Skip to content

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

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222493
Enrollment
650
Registered
2014-08-21
Start date
2014-08-26
Completion date
2017-06-01
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Phase 3, infliximab, rheumatoid arthritis

Brief summary

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

Interventions

BIOLOGICALPF-06438179

PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

BIOLOGICALInfliximab

Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. HS-CRP equal or greater than 10 mg/L. Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.

Exclusion criteria

Evidence of untreated or inadequately treated latent or active TB. Evidence or history of moderate or severe heart failure (NYHA Class III/IV) Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1Week 14ACR20 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).

Secondary

MeasureTime frameDescription
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 38, 46 and 54 (pre-dose)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.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 62, 70 and 78ACR20 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.
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 1Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)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.
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 38, 46 and 54 (pre-dose)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.
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3Week 62, 70 and 78ACR50 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.
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 1Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30DAS28 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.
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2Baseline (Week 30 pre-dose), Week 38, 46 and 54DAS28 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.
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3Baseline (Week 54 pre-dose), Week 62, 70 and 78DAS28 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.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)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.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2Week 38, 46 and 54 (pre-dose)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.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3Week 62, 70 and 78ACR/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.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)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.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38, 46 and Week 54 (pre-dose)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.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62, 70 and Week 78EULAR 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.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30Tender 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1Baseline (Day 1) up to Week 30An 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Baseline (Week 30 pre-dose) up to Week 54An 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Baseline (Week 54 pre-dose) up to Week 78An 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1Baseline (Day 1) up to Week 30AEs 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.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 2, 4, 6, 12, 22 and 30 (pre-dose)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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3Baseline (Week 54 pre-dose) up to Week 78AEs 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.
Number of Participants With Laboratory Abnormalities: Period 1Baseline (Day 1) up to Week 30Criteria 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.
Number of Participants With Laboratory Abnormalities: Period 2Baseline (Week 30 pre-dose) up to Week 54Criteria 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.
Number of Participants With Laboratory Abnormalities: Period 3Baseline (Week 54 pre-dose) up to Week 78Criteria 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.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Baseline (Week 30 pre-dose), Week 38, 46 and Week 54Tender 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.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Baseline (Week 54 pre-dose), Week 62, 70 and 78Tender 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.
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 1Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30PAAP: 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.
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 2Baseline (Week 30 pre-dose), Week 38, 46 and 54PAAP: 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.
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 3Baseline (Week 54 pre-dose), Week 62, 70 and 78PAAP: 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.
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Baseline (Week 54 pre-dose), Week 62, 70 and 78
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1Baseline (Day 1) up to Week 30ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2Baseline (Week 30 pre-dose) up to Week 54ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3Baseline (Week 54 pre-dose) up to Week 78ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Serum Concentration Versus Time Summary: Period 1Pre 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
Serum Concentration Versus Time Summary: Period 2Pre dose on Day 211, 267, 379 and 547
Serum Concentration Versus Time Summary: Period 3Pre dose on Day 379, 435 and 547
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2Baseline (Week 30 pre-dose) up to Week 54AEs 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.

Countries

Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Czechia, Georgia, Germany, Guatemala, Hungary, Israel, Japan, Jordan, Lithuania, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Tunisia, Ukraine, United Kingdom, United States

Participant flow

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.

Participants by arm

ArmCount
PF-06438179
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.
324
Infliximab-EU Remicade (INX)
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.
326
Total650

Withdrawals & dropouts

PeriodReasonFG000FG001
Period 1: First Dose-Week 30 (Pre-dose)Adverse Event1820
Period 1: First Dose-Week 30 (Pre-dose)Death22
Period 1: First Dose-Week 30 (Pre-dose)Insufficient clinical response07
Period 1: First Dose-Week 30 (Pre-dose)Lost to Follow-up01
Period 1: First Dose-Week 30 (Pre-dose)Non-compliance with study treatment10
Period 1: First Dose-Week 30 (Pre-dose)Other40
Period 1: First Dose-Week 30 (Pre-dose)Pregnancy20
Period 1: First Dose-Week 30 (Pre-dose)Protocol Violation51
Period 1: First Dose-Week 30 (Pre-dose)Randomized but not treated10
Period 1: First Dose-Week 30 (Pre-dose)Withdrawal by Subject119
Period 2: Week30 Dosing-Week54(Pre-dose)Adverse Event229
Period 2: Week30 Dosing-Week54(Pre-dose)Death10
Period 2: Week30 Dosing-Week54(Pre-dose)Insufficient clinical response93
Period 2: Week30 Dosing-Week54(Pre-dose)Lost to Follow-up11
Period 2: Week30 Dosing-Week54(Pre-dose)Non-compliance with study treatment10
Period 2: Week30 Dosing-Week54(Pre-dose)Other30
Period 2: Week30 Dosing-Week54(Pre-dose)Withdrawal by Subject64
Period 3: Week 54 Dosing-Week 78 VisitAdverse Event140
Period 3: Week 54 Dosing-Week 78 VisitInsufficient clinical response30
Period 3: Week 54 Dosing-Week 78 VisitNon-compliance with study treatment10
Period 3: Week 54 Dosing-Week 78 VisitOther40
Period 3: Week 54 Dosing-Week 78 VisitWithdrawal by Subject90

Baseline characteristics

CharacteristicPF-06438179Infliximab-EU Remicade (INX)Total
Age, Continuous52.8 years
STANDARD_DEVIATION 13.3
52.8 years
STANDARD_DEVIATION 12.9
52.8 years
STANDARD_DEVIATION 13.1
Sex: Female, Male
Female
258 Participants264 Participants522 Participants
Sex: Female, Male
Male
66 Participants62 Participants128 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
38 / 32335 / 3268 / 28011 / 1436 / 1430 / 2530 / 1260 / 126
serious
Total, serious adverse events
16 / 32320 / 32613 / 28011 / 1434 / 1433 / 2533 / 1266 / 126

Outcome results

Primary

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

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

Population: 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.

ArmMeasureValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1198 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1207 participants
Comparison: Score statistic method95% CI: [-9.92, 5.11]
Comparison: Score statistic method90% CI: [-8.75, 4.02]
Secondary

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

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change 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 1DAS28-CRP (Baseline)5.950 units on a scaleStandard Deviation 0.9577
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 2)-1.213 units on a scaleStandard Deviation 0.928
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 4)-1.596 units on a scaleStandard Deviation 1.1259
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 6)-1.710 units on a scaleStandard Deviation 1.1959
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 12)-1.898 units on a scaleStandard Deviation 1.3516
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 14)-1.901 units on a scaleStandard Deviation 1.4125
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 22)-2.005 units on a scaleStandard Deviation 1.4236
Period 1: PF-06438179Change 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 1DAS28-CRP (Change at Week 30)-2.140 units on a scaleStandard Deviation 1.4197
Period 1: PF-06438179Change 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 1HAQ-DI (Baseline)1.623 units on a scaleStandard Deviation 0.6485
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 2)-0.317 units on a scaleStandard Deviation 0.41
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 4)-0.472 units on a scaleStandard Deviation 0.4728
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 6)-0.496 units on a scaleStandard Deviation 0.5505
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 12)-0.535 units on a scaleStandard Deviation 0.5795
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 14)-0.572 units on a scaleStandard Deviation 0.591
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 22)-0.588 units on a scaleStandard Deviation 0.6061
Period 1: PF-06438179Change 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 1HAQ-DI (Change at Week 30)-0.621 units on a scaleStandard Deviation 0.6484
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 30)-0.612 units on a scaleStandard Deviation 0.6546
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Baseline)5.983 units on a scaleStandard Deviation 0.921
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Baseline)1.586 units on a scaleStandard Deviation 0.649
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 2)-1.241 units on a scaleStandard Deviation 0.8879
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 12)-0.524 units on a scaleStandard Deviation 0.5857
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 4)-1.605 units on a scaleStandard Deviation 1.0881
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 2)-0.328 units on a scaleStandard Deviation 0.437
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 6)-1.750 units on a scaleStandard Deviation 1.0885
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 22)-0.569 units on a scaleStandard Deviation 0.5958
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 12)-1.885 units on a scaleStandard Deviation 1.2142
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 4)-0.477 units on a scaleStandard Deviation 0.4861
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 14)-1.827 units on a scaleStandard Deviation 1.3019
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 14)-0.531 units on a scaleStandard Deviation 0.5876
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 22)-2.002 units on a scaleStandard Deviation 1.2972
Period 1: Infliximab-EU Remicade (INX)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 1HAQ-DI (Change at Week 6)-0.520 units on a scaleStandard Deviation 0.5022
Period 1: Infliximab-EU Remicade (INX)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 1DAS28-CRP (Change at Week 30)-2.117 units on a scaleStandard Deviation 1.2738
Secondary

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Baseline)3.765 units on a scaleStandard Deviation 1.4629
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 38)-0.181 units on a scaleStandard Deviation 0.9574
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 46)-0.228 units on a scaleStandard Deviation 1.0453
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 54)-0.275 units on a scaleStandard Deviation 1.1338
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Baseline)0.978 units on a scaleStandard Deviation 0.7042
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 38)-0.019 units on a scaleStandard Deviation 0.3328
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 46)-0.043 units on a scaleStandard Deviation 0.3774
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 54)-0.026 units on a scaleStandard Deviation 0.4407
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 46)0.048 units on a scaleStandard Deviation 1.2584
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 46)0.014 units on a scaleStandard Deviation 0.3823
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 54)-0.109 units on a scaleStandard Deviation 1.1801
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Baseline)0.913 units on a scaleStandard Deviation 0.6634
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 38)0.019 units on a scaleStandard Deviation 0.2889
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Baseline)3.819 units on a scaleStandard Deviation 1.3624
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 38)0.036 units on a scaleStandard Deviation 0.8686
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 54)0.017 units on a scaleStandard Deviation 0.4399
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 46)-0.017 units on a scaleStandard Deviation 1.0692
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 38)-0.059 units on a scaleStandard Deviation 0.8756
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Baseline)3.781 units on a scaleStandard Deviation 1.2547
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2DAS28-CRP (Change at Week 54)-0.057 units on a scaleStandard Deviation 1.2339
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 46)0.035 units on a scaleStandard Deviation 0.4325
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 38)0.007 units on a scaleStandard Deviation 0.3688
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Baseline)0.951 units on a scaleStandard Deviation 0.6481
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2HAQ-DI (Change at Week 54)-0.044 units on a scaleStandard Deviation 0.3881
Secondary

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Baseline)3.386 units on a scaleStandard Deviation 1.3229
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 62)-0.072 units on a scaleStandard Deviation 0.915
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 70)-0.157 units on a scaleStandard Deviation 0.9502
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 78)-0.236 units on a scaleStandard Deviation 1.0361
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Baseline)0.905 units on a scaleStandard Deviation 0.705
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 62)-0.024 units on a scaleStandard Deviation 0.3126
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 70)-0.046 units on a scaleStandard Deviation 0.3502
Period 1: PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 78)-0.079 units on a scaleStandard Deviation 0.3869
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 70)-0.168 units on a scaleStandard Deviation 0.8421
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 70)-0.027 units on a scaleStandard Deviation 0.2758
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 78)-0.269 units on a scaleStandard Deviation 0.9759
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Baseline)0.893 units on a scaleStandard Deviation 0.6691
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 62)0.021 units on a scaleStandard Deviation 0.2989
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Baseline)3.561 units on a scaleStandard Deviation 1.3123
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 62)-0.004 units on a scaleStandard Deviation 0.819
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 78)-0.022 units on a scaleStandard Deviation 0.3521
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 70)-0.162 units on a scaleStandard Deviation 0.797
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 62)-0.154 units on a scaleStandard Deviation 0.684
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Baseline)3.594 units on a scaleStandard Deviation 1.2572
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3DAS28-CRP (Change at Week 78)-0.215 units on a scaleStandard Deviation 1.0584
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 70)0.030 units on a scaleStandard Deviation 0.295
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 62)0.008 units on a scaleStandard Deviation 0.2942
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Baseline)0.883 units on a scaleStandard Deviation 0.6109
Period 2: INX/PF-06438179Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3HAQ-DI (Change at Week 78)0.001 units on a scaleStandard Deviation 0.38
Secondary

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

Time frame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Baseline25.916 milligram/litresStandard Deviation 24.3118
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 2-17.183 milligram/litresStandard Deviation 20.8107
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 4-15.555 milligram/litresStandard Deviation 19.5227
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 6-14.078 milligram/litresStandard Deviation 20.4984
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 12-12.502 milligram/litresStandard Deviation 23.9435
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 14-12.613 milligram/litresStandard Deviation 23.2548
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 22-11.195 milligram/litresStandard Deviation 24.5225
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 30-12.165 milligram/litresStandard Deviation 25.6612
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 30-12.390 milligram/litresStandard Deviation 30.0352
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Baseline25.366 milligram/litresStandard Deviation 28.4866
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 12-12.525 milligram/litresStandard Deviation 27.8736
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 2-16.140 milligram/litresStandard Deviation 24.2442
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 22-11.422 milligram/litresStandard Deviation 31.061
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 4-13.407 milligram/litresStandard Deviation 33.9136
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 14-12.392 milligram/litresStandard Deviation 29.3267
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Change at Week 6-13.247 milligram/litresStandard Deviation 27.7801
Secondary

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2

Time frame: Baseline (Week 30 pre-dose), Week 38, 46 and 54

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Baseline12.970 milligrams/litresStandard Deviation 19.1927
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 380.496 milligrams/litresStandard Deviation 18.7859
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 461.210 milligrams/litresStandard Deviation 16.1727
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 540.639 milligrams/litresStandard Deviation 21.1226
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 542.988 milligrams/litresStandard Deviation 24.5492
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Baseline14.427 milligrams/litresStandard Deviation 21.1595
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 463.996 milligrams/litresStandard Deviation 24.4986
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 381.805 milligrams/litresStandard Deviation 19.5138
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 541.264 milligrams/litresStandard Deviation 13.6788
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 380.093 milligrams/litresStandard Deviation 14.8441
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Change at Week 460.798 milligrams/litresStandard Deviation 15.7687
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2Baseline10.847 milligrams/litresStandard Deviation 14.8018
Secondary

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3

Time frame: Baseline (Week 54 pre-dose), Week 62, 70 and 78

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Baseline13.112 milligrams/litresStandard Deviation 21.3781
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 62-0.635 milligrams/litresStandard Deviation 19.966
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 70-0.320 milligrams/litresStandard Deviation 23.1234
Period 1: PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 78-1.660 milligrams/litresStandard Deviation 19.634
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 78-3.565 milligrams/litresStandard Deviation 23.98
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Baseline16.096 milligrams/litresStandard Deviation 24.1595
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 70-4.199 milligrams/litresStandard Deviation 22.3368
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 62-3.648 milligrams/litresStandard Deviation 21.6177
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 780.811 milligrams/litresStandard Deviation 14.7061
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 62-0.541 milligrams/litresStandard Deviation 9.3198
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Change at Week 70-0.339 milligrams/litresStandard Deviation 11.7095
Period 2: INX/PF-06438179Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3Baseline11.985 milligrams/litresStandard Deviation 13.8159
Secondary

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

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change 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 1PAAP (Change at week 22)-27.844 units on a scaleStandard Deviation 27.0039
Period 1: PF-06438179Change 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 1PAAP (Change at Week 2)-15.724 units on a scaleStandard Deviation 21.9589
Period 1: PF-06438179Change 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 1PAAP (Change at Week 4)-21.609 units on a scaleStandard Deviation 22.3825
Period 1: PF-06438179Change 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 1PAAP (Change at Week 6)-23.917 units on a scaleStandard Deviation 25.0213
Period 1: PF-06438179Change 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 1PAAP (Change at Week 12)-25.364 units on a scaleStandard Deviation 25.6602
Period 1: PF-06438179Change 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 1PAAP (Change at Week 14)-26.131 units on a scaleStandard Deviation 26.8712
Period 1: PF-06438179Change 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 1PAAP (Baseline)63.514 units on a scaleStandard Deviation 20.5903
Period 1: PF-06438179Change 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 1PAAP (Change at Week 30)-29.150 units on a scaleStandard Deviation 27.9802
Period 1: PF-06438179Change 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 1PGA (Baseline)65.340 units on a scaleStandard Deviation 20.7209
Period 1: PF-06438179Change 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 1PGA (Change at Week 2)-17.262 units on a scaleStandard Deviation 22.8767
Period 1: PF-06438179Change 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 1PGA (Change at Week 4)-23.393 units on a scaleStandard Deviation 23.3769
Period 1: PF-06438179Change 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 1PGA (Change at Week 6)-25.536 units on a scaleStandard Deviation 24.8041
Period 1: PF-06438179Change 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 1PGA (Change at Week 12)-26.882 units on a scaleStandard Deviation 25.327
Period 1: PF-06438179Change 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 1PGA (Change at Week 14)-27.583 units on a scaleStandard Deviation 26.7955
Period 1: PF-06438179Change 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 1PGA (Change at Week 22)-28.558 units on a scaleStandard Deviation 27.5077
Period 1: PF-06438179Change 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 1PGA (Change at Week 30)-29.186 units on a scaleStandard Deviation 28.6488
Period 1: PF-06438179Change 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 1PGAA (Baseline)65.362 units on a scaleStandard Deviation 16.252
Period 1: PF-06438179Change 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 1PGAA (Change at Week 2)-21.913 units on a scaleStandard Deviation 18.5574
Period 1: PF-06438179Change 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 1PGAA (Change at Week 4)-29.724 units on a scaleStandard Deviation 19.2226
Period 1: PF-06438179Change 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 1PGAA (Change at Week 6)-33.319 units on a scaleStandard Deviation 20.1143
Period 1: PF-06438179Change 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 1PGAA (Change at Week 12)-34.827 units on a scaleStandard Deviation 19.8162
Period 1: PF-06438179Change 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 1PGAA (Change at Week 14)-35.870 units on a scaleStandard Deviation 21.4707
Period 1: PF-06438179Change 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 1PGAA (Change at Week 22)-37.542 units on a scaleStandard Deviation 20.8619
Period 1: PF-06438179Change 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 1PGAA (Change at Week 30)-39.842 units on a scaleStandard Deviation 22.0276
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 22)-36.118 units on a scaleStandard Deviation 20.6564
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Baseline)63.098 units on a scaleStandard Deviation 21.5442
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 12)-26.535 units on a scaleStandard Deviation 26.3998
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 2)-15.360 units on a scaleStandard Deviation 19.4328
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 4)-27.905 units on a scaleStandard Deviation 17.9803
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 4)-20.552 units on a scaleStandard Deviation 21.267
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 14)-25.323 units on a scaleStandard Deviation 26.8562
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 6)-22.797 units on a scaleStandard Deviation 22.9133
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 14)-34.175 units on a scaleStandard Deviation 20.6526
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 12)-25.829 units on a scaleStandard Deviation 24.8304
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 22)-26.486 units on a scaleStandard Deviation 26.7141
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 14)-25.077 units on a scaleStandard Deviation 25.0536
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 6)-30.958 units on a scaleStandard Deviation 18.9303
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at week 22)-25.788 units on a scaleStandard Deviation 25.3225
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 30)-28.814 units on a scaleStandard Deviation 28.5929
Period 1: Infliximab-EU Remicade (INX)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 1PAAP (Change at Week 30)-28.853 units on a scaleStandard Deviation 26.7252
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 30)-36.666 units on a scaleStandard Deviation 22.1598
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Baseline)63.752 units on a scaleStandard Deviation 22.9105
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Baseline)64.126 units on a scaleStandard Deviation 16.722
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 2)-16.504 units on a scaleStandard Deviation 20.3188
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 12)-33.919 units on a scaleStandard Deviation 19.702
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 4)-21.355 units on a scaleStandard Deviation 23.6005
Period 1: Infliximab-EU Remicade (INX)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 1PGAA (Change at Week 2)-20.143 units on a scaleStandard Deviation 17.1407
Period 1: Infliximab-EU Remicade (INX)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 1PGA (Change at Week 6)-23.314 units on a scaleStandard Deviation 24.2005
Secondary

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

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change 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 2PAAP (Baseline)33.137 units on a scaleStandard Deviation 24.2922
Period 1: PF-06438179Change 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 2PAAP (Change at Week 38)-0.014 units on a scaleStandard Deviation 18.7502
Period 1: PF-06438179Change 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 2PAAP (Change at Week 46)-2.230 units on a scaleStandard Deviation 20.0201
Period 1: PF-06438179Change 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 2PAAP (Change at Week 54)-1.416 units on a scaleStandard Deviation 20.7823
Period 1: PF-06438179Change 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 2PGA (Baseline)35.104 units on a scaleStandard Deviation 24.8444
Period 1: PF-06438179Change 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 2PGA (Change at Week 38)-1.628 units on a scaleStandard Deviation 19.1471
Period 1: PF-06438179Change 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 2PGA (Change at Week 46)-3.171 units on a scaleStandard Deviation 20.305
Period 1: PF-06438179Change 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 2PGA (Change at Week 54)-2.929 units on a scaleStandard Deviation 20.9396
Period 1: PF-06438179Change 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 2PGAA (Baseline)25.124 units on a scaleStandard Deviation 19.0943
Period 1: PF-06438179Change 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 2PGAA (Change at Week 38)-1.254 units on a scaleStandard Deviation 12.4789
Period 1: PF-06438179Change 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 2PGAA (Change at Week 46)-2.470 units on a scaleStandard Deviation 13.9135
Period 1: PF-06438179Change 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 2PGAA (Change at Week 54)-2.252 units on a scaleStandard Deviation 17.0422
Period 1: Infliximab-EU Remicade (INX)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 2PGAA (Change at Week 54)-3.398 units on a scaleStandard Deviation 20.0381
Period 1: Infliximab-EU Remicade (INX)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 2PAAP (Baseline)33.331 units on a scaleStandard Deviation 22.2738
Period 1: Infliximab-EU Remicade (INX)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 2PGA (Change at Week 46)0.558 units on a scaleStandard Deviation 20.661
Period 1: Infliximab-EU Remicade (INX)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 2PGAA (Baseline)27.294 units on a scaleStandard Deviation 18.8148
Period 1: Infliximab-EU Remicade (INX)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 2PAAP (Change at Week 38)1.440 units on a scaleStandard Deviation 14.9902
Period 1: Infliximab-EU Remicade (INX)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 2PGA (Change at Week 38)1.582 units on a scaleStandard Deviation 16.0776
Period 1: Infliximab-EU Remicade (INX)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 2PGAA (Change at Week 46)0.625 units on a scaleStandard Deviation 20.0163
Period 1: Infliximab-EU Remicade (INX)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 2PAAP (Change at Week 46)1.087 units on a scaleStandard Deviation 21.5811
Period 1: Infliximab-EU Remicade (INX)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 2PGA (Change at Week 54)-0.538 units on a scaleStandard Deviation 21.1331
Period 1: Infliximab-EU Remicade (INX)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 2PGA (Baseline)33.268 units on a scaleStandard Deviation 22.2621
Period 1: Infliximab-EU Remicade (INX)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 2PAAP (Change at Week 54)-0.492 units on a scaleStandard Deviation 20.8
Period 1: Infliximab-EU Remicade (INX)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 2PGAA (Change at Week 38)0.588 units on a scaleStandard Deviation 16.5232
Period 2: INX/PF-06438179Change 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 2PAAP (Change at Week 54)1.365 units on a scaleStandard Deviation 24.8362
Period 2: INX/PF-06438179Change 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 2PGA (Baseline)34.029 units on a scaleStandard Deviation 22.7172
Period 2: INX/PF-06438179Change 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 2PGAA (Change at Week 38)-1.852 units on a scaleStandard Deviation 15.4699
Period 2: INX/PF-06438179Change 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 2PGA (Change at Week 38)-1.086 units on a scaleStandard Deviation 17.5787
Period 2: INX/PF-06438179Change 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 2PGA (Change at Week 46)0.535 units on a scaleStandard Deviation 21.3947
Period 2: INX/PF-06438179Change 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 2PGA (Change at Week 54)0.776 units on a scaleStandard Deviation 23.8743
Period 2: INX/PF-06438179Change 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 2PGAA (Change at Week 46)-0.700 units on a scaleStandard Deviation 18.8038
Period 2: INX/PF-06438179Change 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 2PAAP (Baseline)32.559 units on a scaleStandard Deviation 22.2702
Period 2: INX/PF-06438179Change 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 2PAAP (Change at Week 38)-0.705 units on a scaleStandard Deviation 18.9147
Period 2: INX/PF-06438179Change 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 2PGAA (Baseline)26.091 units on a scaleStandard Deviation 17.9503
Period 2: INX/PF-06438179Change 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 2PAAP (Change at Week 46)2.188 units on a scaleStandard Deviation 20.7319
Period 2: INX/PF-06438179Change 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 2PGAA (Change at Week 54)-2.969 units on a scaleStandard Deviation 20.1498
Secondary

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

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change 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 3PGA (Change at Week 70)-1.764 units on a scaleStandard Deviation 18.7038
Period 1: PF-06438179Change 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 3PAAP (Change at Week 62)-0.025 units on a scaleStandard Deviation 15.8259
Period 1: PF-06438179Change 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 3PAAP (Baseline)30.395 units on a scaleStandard Deviation 23.7412
Period 1: PF-06438179Change 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 3PGAA (Change at Week 78)-2.217 units on a scaleStandard Deviation 15.3894
Period 1: PF-06438179Change 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 3PAAP (Change at Week 70)-2.948 units on a scaleStandard Deviation 18.1105
Period 1: PF-06438179Change 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 3PGA (Change at Week 62)0.240 units on a scaleStandard Deviation 16.2724
Period 1: PF-06438179Change 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 3PGAA (Change at Week 70)-3.217 units on a scaleStandard Deviation 14.1581
Period 1: PF-06438179Change 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 3PAAP (Change at Week 78)-3.552 units on a scaleStandard Deviation 18.876
Period 1: PF-06438179Change 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 3PGAA (Baseline)21.305 units on a scaleStandard Deviation 17.6278
Period 1: PF-06438179Change 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 3PGA (Change at Week 78)-2.880 units on a scaleStandard Deviation 19.6643
Period 1: PF-06438179Change 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 3PGA (Baseline)30.841 units on a scaleStandard Deviation 23.7807
Period 1: PF-06438179Change 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 3PGAA (Change at Week 62)-0.381 units on a scaleStandard Deviation 13.681
Period 1: Infliximab-EU Remicade (INX)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 3PGA (Baseline)31.130 units on a scaleStandard Deviation 23.3603
Period 1: Infliximab-EU Remicade (INX)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 3PGAA (Change at Week 62)2.659 units on a scaleStandard Deviation 14.6314
Period 1: Infliximab-EU Remicade (INX)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 3PGAA (Change at Week 70)-1.160 units on a scaleStandard Deviation 12.7665
Period 1: Infliximab-EU Remicade (INX)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 3PGAA (Change at Week 78)0.681 units on a scaleStandard Deviation 15.0989
Period 1: Infliximab-EU Remicade (INX)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 3PAAP (Baseline)31.659 units on a scaleStandard Deviation 23.29
Period 1: Infliximab-EU Remicade (INX)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 3PGAA (Baseline)21.780 units on a scaleStandard Deviation 17.3354
Period 1: Infliximab-EU Remicade (INX)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 3PAAP (Change at Week 62)0.276 units on a scaleStandard Deviation 12.2744
Period 1: Infliximab-EU Remicade (INX)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 3PGA (Change at Week 70)0.101 units on a scaleStandard Deviation 14.426
Period 1: Infliximab-EU Remicade (INX)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 3PAAP (Change at Week 70)-0.297 units on a scaleStandard Deviation 15.4108
Period 1: Infliximab-EU Remicade (INX)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 3PGA (Change at Week 62)1.463 units on a scaleStandard Deviation 13.6899
Period 1: Infliximab-EU Remicade (INX)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 3PAAP (Change at Week 78)-2.900 units on a scaleStandard Deviation 18.0663
Period 1: Infliximab-EU Remicade (INX)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 3PGA (Change at Week 78)-2.339 units on a scaleStandard Deviation 17.0453
Period 2: INX/PF-06438179Change 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 3PAAP (Change at Week 70)-0.970 units on a scaleStandard Deviation 16.717
Period 2: INX/PF-06438179Change 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 3PGA (Change at Week 62)-2.226 units on a scaleStandard Deviation 15.3415
Period 2: INX/PF-06438179Change 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 3PGA (Change at Week 70)-2.093 units on a scaleStandard Deviation 16.2677
Period 2: INX/PF-06438179Change 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 3PGA (Change at Week 78)-3.758 units on a scaleStandard Deviation 19.5447
Period 2: INX/PF-06438179Change 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 3PAAP (Baseline)31.225 units on a scaleStandard Deviation 22.9366
Period 2: INX/PF-06438179Change 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 3PAAP (Change at Week 62)-1.790 units on a scaleStandard Deviation 16.674
Period 2: INX/PF-06438179Change 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 3PGA (Baseline)32.710 units on a scaleStandard Deviation 22.6365
Period 2: INX/PF-06438179Change 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 3PAAP (Change at Week 78)-3.918 units on a scaleStandard Deviation 20.9632
Period 2: INX/PF-06438179Change 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 3PGAA (Baseline)20.705 units on a scaleStandard Deviation 16.9587
Period 2: INX/PF-06438179Change 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 3PGAA (Change at Week 62)-0.499 units on a scaleStandard Deviation 12.9483
Period 2: INX/PF-06438179Change 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 3PGAA (Change at Week 70)-0.810 units on a scaleStandard Deviation 15.0274
Period 2: INX/PF-06438179Change 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 3PGAA (Change at Week 78)-0.159 units on a scaleStandard Deviation 17.2024
Secondary

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Baseline)24.7 jointsStandard Deviation 13.9
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 2)-5.9 jointsStandard Deviation 8.78
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 4)-9.5 jointsStandard Deviation 10.02
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 6)-10.6 jointsStandard Deviation 11.17
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 12)-12.1 jointsStandard Deviation 11.84
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 14)-11.8 jointsStandard Deviation 12.5
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 22)-13.2 jointsStandard Deviation 12.62
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 30)-14.4 jointsStandard Deviation 13.19
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Baseline)16.1 jointsStandard Deviation 9.44
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 2)-5.5 jointsStandard Deviation 6.89
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 4)-7.8 jointsStandard Deviation 7.75
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 6)-8.6 jointsStandard Deviation 7.99
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 12)-9.6 jointsStandard Deviation 8.61
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 14)-9.3 jointsStandard Deviation 8.87
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 22)-10.5 jointsStandard Deviation 8.77
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 30)-11.0 jointsStandard Deviation 9.33
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 30)-10.7 jointsStandard Deviation 8.52
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Baseline)25.8 jointsStandard Deviation 12.89
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Baseline)16.3 jointsStandard Deviation 8.7
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 2)-7.5 jointsStandard Deviation 8.39
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 12)-9.6 jointsStandard Deviation 8.39
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 4)-10.4 jointsStandard Deviation 9.41
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 2)-5.7 jointsStandard Deviation 7.27
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 6)-12.1 jointsStandard Deviation 10.12
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 22)-10.2 jointsStandard Deviation 7.94
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 12)-13.2 jointsStandard Deviation 11.51
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 4)-7.9 jointsStandard Deviation 7.39
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 14)-13.0 jointsStandard Deviation 12.15
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 14)-9.6 jointsStandard Deviation 8.44
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 22)-15.2 jointsStandard Deviation 12.93
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Swollen joint count (Change at Week 6)-9.0 jointsStandard Deviation 7.92
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1Tender joint count (Change at Week 30)-15.6 jointsStandard Deviation 12.57
Secondary

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Baseline)10.2 jointsStandard Deviation 11.74
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 38)-1.3 jointsStandard Deviation 6.74
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 46)-1.6 jointsStandard Deviation 7.87
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 54)-1.7 jointsStandard Deviation 7.96
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Baseline)4.9 jointsStandard Deviation 6.46
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 38)-0.8 jointsStandard Deviation 4.19
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 46)-1.2 jointsStandard Deviation 5.2
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 54)-1.3 jointsStandard Deviation 5.52
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 46)-1.0 jointsStandard Deviation 9.32
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 46)0.0 jointsStandard Deviation 5.54
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 54)-1.7 jointsStandard Deviation 10.23
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Baseline)5.3 jointsStandard Deviation 6.57
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 38)-0.1 jointsStandard Deviation 4.9
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Baseline)10.2 jointsStandard Deviation 11.96
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 38)-0.5 jointsStandard Deviation 8.86
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 54)-0.9 jointsStandard Deviation 7.02
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 46)-0.8 jointsStandard Deviation 7.77
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 38)-1.0 jointsStandard Deviation 6.03
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Baseline)9.1 jointsStandard Deviation 8.89
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Tender joint count (Change at Week 54)-0.5 jointsStandard Deviation 9.03
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 46)-0.5 jointsStandard Deviation 4.22
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 38)-0.3 jointsStandard Deviation 3.93
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Baseline)4.6 jointsStandard Deviation 5.35
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2Swollen joint count (Change at Week 54)-0.7 jointsStandard Deviation 4.1
Secondary

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Baseline)7.5 jointsStandard Deviation 9.51
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 62)-0.7 jointsStandard Deviation 5.88
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 70)-1.4 jointsStandard Deviation 6.32
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 78)-1.7 jointsStandard Deviation 6.57
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Baseline)3.4 jointsStandard Deviation 5.72
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 62)-0.3 jointsStandard Deviation 3.76
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 70)-0.7 jointsStandard Deviation 4.6
Period 1: PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 78)-0.9 jointsStandard Deviation 4.63
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 70)-0.6 jointsStandard Deviation 5.14
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 70)-0.4 jointsStandard Deviation 4.12
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 78)-1.0 jointsStandard Deviation 5.82
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Baseline)4.1 jointsStandard Deviation 5.16
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 62)0.0 jointsStandard Deviation 4.41
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Baseline)7.5 jointsStandard Deviation 9.21
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 62)0.3 jointsStandard Deviation 5.21
Period 1: Infliximab-EU Remicade (INX)Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 78)-0.5 jointsStandard Deviation 4
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 70)-1.0 jointsStandard Deviation 5.51
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 62)-0.8 jointsStandard Deviation 5.18
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Baseline)7.4 jointsStandard Deviation 7.99
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Tender joint count (Change at Week 78)-1.4 jointsStandard Deviation 6.63
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 70)-0.5 jointsStandard Deviation 2.48
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 62)-0.3 jointsStandard Deviation 2.72
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Baseline)3.5 jointsStandard Deviation 4.28
Period 2: INX/PF-06438179Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3Swollen joint count (Change at Week 78)-0.2 jointsStandard Deviation 3.14
Secondary

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 2)2 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 4)10 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 6)12 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 12)28 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 14)27 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 22)25 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 30, pre-dose)30 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 2)9 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 4)28 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 6)40 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 12)52 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 14)53 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 22)58 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 30, pre-dose)62 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 12)44 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 2)3 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 2)17 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 4)11 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 22)50 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 6)10 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 4)32 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 12)17 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 14)43 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 14)22 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 6)35 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 22)20 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1DAS remission (Week 30, pre-dose)54 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1ACR/EULAR remission (Week 30, pre-dose)23 participants
Secondary

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 38)29 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 46)39 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 54, pre-dose)42 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 38)74 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 46)76 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 54, pre-dose)79 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 54, pre-dose)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 38)15 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 38)26 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 46)30 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 46)15 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 54, pre-dose)18 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 46)7 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 54, pre-dose)13 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 54, pre-dose)29 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 38)25 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2ACR/EULAR remission (Week 38)8 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2DAS remission (Week 46)21 participants
Secondary

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 62)46 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 70)50 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 78)57 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 62)85 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 70)82 participants
Period 1: PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 78)94 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 78)39 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 62)19 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 62)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 70)40 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 70)18 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 78)19 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 70)19 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 78)18 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 78)41 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 62)34 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3ACR/EULAR remission (Week 62)20 participants
Period 2: INX/PF-06438179Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3DAS remission (Week 70)34 participants
Secondary

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

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 2105 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 4170 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 6187 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 12210 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1week 22205 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 30 (pre-dose)197 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1week 22213 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 2121 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 12214 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 4190 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 30 (pre-dose)209 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1Week 6201 participants
Secondary

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 46199 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 38206 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 54 (pre-dose)199 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 4698 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 38101 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 54 (pre-dose)92 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 38110 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 54 (pre-dose)101 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2Week 4699 participants
Secondary

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 70199 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 62199 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 78192 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 7087 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 6289 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 7886 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 62103 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 7898 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3Week 7098 participants
Secondary

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

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number 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 1ACR50 (Week 2)24 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 4)72 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 6)88 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 12)95 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 14)116 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 22)126 participants
Period 1: PF-06438179Number 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 1ACR50 (Week 30, pre-dose)125 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 2)6 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 4)22 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 6)33 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 12)46 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 14)56 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 22)56 participants
Period 1: PF-06438179Number 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 1ACR70 (Week 30, pre-dose)67 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 12)40 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 2)24 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 2)6 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 4)59 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 22)45 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 6)80 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 4)13 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 12)101 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 14)33 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 14)108 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 6)16 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 22)116 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR70 (Week 30, pre-dose)58 participants
Period 1: Infliximab-EU Remicade (INX)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 1ACR50 (Week 30, pre-dose)132 participants
Secondary

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

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 38)132 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 46)135 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 54, pre-dose)135 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 38)77 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 46)75 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 54, pre-dose)82 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 54, pre-dose)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 38)58 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 38)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 46)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 46)55 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 54, pre-dose)61 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 46)63 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 54, pre-dose)65 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 54, pre-dose)35 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 38)38 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR50 (Week 38)75 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2ACR70 (Week 46)33 participants
Secondary

Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 62)132 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 70)142 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 78)150 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 62)88 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 70)92 participants
Period 1: PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 78)98 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 78)33 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 62)59 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 62)31 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 70)35 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 70)61 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 78)57 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 70)67 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 78)73 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 78)44 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 62)41 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR50 (Week 62)71 participants
Period 2: INX/PF-06438179Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3ACR70 (Week 70)44 participants
Secondary

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (good response)24 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (moderate response)172 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (no response)121 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (good response)61 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (moderate response)162 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (no response)89 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (good response)65 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (moderate response)168 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (no response)79 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (good response)90 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (moderate response)149 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (no response)71 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (good response)97 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (moderate response)137 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (no response)76 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (good response)103 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (moderate response)125 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (no response)73 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (good response)101 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (moderate response)133 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (no response)58 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (moderate response)162 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (good response)34 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (good response)94 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (moderate response)161 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (no response)66 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 2 (no response)129 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (moderate response)156 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (good response)56 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (good response)82 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (moderate response)172 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (no response)48 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 4 (no response)87 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (moderate response)155 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (good response)64 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (no response)55 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (moderate response)181 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 14 (no response)77 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 6 (no response)74 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 30 (moderate response)155 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 12 (good response)88 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1Week 22 (good response)96 participants
Secondary

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2

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)

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (good response)107 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (no response)29 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (no response)33 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (moderate response)126 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (good response)110 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (moderate response)109 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (no response)34 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (moderate response)132 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (good response)118 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (moderate response)64 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (good response)51 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (moderate response)62 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (no response)28 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (good response)46 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (no response)28 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (good response)53 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (moderate response)56 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (no response)20 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (no response)25 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (good response)49 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (good response)50 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 38 (moderate response)66 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (no response)16 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (moderate response)67 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (good response)49 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 54 (moderate response)62 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2Week 46 (no response)17 participants
Secondary

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (good response)133 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (good response)122 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (moderate response)102 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (no response)25 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (good response)127 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (moderate response)92 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (no response)25 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (moderate response)84 participants
Period 1: PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (no response)22 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (moderate response)48 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (good response)58 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (good response)50 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (moderate response)45 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (good response)56 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (moderate response)56 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (no response)15 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (no response)11 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (no response)17 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (no response)15 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (good response)52 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (moderate response)53 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 70 (moderate response)54 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (no response)8 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (no response)13 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (good response)57 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 78 (good response)57 participants
Period 2: INX/PF-06438179Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3Week 62 (moderate response)54 participants
Secondary

Number of Participants With Laboratory Abnormalities: Period 1

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

Population: 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.

ArmMeasureValue (NUMBER)
Period 1: PF-06438179Number of Participants With Laboratory Abnormalities: Period 1245 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Laboratory Abnormalities: Period 1237 participants
Secondary

Number of Participants With Laboratory Abnormalities: Period 2

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

Population: 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.

ArmMeasureValue (NUMBER)
Period 1: PF-06438179Number of Participants With Laboratory Abnormalities: Period 2154 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Laboratory Abnormalities: Period 283 participants
Period 2: INX/PF-06438179Number of Participants With Laboratory Abnormalities: Period 263 participants
Secondary

Number of Participants With Laboratory Abnormalities: Period 3

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

Population: 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.

ArmMeasureValue (NUMBER)
Period 1: PF-06438179Number of Participants With Laboratory Abnormalities: Period 3127 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Laboratory Abnormalities: Period 372 participants
Period 2: INX/PF-06438179Number of Participants With Laboratory Abnormalities: Period 361 participants
Secondary

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1ADA157 participants
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1NAb124 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1ADA167 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1NAb143 participants
Secondary

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2ADA146 participants
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2NAb118 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2ADA86 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2NAb73 participants
Period 2: INX/PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2ADA83 participants
Period 2: INX/PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2NAb65 participants
Secondary

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3ADA119 participants
Period 1: PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3NAb105 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3ADA66 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3NAb58 participants
Period 2: INX/PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3NAb60 participants
Period 2: INX/PF-06438179Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3ADA72 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 3)34 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 4)1 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 5)2 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 3)34 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 4)6 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1TEAEs (Grade 5)1 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 5)1 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 4)3 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 3)17 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 4)3 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 3)10 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 5)0 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 3)6 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 5)0 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2TEAEs (Grade 4)0 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 4)1 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 3)4 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 5)0 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 4)0 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 3)3 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 5)0 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 3)7 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 5)0 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3TEAEs (Grade 4)0 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1TEAEs185 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1SAEs16 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1Treatment related TEAEs81 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1Treatment related SAEs4 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1Treatment related SAEs4 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1TEAEs176 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1Treatment related TEAEs75 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1SAEs20 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2TEAEs103 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2SAEs13 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related TEAEs32 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related SAEs2 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related SAEs5 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2TEAEs48 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related TEAEs20 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2SAEs11 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related SAEs0 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2SAEs4 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2Treatment related TEAEs16 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2TEAEs54 participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

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

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

ArmMeasureGroupValue (NUMBER)
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3TEAEs73 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3SAEs3 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related TEAEs22 participants
Period 1: PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related SAEs0 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related SAEs1 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3TEAEs38 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related TEAEs10 participants
Period 1: Infliximab-EU Remicade (INX)Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3SAEs3 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related SAEs3 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3SAEs6 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3Treatment related TEAEs8 participants
Period 2: INX/PF-06438179Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3TEAEs37 participants
Secondary

Serum Concentration Versus Time Summary: Period 1

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

Population: 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.

ArmMeasureGroupValue (MEDIAN)Dispersion
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 1 (2 hours)65310 nanograms/millilitersStandard Deviation 24920
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 99 (0 hours)3547 nanograms/millilitersStandard Deviation 9559.2
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 29 (336 hours)23640 nanograms/millilitersStandard Deviation 12357
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 99 (2 hours)76030 nanograms/millilitersStandard Deviation 39407
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 15 (0 hours)17350 nanograms/millilitersStandard Deviation 8391.4
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 155 (0 hours)2051 nanograms/millilitersStandard Deviation 3440.9
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 43 (0 hours)11440 nanograms/millilitersStandard Deviation 10101
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 211 (0 hours)1781 nanograms/millilitersStandard Deviation 2765.2
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 1Day 1 (0 hours)1635 nanograms/millilitersStandard Deviation 11163
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 211 (0 hours)2112 nanograms/millilitersStandard Deviation 11703
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 1 (0 hours)656.2 nanograms/millilitersStandard Deviation 6583.8
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 1 (2 hours)62220 nanograms/millilitersStandard Deviation 22129
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 15 (0 hours)16690 nanograms/millilitersStandard Deviation 8002.7
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 29 (336 hours)21570 nanograms/millilitersStandard Deviation 10986
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 43 (0 hours)10100 nanograms/millilitersStandard Deviation 7721.7
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 99 (0 hours)2559 nanograms/millilitersStandard Deviation 6360.3
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 99 (2 hours)73350 nanograms/millilitersStandard Deviation 41410
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 1Day 155 (0 hours)1566 nanograms/millilitersStandard Deviation 2321.4
Secondary

Serum Concentration Versus Time Summary: Period 2

Time frame: Pre dose on Day 211, 267, 379 and 547

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 2Day 211 (0 hours)1801 nanograms/millilitersStandard Deviation 2773.4
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 2Day 267 (0 hours)1855 nanograms/millilitersStandard Deviation 2871.7
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 2Day 379 (0 hours)2075 nanograms/millilitersStandard Deviation 4054.6
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 2Day 547 (0 hours)499.6 nanograms/millilitersStandard Deviation 1373
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 2Day 547 (0 hours)212.7 nanograms/millilitersStandard Deviation 405.18
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 2Day 211 (0 hours)1083 nanograms/millilitersStandard Deviation 1763.6
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 2Day 379 (0 hours)1823 nanograms/millilitersStandard Deviation 6110.8
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 2Day 267 (0 hours)1208 nanograms/millilitersStandard Deviation 1926.5
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 2Day 547 (0 hours)3305 nanograms/millilitersStandard Deviation 8429.5
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 2Day 267 (0 hours)1620 nanograms/millilitersStandard Deviation 2413.7
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 2Day 379 (0 hours)1734 nanograms/millilitersStandard Deviation 2725.2
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 2Day 211 (0 hours)1819 nanograms/millilitersStandard Deviation 2393.5
Secondary

Serum Concentration Versus Time Summary: Period 3

Time frame: Pre dose on Day 379, 435 and 547

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 3Day 5471707 nanograms/millilitersStandard Deviation 2512.9
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 3Day 379 (0 hours)2078 nanograms/millilitersStandard Deviation 4044
Period 1: PF-06438179Serum Concentration Versus Time Summary: Period 3Day 435 (0 hours)1913 nanograms/millilitersStandard Deviation 2838
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 3Day 5471663 nanograms/millilitersStandard Deviation 5305.7
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 3Day 435 (0 hours)1388 nanograms/millilitersStandard Deviation 2387.4
Period 1: Infliximab-EU Remicade (INX)Serum Concentration Versus Time Summary: Period 3Day 379 (0 hours)1823 nanograms/millilitersStandard Deviation 6110.8
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 3Day 5471482 nanograms/millilitersStandard Deviation 2441.6
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 3Day 435 (0 hours)1572 nanograms/millilitersStandard Deviation 2543.4
Period 2: INX/PF-06438179Serum Concentration Versus Time Summary: Period 3Day 379 (0 hours)1734 nanograms/millilitersStandard Deviation 2725.2

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026