179 Infliximab-EU Remicade (INX) Total
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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]
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
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Hide 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
Hide 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
Hide 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)
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Hide 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)
Hide 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
Hide 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)
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Hide 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
Hide 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
Hide 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
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Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Baseline (Week 30 pre-dose), Week 38, 46 and 54
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Baseline (Week 54 pre-dose), Week 62, 70 and 78
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Pre dose on Day 211, 267, 379 and 547
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Pre dose on Day 379, 435 and 547
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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