Rheumatoid Arthritis
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 | Week 14 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 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 3 | Week 62, 70 and 78 | 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 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 | Week 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 2 | Week 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 3 | Week 62, 70 and 78 | 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. |
| 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 | Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30 | 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. |
| Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | Baseline (Week 30 pre-dose), Week 38, 46 and 54 | 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. |
| Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | Baseline (Week 54 pre-dose), Week 62, 70 and 78 | 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. |
| Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | Week 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 2 | Week 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 3 | Week 62, 70 and 78 | 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 With European League Against Rheumatism (EULAR) Response: Period 1 | Week 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 2 | Week 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 3 | Week 62, 70 and Week 78 | 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. |
| Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 | Baseline (Day 1) up to Week 30 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | Baseline (Week 30 pre-dose) up to Week 54 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | Baseline (Week 54 pre-dose) up to Week 78 | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 | Baseline (Day 1) up to Week 30 | 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. |
| 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 | Week 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 3 | Baseline (Week 54 pre-dose) up to Week 78 | 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. |
| Number of Participants With Laboratory Abnormalities: Period 1 | Baseline (Day 1) up to Week 30 | 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. |
| Number of Participants With Laboratory Abnormalities: Period 2 | Baseline (Week 30 pre-dose) up to Week 54 | 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. |
| Number of Participants With Laboratory Abnormalities: Period 3 | Baseline (Week 54 pre-dose) up to Week 78 | 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. |
| Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Baseline (Week 30 pre-dose), Week 38, 46 and Week 54 | 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. |
| Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Baseline (Week 54 pre-dose), Week 62, 70 and 78 | 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. |
| 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 | Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30 | 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. |
| 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 | Baseline (Week 30 pre-dose), Week 38, 46 and 54 | 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. |
| 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 | Baseline (Week 54 pre-dose), Week 62, 70 and 78 | 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. |
| Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Baseline (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 2 | Baseline (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 3 | Baseline (Week 54 pre-dose), Week 62, 70 and 78 | — |
| Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 | Baseline (Day 1) up to Week 30 | ADA 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 2 | Baseline (Week 30 pre-dose) up to Week 54 | ADA 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 3 | Baseline (Week 54 pre-dose) up to Week 78 | ADA 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 1 | 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 | — |
| Serum Concentration Versus Time Summary: Period 2 | Pre dose on Day 211, 267, 379 and 547 | — |
| Serum Concentration Versus Time Summary: Period 3 | Pre dose on Day 379, 435 and 547 | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | Baseline (Week 30 pre-dose) up to Week 54 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 650 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: First Dose-Week 30 (Pre-dose) | Adverse Event | 18 | 20 |
| Period 1: First Dose-Week 30 (Pre-dose) | Death | 2 | 2 |
| Period 1: First Dose-Week 30 (Pre-dose) | Insufficient clinical response | 0 | 7 |
| Period 1: First Dose-Week 30 (Pre-dose) | Lost to Follow-up | 0 | 1 |
| Period 1: First Dose-Week 30 (Pre-dose) | Non-compliance with study treatment | 1 | 0 |
| Period 1: First Dose-Week 30 (Pre-dose) | Other | 4 | 0 |
| Period 1: First Dose-Week 30 (Pre-dose) | Pregnancy | 2 | 0 |
| Period 1: First Dose-Week 30 (Pre-dose) | Protocol Violation | 5 | 1 |
| Period 1: First Dose-Week 30 (Pre-dose) | Randomized but not treated | 1 | 0 |
| Period 1: First Dose-Week 30 (Pre-dose) | Withdrawal by Subject | 11 | 9 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Adverse Event | 22 | 9 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Death | 1 | 0 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Insufficient clinical response | 9 | 3 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Lost to Follow-up | 1 | 1 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Non-compliance with study treatment | 1 | 0 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Other | 3 | 0 |
| Period 2: Week30 Dosing-Week54(Pre-dose) | Withdrawal by Subject | 6 | 4 |
| Period 3: Week 54 Dosing-Week 78 Visit | Adverse Event | 14 | 0 |
| Period 3: Week 54 Dosing-Week 78 Visit | Insufficient clinical response | 3 | 0 |
| Period 3: Week 54 Dosing-Week 78 Visit | Non-compliance with study treatment | 1 | 0 |
| Period 3: Week 54 Dosing-Week 78 Visit | Other | 4 | 0 |
| Period 3: Week 54 Dosing-Week 78 Visit | Withdrawal by Subject | 9 | 0 |
Baseline characteristics
| Characteristic | PF-06438179 | Infliximab-EU Remicade (INX) | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 13.3 | 52.8 years STANDARD_DEVIATION 12.9 | 52.8 years STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 258 Participants | 264 Participants | 522 Participants |
| Sex: Female, Male Male | 66 Participants | 62 Participants | 128 Participants |
Adverse events
| Event type | EG000 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 / 323 | 35 / 326 | 8 / 280 | 11 / 143 | 6 / 143 | 0 / 253 | 0 / 126 | 0 / 126 |
| serious Total, serious adverse events | 16 / 323 | 20 / 326 | 13 / 280 | 11 / 143 | 4 / 143 | 3 / 253 | 3 / 126 | 6 / 126 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 | 198 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 | 207 participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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-CRP (Baseline) | 5.950 units on a scale | Standard Deviation 0.9577 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 2) | -1.213 units on a scale | Standard Deviation 0.928 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 4) | -1.596 units on a scale | Standard Deviation 1.1259 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 6) | -1.710 units on a scale | Standard Deviation 1.1959 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 12) | -1.898 units on a scale | Standard Deviation 1.3516 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 14) | -1.901 units on a scale | Standard Deviation 1.4125 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 22) | -2.005 units on a scale | Standard Deviation 1.4236 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 30) | -2.140 units on a scale | Standard Deviation 1.4197 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Baseline) | 1.623 units on a scale | Standard Deviation 0.6485 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 2) | -0.317 units on a scale | Standard Deviation 0.41 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 4) | -0.472 units on a scale | Standard Deviation 0.4728 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 6) | -0.496 units on a scale | Standard Deviation 0.5505 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 12) | -0.535 units on a scale | Standard Deviation 0.5795 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 14) | -0.572 units on a scale | Standard Deviation 0.591 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 22) | -0.588 units on a scale | Standard Deviation 0.6061 |
| Period 1: PF-06438179 | 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 | HAQ-DI (Change at Week 30) | -0.621 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 30) | -0.612 units on a scale | Standard 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 1 | DAS28-CRP (Baseline) | 5.983 units on a scale | Standard 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 1 | HAQ-DI (Baseline) | 1.586 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 2) | -1.241 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 12) | -0.524 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 4) | -1.605 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 2) | -0.328 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 6) | -1.750 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 22) | -0.569 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 12) | -1.885 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 4) | -0.477 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 14) | -1.827 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 14) | -0.531 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 22) | -2.002 units on a scale | Standard 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 1 | HAQ-DI (Change at Week 6) | -0.520 units on a scale | Standard 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 1 | DAS28-CRP (Change at Week 30) | -2.117 units on a scale | Standard Deviation 1.2738 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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-CRP (Baseline) | 3.765 units on a scale | Standard Deviation 1.4629 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 38) | -0.181 units on a scale | Standard Deviation 0.9574 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 46) | -0.228 units on a scale | Standard Deviation 1.0453 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 54) | -0.275 units on a scale | Standard Deviation 1.1338 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Baseline) | 0.978 units on a scale | Standard Deviation 0.7042 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 38) | -0.019 units on a scale | Standard Deviation 0.3328 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 46) | -0.043 units on a scale | Standard Deviation 0.3774 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 54) | -0.026 units on a scale | Standard 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 2 | DAS28-CRP (Change at Week 46) | 0.048 units on a scale | Standard 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 2 | HAQ-DI (Change at Week 46) | 0.014 units on a scale | Standard 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 2 | DAS28-CRP (Change at Week 54) | -0.109 units on a scale | Standard 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 2 | HAQ-DI (Change at Baseline) | 0.913 units on a scale | Standard 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 2 | HAQ-DI (Change at Week 38) | 0.019 units on a scale | Standard 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 2 | DAS28-CRP (Baseline) | 3.819 units on a scale | Standard 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 2 | DAS28-CRP (Change at Week 38) | 0.036 units on a scale | Standard 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 2 | HAQ-DI (Change at Week 54) | 0.017 units on a scale | Standard Deviation 0.4399 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 46) | -0.017 units on a scale | Standard Deviation 1.0692 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 38) | -0.059 units on a scale | Standard Deviation 0.8756 |
| Period 2: INX/PF-06438179 | 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-CRP (Baseline) | 3.781 units on a scale | Standard Deviation 1.2547 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 54) | -0.057 units on a scale | Standard Deviation 1.2339 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 46) | 0.035 units on a scale | Standard Deviation 0.4325 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 38) | 0.007 units on a scale | Standard Deviation 0.3688 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Baseline) | 0.951 units on a scale | Standard Deviation 0.6481 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 | HAQ-DI (Change at Week 54) | -0.044 units on a scale | Standard Deviation 0.3881 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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-CRP (Baseline) | 3.386 units on a scale | Standard Deviation 1.3229 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 62) | -0.072 units on a scale | Standard Deviation 0.915 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 70) | -0.157 units on a scale | Standard Deviation 0.9502 |
| Period 1: PF-06438179 | 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-CRP (Change at Week 78) | -0.236 units on a scale | Standard Deviation 1.0361 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Baseline) | 0.905 units on a scale | Standard Deviation 0.705 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 62) | -0.024 units on a scale | Standard Deviation 0.3126 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 70) | -0.046 units on a scale | Standard Deviation 0.3502 |
| Period 1: PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 78) | -0.079 units on a scale | Standard 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 3 | DAS28-CRP (Change at Week 70) | -0.168 units on a scale | Standard 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 3 | HAQ-DI (Change at Week 70) | -0.027 units on a scale | Standard 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 3 | DAS28-CRP (Change at Week 78) | -0.269 units on a scale | Standard 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 3 | HAQ-DI (Baseline) | 0.893 units on a scale | Standard 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 3 | HAQ-DI (Change at Week 62) | 0.021 units on a scale | Standard 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 3 | DAS28-CRP (Baseline) | 3.561 units on a scale | Standard 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 3 | DAS28-CRP (Change at Week 62) | -0.004 units on a scale | Standard 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 3 | HAQ-DI (Change at Week 78) | -0.022 units on a scale | Standard Deviation 0.3521 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 70) | -0.162 units on a scale | Standard Deviation 0.797 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 62) | -0.154 units on a scale | Standard Deviation 0.684 |
| Period 2: INX/PF-06438179 | 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-CRP (Baseline) | 3.594 units on a scale | Standard Deviation 1.2572 |
| Period 2: INX/PF-06438179 | 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-CRP (Change at Week 78) | -0.215 units on a scale | Standard Deviation 1.0584 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 70) | 0.030 units on a scale | Standard Deviation 0.295 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 62) | 0.008 units on a scale | Standard Deviation 0.2942 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Baseline) | 0.883 units on a scale | Standard Deviation 0.6109 |
| Period 2: INX/PF-06438179 | Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 | HAQ-DI (Change at Week 78) | 0.001 units on a scale | Standard Deviation 0.38 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Baseline | 25.916 milligram/litres | Standard Deviation 24.3118 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 2 | -17.183 milligram/litres | Standard Deviation 20.8107 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 4 | -15.555 milligram/litres | Standard Deviation 19.5227 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 6 | -14.078 milligram/litres | Standard Deviation 20.4984 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 12 | -12.502 milligram/litres | Standard Deviation 23.9435 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 14 | -12.613 milligram/litres | Standard Deviation 23.2548 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 22 | -11.195 milligram/litres | Standard Deviation 24.5225 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Change at Week 30 | -12.165 milligram/litres | Standard 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 1 | Change at Week 30 | -12.390 milligram/litres | Standard 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 1 | Baseline | 25.366 milligram/litres | Standard 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 1 | Change at Week 12 | -12.525 milligram/litres | Standard 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 1 | Change at Week 2 | -16.140 milligram/litres | Standard 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 1 | Change at Week 22 | -11.422 milligram/litres | Standard 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 1 | Change at Week 4 | -13.407 milligram/litres | Standard 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 1 | Change at Week 14 | -12.392 milligram/litres | Standard 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 1 | Change at Week 6 | -13.247 milligram/litres | Standard Deviation 27.7801 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Baseline | 12.970 milligrams/litres | Standard Deviation 19.1927 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 38 | 0.496 milligrams/litres | Standard Deviation 18.7859 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 46 | 1.210 milligrams/litres | Standard Deviation 16.1727 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 54 | 0.639 milligrams/litres | Standard 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 2 | Change at Week 54 | 2.988 milligrams/litres | Standard 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 2 | Baseline | 14.427 milligrams/litres | Standard 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 2 | Change at Week 46 | 3.996 milligrams/litres | Standard 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 2 | Change at Week 38 | 1.805 milligrams/litres | Standard Deviation 19.5138 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 54 | 1.264 milligrams/litres | Standard Deviation 13.6788 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 38 | 0.093 milligrams/litres | Standard Deviation 14.8441 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Change at Week 46 | 0.798 milligrams/litres | Standard Deviation 15.7687 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 | Baseline | 10.847 milligrams/litres | Standard Deviation 14.8018 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Baseline | 13.112 milligrams/litres | Standard Deviation 21.3781 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 62 | -0.635 milligrams/litres | Standard Deviation 19.966 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 70 | -0.320 milligrams/litres | Standard Deviation 23.1234 |
| Period 1: PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 78 | -1.660 milligrams/litres | Standard 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 3 | Change at Week 78 | -3.565 milligrams/litres | Standard 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 3 | Baseline | 16.096 milligrams/litres | Standard 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 3 | Change at Week 70 | -4.199 milligrams/litres | Standard 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 3 | Change at Week 62 | -3.648 milligrams/litres | Standard Deviation 21.6177 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 78 | 0.811 milligrams/litres | Standard Deviation 14.7061 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 62 | -0.541 milligrams/litres | Standard Deviation 9.3198 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Change at Week 70 | -0.339 milligrams/litres | Standard Deviation 11.7095 |
| Period 2: INX/PF-06438179 | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 | Baseline | 11.985 milligrams/litres | Standard Deviation 13.8159 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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 (Change at week 22) | -27.844 units on a scale | Standard Deviation 27.0039 |
| Period 1: PF-06438179 | 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 (Change at Week 2) | -15.724 units on a scale | Standard Deviation 21.9589 |
| Period 1: PF-06438179 | 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 (Change at Week 4) | -21.609 units on a scale | Standard Deviation 22.3825 |
| Period 1: PF-06438179 | 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 (Change at Week 6) | -23.917 units on a scale | Standard Deviation 25.0213 |
| Period 1: PF-06438179 | 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 (Change at Week 12) | -25.364 units on a scale | Standard Deviation 25.6602 |
| Period 1: PF-06438179 | 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 (Change at Week 14) | -26.131 units on a scale | Standard Deviation 26.8712 |
| Period 1: PF-06438179 | 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 (Baseline) | 63.514 units on a scale | Standard Deviation 20.5903 |
| Period 1: PF-06438179 | 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 (Change at Week 30) | -29.150 units on a scale | Standard Deviation 27.9802 |
| Period 1: PF-06438179 | 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 | PGA (Baseline) | 65.340 units on a scale | Standard Deviation 20.7209 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 2) | -17.262 units on a scale | Standard Deviation 22.8767 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 4) | -23.393 units on a scale | Standard Deviation 23.3769 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 6) | -25.536 units on a scale | Standard Deviation 24.8041 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 12) | -26.882 units on a scale | Standard Deviation 25.327 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 14) | -27.583 units on a scale | Standard Deviation 26.7955 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 22) | -28.558 units on a scale | Standard Deviation 27.5077 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 30) | -29.186 units on a scale | Standard Deviation 28.6488 |
| Period 1: PF-06438179 | 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 | PGAA (Baseline) | 65.362 units on a scale | Standard Deviation 16.252 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 2) | -21.913 units on a scale | Standard Deviation 18.5574 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 4) | -29.724 units on a scale | Standard Deviation 19.2226 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 6) | -33.319 units on a scale | Standard Deviation 20.1143 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 12) | -34.827 units on a scale | Standard Deviation 19.8162 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 14) | -35.870 units on a scale | Standard Deviation 21.4707 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 22) | -37.542 units on a scale | Standard Deviation 20.8619 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 30) | -39.842 units on a scale | Standard 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 1 | PGAA (Change at Week 22) | -36.118 units on a scale | Standard 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 1 | PAAP (Baseline) | 63.098 units on a scale | Standard 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 1 | PGA (Change at Week 12) | -26.535 units on a scale | Standard 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 1 | PAAP (Change at Week 2) | -15.360 units on a scale | Standard 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 1 | PGAA (Change at Week 4) | -27.905 units on a scale | Standard 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 1 | PAAP (Change at Week 4) | -20.552 units on a scale | Standard 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 1 | PGA (Change at Week 14) | -25.323 units on a scale | Standard 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 1 | PAAP (Change at Week 6) | -22.797 units on a scale | Standard 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 1 | PGAA (Change at Week 14) | -34.175 units on a scale | Standard 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 1 | PAAP (Change at Week 12) | -25.829 units on a scale | Standard 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 1 | PGA (Change at Week 22) | -26.486 units on a scale | Standard 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 1 | PAAP (Change at Week 14) | -25.077 units on a scale | Standard 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 1 | PGAA (Change at Week 6) | -30.958 units on a scale | Standard 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 1 | PAAP (Change at week 22) | -25.788 units on a scale | Standard 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 1 | PGA (Change at Week 30) | -28.814 units on a scale | Standard 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 1 | PAAP (Change at Week 30) | -28.853 units on a scale | Standard 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 1 | PGAA (Change at Week 30) | -36.666 units on a scale | Standard 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 1 | PGA (Baseline) | 63.752 units on a scale | Standard 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 1 | PGAA (Baseline) | 64.126 units on a scale | Standard 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 1 | PGA (Change at Week 2) | -16.504 units on a scale | Standard 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 1 | PGAA (Change at Week 12) | -33.919 units on a scale | Standard 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 1 | PGA (Change at Week 4) | -21.355 units on a scale | Standard 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 1 | PGAA (Change at Week 2) | -20.143 units on a scale | Standard 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 1 | PGA (Change at Week 6) | -23.314 units on a scale | Standard Deviation 24.2005 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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 (Baseline) | 33.137 units on a scale | Standard Deviation 24.2922 |
| Period 1: PF-06438179 | 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 (Change at Week 38) | -0.014 units on a scale | Standard Deviation 18.7502 |
| Period 1: PF-06438179 | 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 (Change at Week 46) | -2.230 units on a scale | Standard Deviation 20.0201 |
| Period 1: PF-06438179 | 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 (Change at Week 54) | -1.416 units on a scale | Standard Deviation 20.7823 |
| Period 1: PF-06438179 | 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 | PGA (Baseline) | 35.104 units on a scale | Standard Deviation 24.8444 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 38) | -1.628 units on a scale | Standard Deviation 19.1471 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 46) | -3.171 units on a scale | Standard Deviation 20.305 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 54) | -2.929 units on a scale | Standard Deviation 20.9396 |
| Period 1: PF-06438179 | 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 | PGAA (Baseline) | 25.124 units on a scale | Standard Deviation 19.0943 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 38) | -1.254 units on a scale | Standard Deviation 12.4789 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 46) | -2.470 units on a scale | Standard Deviation 13.9135 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 54) | -2.252 units on a scale | Standard 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 2 | PGAA (Change at Week 54) | -3.398 units on a scale | Standard 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 2 | PAAP (Baseline) | 33.331 units on a scale | Standard 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 2 | PGA (Change at Week 46) | 0.558 units on a scale | Standard 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 2 | PGAA (Baseline) | 27.294 units on a scale | Standard 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 2 | PAAP (Change at Week 38) | 1.440 units on a scale | Standard 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 2 | PGA (Change at Week 38) | 1.582 units on a scale | Standard 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 2 | PGAA (Change at Week 46) | 0.625 units on a scale | Standard 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 2 | PAAP (Change at Week 46) | 1.087 units on a scale | Standard 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 2 | PGA (Change at Week 54) | -0.538 units on a scale | Standard 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 2 | PGA (Baseline) | 33.268 units on a scale | Standard 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 2 | PAAP (Change at Week 54) | -0.492 units on a scale | Standard 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 2 | PGAA (Change at Week 38) | 0.588 units on a scale | Standard Deviation 16.5232 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 54) | 1.365 units on a scale | Standard Deviation 24.8362 |
| Period 2: INX/PF-06438179 | 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 | PGA (Baseline) | 34.029 units on a scale | Standard Deviation 22.7172 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 38) | -1.852 units on a scale | Standard Deviation 15.4699 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 38) | -1.086 units on a scale | Standard Deviation 17.5787 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 46) | 0.535 units on a scale | Standard Deviation 21.3947 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 54) | 0.776 units on a scale | Standard Deviation 23.8743 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 46) | -0.700 units on a scale | Standard Deviation 18.8038 |
| Period 2: INX/PF-06438179 | 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 (Baseline) | 32.559 units on a scale | Standard Deviation 22.2702 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 38) | -0.705 units on a scale | Standard Deviation 18.9147 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Baseline) | 26.091 units on a scale | Standard Deviation 17.9503 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 46) | 2.188 units on a scale | Standard Deviation 20.7319 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 54) | -2.969 units on a scale | Standard Deviation 20.1498 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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 | PGA (Change at Week 70) | -1.764 units on a scale | Standard Deviation 18.7038 |
| Period 1: PF-06438179 | 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 (Change at Week 62) | -0.025 units on a scale | Standard Deviation 15.8259 |
| Period 1: PF-06438179 | 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 (Baseline) | 30.395 units on a scale | Standard Deviation 23.7412 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 78) | -2.217 units on a scale | Standard Deviation 15.3894 |
| Period 1: PF-06438179 | 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 (Change at Week 70) | -2.948 units on a scale | Standard Deviation 18.1105 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 62) | 0.240 units on a scale | Standard Deviation 16.2724 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 70) | -3.217 units on a scale | Standard Deviation 14.1581 |
| Period 1: PF-06438179 | 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 (Change at Week 78) | -3.552 units on a scale | Standard Deviation 18.876 |
| Period 1: PF-06438179 | 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 | PGAA (Baseline) | 21.305 units on a scale | Standard Deviation 17.6278 |
| Period 1: PF-06438179 | 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 | PGA (Change at Week 78) | -2.880 units on a scale | Standard Deviation 19.6643 |
| Period 1: PF-06438179 | 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 | PGA (Baseline) | 30.841 units on a scale | Standard Deviation 23.7807 |
| Period 1: PF-06438179 | 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 | PGAA (Change at Week 62) | -0.381 units on a scale | Standard 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 3 | PGA (Baseline) | 31.130 units on a scale | Standard 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 3 | PGAA (Change at Week 62) | 2.659 units on a scale | Standard 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 3 | PGAA (Change at Week 70) | -1.160 units on a scale | Standard 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 3 | PGAA (Change at Week 78) | 0.681 units on a scale | Standard 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 3 | PAAP (Baseline) | 31.659 units on a scale | Standard 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 3 | PGAA (Baseline) | 21.780 units on a scale | Standard 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 3 | PAAP (Change at Week 62) | 0.276 units on a scale | Standard 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 3 | PGA (Change at Week 70) | 0.101 units on a scale | Standard 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 3 | PAAP (Change at Week 70) | -0.297 units on a scale | Standard 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 3 | PGA (Change at Week 62) | 1.463 units on a scale | Standard 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 3 | PAAP (Change at Week 78) | -2.900 units on a scale | Standard 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 3 | PGA (Change at Week 78) | -2.339 units on a scale | Standard Deviation 17.0453 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 70) | -0.970 units on a scale | Standard Deviation 16.717 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 62) | -2.226 units on a scale | Standard Deviation 15.3415 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 70) | -2.093 units on a scale | Standard Deviation 16.2677 |
| Period 2: INX/PF-06438179 | 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 | PGA (Change at Week 78) | -3.758 units on a scale | Standard Deviation 19.5447 |
| Period 2: INX/PF-06438179 | 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 (Baseline) | 31.225 units on a scale | Standard Deviation 22.9366 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 62) | -1.790 units on a scale | Standard Deviation 16.674 |
| Period 2: INX/PF-06438179 | 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 | PGA (Baseline) | 32.710 units on a scale | Standard Deviation 22.6365 |
| Period 2: INX/PF-06438179 | 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 (Change at Week 78) | -3.918 units on a scale | Standard Deviation 20.9632 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Baseline) | 20.705 units on a scale | Standard Deviation 16.9587 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 62) | -0.499 units on a scale | Standard Deviation 12.9483 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 70) | -0.810 units on a scale | Standard Deviation 15.0274 |
| Period 2: INX/PF-06438179 | 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 | PGAA (Change at Week 78) | -0.159 units on a scale | Standard Deviation 17.2024 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | 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 (Baseline) | 24.7 joints | Standard Deviation 13.9 |
| Period 1: PF-06438179 | 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 (Change at Week 2) | -5.9 joints | Standard Deviation 8.78 |
| Period 1: PF-06438179 | 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 (Change at Week 4) | -9.5 joints | Standard Deviation 10.02 |
| Period 1: PF-06438179 | 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 (Change at Week 6) | -10.6 joints | Standard Deviation 11.17 |
| Period 1: PF-06438179 | 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 (Change at Week 12) | -12.1 joints | Standard Deviation 11.84 |
| Period 1: PF-06438179 | 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 (Change at Week 14) | -11.8 joints | Standard Deviation 12.5 |
| Period 1: PF-06438179 | 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 (Change at Week 22) | -13.2 joints | Standard Deviation 12.62 |
| Period 1: PF-06438179 | 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 (Change at Week 30) | -14.4 joints | Standard Deviation 13.19 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Baseline) | 16.1 joints | Standard Deviation 9.44 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 2) | -5.5 joints | Standard Deviation 6.89 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 4) | -7.8 joints | Standard Deviation 7.75 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 6) | -8.6 joints | Standard Deviation 7.99 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 12) | -9.6 joints | Standard Deviation 8.61 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 14) | -9.3 joints | Standard Deviation 8.87 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 22) | -10.5 joints | Standard Deviation 8.77 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 | Swollen joint count (Change at Week 30) | -11.0 joints | Standard 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 1 | Swollen joint count (Change at Week 30) | -10.7 joints | Standard 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 1 | Tender joint count (Baseline) | 25.8 joints | Standard 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 1 | Swollen joint count (Baseline) | 16.3 joints | Standard 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 1 | Tender joint count (Change at Week 2) | -7.5 joints | Standard 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 1 | Swollen joint count (Change at Week 12) | -9.6 joints | Standard 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 1 | Tender joint count (Change at Week 4) | -10.4 joints | Standard 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 1 | Swollen joint count (Change at Week 2) | -5.7 joints | Standard 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 1 | Tender joint count (Change at Week 6) | -12.1 joints | Standard 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 1 | Swollen joint count (Change at Week 22) | -10.2 joints | Standard 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 1 | Tender joint count (Change at Week 12) | -13.2 joints | Standard 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 1 | Swollen joint count (Change at Week 4) | -7.9 joints | Standard 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 1 | Tender joint count (Change at Week 14) | -13.0 joints | Standard 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 1 | Swollen joint count (Change at Week 14) | -9.6 joints | Standard 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 1 | Tender joint count (Change at Week 22) | -15.2 joints | Standard 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 1 | Swollen joint count (Change at Week 6) | -9.0 joints | Standard 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 1 | Tender joint count (Change at Week 30) | -15.6 joints | Standard Deviation 12.57 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Baseline) | 10.2 joints | Standard Deviation 11.74 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 38) | -1.3 joints | Standard Deviation 6.74 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 46) | -1.6 joints | Standard Deviation 7.87 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 54) | -1.7 joints | Standard Deviation 7.96 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Baseline) | 4.9 joints | Standard Deviation 6.46 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 38) | -0.8 joints | Standard Deviation 4.19 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 46) | -1.2 joints | Standard Deviation 5.2 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 54) | -1.3 joints | Standard 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 2 | Tender joint count (Change at Week 46) | -1.0 joints | Standard 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 2 | Swollen joint count (Change at Week 46) | 0.0 joints | Standard 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 2 | Tender joint count (Change at Week 54) | -1.7 joints | Standard 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 2 | Swollen joint count (Baseline) | 5.3 joints | Standard 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 2 | Swollen joint count (Change at Week 38) | -0.1 joints | Standard 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 2 | Tender joint count (Baseline) | 10.2 joints | Standard 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 2 | Tender joint count (Change at Week 38) | -0.5 joints | Standard 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 2 | Swollen joint count (Change at Week 54) | -0.9 joints | Standard Deviation 7.02 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 46) | -0.8 joints | Standard Deviation 7.77 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 38) | -1.0 joints | Standard Deviation 6.03 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Baseline) | 9.1 joints | Standard Deviation 8.89 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Tender joint count (Change at Week 54) | -0.5 joints | Standard Deviation 9.03 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 46) | -0.5 joints | Standard Deviation 4.22 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 38) | -0.3 joints | Standard Deviation 3.93 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Baseline) | 4.6 joints | Standard Deviation 5.35 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 | Swollen joint count (Change at Week 54) | -0.7 joints | Standard Deviation 4.1 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Baseline) | 7.5 joints | Standard Deviation 9.51 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 62) | -0.7 joints | Standard Deviation 5.88 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 70) | -1.4 joints | Standard Deviation 6.32 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 78) | -1.7 joints | Standard Deviation 6.57 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Baseline) | 3.4 joints | Standard Deviation 5.72 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 62) | -0.3 joints | Standard Deviation 3.76 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 70) | -0.7 joints | Standard Deviation 4.6 |
| Period 1: PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 78) | -0.9 joints | Standard 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 3 | Tender joint count (Change at Week 70) | -0.6 joints | Standard 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 3 | Swollen joint count (Change at Week 70) | -0.4 joints | Standard 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 3 | Tender joint count (Change at Week 78) | -1.0 joints | Standard 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 3 | Swollen joint count (Baseline) | 4.1 joints | Standard 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 3 | Swollen joint count (Change at Week 62) | 0.0 joints | Standard 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 3 | Tender joint count (Baseline) | 7.5 joints | Standard 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 3 | Tender joint count (Change at Week 62) | 0.3 joints | Standard 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 3 | Swollen joint count (Change at Week 78) | -0.5 joints | Standard Deviation 4 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 70) | -1.0 joints | Standard Deviation 5.51 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 62) | -0.8 joints | Standard Deviation 5.18 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Baseline) | 7.4 joints | Standard Deviation 7.99 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Tender joint count (Change at Week 78) | -1.4 joints | Standard Deviation 6.63 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 70) | -0.5 joints | Standard Deviation 2.48 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 62) | -0.3 joints | Standard Deviation 2.72 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Baseline) | 3.5 joints | Standard Deviation 4.28 |
| Period 2: INX/PF-06438179 | Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 | Swollen joint count (Change at Week 78) | -0.2 joints | Standard Deviation 3.14 |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 (Week 2) | 2 participants |
| Period 1: PF-06438179 | 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 (Week 4) | 10 participants |
| Period 1: PF-06438179 | 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 (Week 6) | 12 participants |
| Period 1: PF-06438179 | 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 (Week 12) | 28 participants |
| Period 1: PF-06438179 | 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 (Week 14) | 27 participants |
| Period 1: PF-06438179 | 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 (Week 22) | 25 participants |
| Period 1: PF-06438179 | 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 (Week 30, pre-dose) | 30 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 2) | 9 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 4) | 28 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 6) | 40 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 12) | 52 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 14) | 53 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS remission (Week 22) | 58 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 | DAS 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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/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 1 | DAS 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 1 | ACR/EULAR remission (Week 30, pre-dose) | 23 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 (Week 38) | 29 participants |
| Period 1: PF-06438179 | 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 (Week 46) | 39 participants |
| Period 1: PF-06438179 | 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 (Week 54, pre-dose) | 42 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS remission (Week 38) | 74 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS remission (Week 46) | 76 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS 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 2 | DAS 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 2 | ACR/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 2 | DAS 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 2 | DAS 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 2 | ACR/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 2 | ACR/EULAR remission (Week 54, pre-dose) | 18 participants |
| Period 2: INX/PF-06438179 | 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 (Week 46) | 7 participants |
| Period 2: INX/PF-06438179 | 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 (Week 54, pre-dose) | 13 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS remission (Week 54, pre-dose) | 29 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS remission (Week 38) | 25 participants |
| Period 2: INX/PF-06438179 | 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 (Week 38) | 8 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 | DAS remission (Week 46) | 21 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 (Week 62) | 46 participants |
| Period 1: PF-06438179 | 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 (Week 70) | 50 participants |
| Period 1: PF-06438179 | 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 (Week 78) | 57 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS remission (Week 62) | 85 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS remission (Week 70) | 82 participants |
| Period 1: PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS 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 3 | DAS 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 3 | ACR/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 3 | DAS 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 3 | DAS 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 3 | ACR/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 3 | ACR/EULAR remission (Week 78) | 19 participants |
| Period 2: INX/PF-06438179 | 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 (Week 70) | 19 participants |
| Period 2: INX/PF-06438179 | 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 (Week 78) | 18 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS remission (Week 78) | 41 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS remission (Week 62) | 34 participants |
| Period 2: INX/PF-06438179 | 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 (Week 62) | 20 participants |
| Period 2: INX/PF-06438179 | Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 | DAS remission (Week 70) | 34 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 | Week 2 | 105 participants |
| Period 1: PF-06438179 | 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 | Week 4 | 170 participants |
| Period 1: PF-06438179 | 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 | Week 6 | 187 participants |
| Period 1: PF-06438179 | 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 | Week 12 | 210 participants |
| Period 1: PF-06438179 | 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 | week 22 | 205 participants |
| Period 1: PF-06438179 | 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 | Week 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 1 | week 22 | 213 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 1 | Week 2 | 121 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 1 | Week 12 | 214 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 1 | Week 4 | 190 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 1 | Week 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 1 | Week 6 | 201 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 46 | 199 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 38 | 206 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 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 2 | Week 46 | 98 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 2 | Week 38 | 101 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 2 | Week 54 (pre-dose) | 92 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 38 | 110 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 54 (pre-dose) | 101 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 | Week 46 | 99 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 70 | 199 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 62 | 199 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 78 | 192 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 3 | Week 70 | 87 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 3 | Week 62 | 89 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 3 | Week 78 | 86 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 62 | 103 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 78 | 98 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 | Week 70 | 98 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 (Week 2) | 24 participants |
| Period 1: PF-06438179 | 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 (Week 4) | 72 participants |
| Period 1: PF-06438179 | 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 (Week 6) | 88 participants |
| Period 1: PF-06438179 | 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 (Week 12) | 95 participants |
| Period 1: PF-06438179 | 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 (Week 14) | 116 participants |
| Period 1: PF-06438179 | 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 (Week 22) | 126 participants |
| Period 1: PF-06438179 | 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 (Week 30, pre-dose) | 125 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 2) | 6 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 4) | 22 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 6) | 33 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 12) | 46 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 14) | 56 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 22) | 56 participants |
| Period 1: PF-06438179 | 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 | ACR70 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (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 1 | ACR70 (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 1 | ACR50 (Week 30, pre-dose) | 132 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | 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 (Week 38) | 132 participants |
| Period 1: PF-06438179 | 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 (Week 46) | 135 participants |
| Period 1: PF-06438179 | 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 (Week 54, pre-dose) | 135 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 38) | 77 participants |
| Period 1: PF-06438179 | 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 | ACR70 (Week 46) | 75 participants |
| Period 1: PF-06438179 | 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 | ACR70 (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 2 | ACR70 (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 2 | ACR50 (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 2 | ACR70 (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 2 | ACR70 (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 2 | ACR50 (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 2 | ACR50 (Week 54, pre-dose) | 61 participants |
| Period 2: INX/PF-06438179 | 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 (Week 46) | 63 participants |
| Period 2: INX/PF-06438179 | 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 (Week 54, pre-dose) | 65 participants |
| Period 2: INX/PF-06438179 | 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 | ACR70 (Week 54, pre-dose) | 35 participants |
| Period 2: INX/PF-06438179 | 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 | ACR70 (Week 38) | 38 participants |
| Period 2: INX/PF-06438179 | 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 (Week 38) | 75 participants |
| Period 2: INX/PF-06438179 | 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 | ACR70 (Week 46) | 33 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 62) | 132 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 70) | 142 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 78) | 150 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (Week 62) | 88 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (Week 70) | 92 participants |
| Period 1: PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (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 3 | ACR70 (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 3 | ACR50 (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 3 | ACR70 (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 3 | ACR70 (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 3 | ACR50 (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 3 | ACR50 (Week 78) | 57 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 70) | 67 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 78) | 73 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (Week 78) | 44 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (Week 62) | 41 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR50 (Week 62) | 71 participants |
| Period 2: INX/PF-06438179 | Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 | ACR70 (Week 70) | 44 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (good response) | 24 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (moderate response) | 172 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (no response) | 121 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (good response) | 61 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (moderate response) | 162 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (no response) | 89 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (good response) | 65 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (moderate response) | 168 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (no response) | 79 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (good response) | 90 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (moderate response) | 149 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (no response) | 71 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (good response) | 97 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (moderate response) | 137 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (no response) | 76 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (good response) | 103 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (moderate response) | 125 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (no response) | 73 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (good response) | 101 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (moderate response) | 133 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (no response) | 58 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (moderate response) | 162 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (good response) | 34 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (good response) | 94 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (moderate response) | 161 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (no response) | 66 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 2 (no response) | 129 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (moderate response) | 156 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (good response) | 56 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (good response) | 82 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (moderate response) | 172 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (no response) | 48 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 4 (no response) | 87 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (moderate response) | 155 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (good response) | 64 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (no response) | 55 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (moderate response) | 181 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 14 (no response) | 77 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 6 (no response) | 74 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 30 (moderate response) | 155 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 12 (good response) | 88 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 | Week 22 (good response) | 96 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (good response) | 107 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (no response) | 29 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (no response) | 33 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (moderate response) | 126 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (good response) | 110 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (moderate response) | 109 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (no response) | 34 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (moderate response) | 132 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (good response) | 118 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (moderate response) | 64 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (good response) | 51 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (moderate response) | 62 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (no response) | 28 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (good response) | 46 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (no response) | 28 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (good response) | 53 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (moderate response) | 56 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (no response) | 20 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (no response) | 25 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (good response) | 49 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (good response) | 50 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 38 (moderate response) | 66 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (no response) | 16 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (moderate response) | 67 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (good response) | 49 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 54 (moderate response) | 62 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 | Week 46 (no response) | 17 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (good response) | 133 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (good response) | 122 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (moderate response) | 102 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (no response) | 25 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (good response) | 127 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (moderate response) | 92 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (no response) | 25 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (moderate response) | 84 participants |
| Period 1: PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (no response) | 22 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (moderate response) | 48 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (good response) | 58 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (good response) | 50 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (moderate response) | 45 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (good response) | 56 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (moderate response) | 56 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (no response) | 15 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (no response) | 11 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (no response) | 17 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (no response) | 15 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (good response) | 52 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (moderate response) | 53 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 70 (moderate response) | 54 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (no response) | 8 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (no response) | 13 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (good response) | 57 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 78 (good response) | 57 participants |
| Period 2: INX/PF-06438179 | Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 | Week 62 (moderate response) | 54 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Laboratory Abnormalities: Period 1 | 245 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Laboratory Abnormalities: Period 1 | 237 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Laboratory Abnormalities: Period 2 | 154 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Laboratory Abnormalities: Period 2 | 83 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Laboratory Abnormalities: Period 2 | 63 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Laboratory Abnormalities: Period 3 | 127 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Laboratory Abnormalities: Period 3 | 72 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Laboratory Abnormalities: Period 3 | 61 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 | ADA | 157 participants |
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 | NAb | 124 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 | ADA | 167 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 | NAb | 143 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | ADA | 146 participants |
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | NAb | 118 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | ADA | 86 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | NAb | 73 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | ADA | 83 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 | NAb | 65 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | ADA | 119 participants |
| Period 1: PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | NAb | 105 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | ADA | 66 participants |
| Period 1: Infliximab-EU Remicade (INX) | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | NAb | 58 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | NAb | 60 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 | ADA | 72 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 | TEAEs (Grade 3) | 34 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 | TEAEs (Grade 4) | 1 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 | TEAEs (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 1 | TEAEs (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 1 | TEAEs (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 1 | TEAEs (Grade 5) | 1 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (Grade 5) | 1 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (Grade 4) | 3 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (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 2 | TEAEs (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 2 | TEAEs (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 2 | TEAEs (Grade 5) | 0 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (Grade 3) | 6 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (Grade 5) | 0 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 | TEAEs (Grade 4) | 0 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (Grade 4) | 1 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (Grade 3) | 4 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (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 3 | TEAEs (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 3 | TEAEs (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 3 | TEAEs (Grade 5) | 0 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (Grade 3) | 7 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (Grade 5) | 0 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 | TEAEs (Grade 4) | 0 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 | TEAEs | 185 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 | SAEs | 16 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 | Treatment related TEAEs | 81 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 | Treatment related SAEs | 4 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 1 | Treatment related SAEs | 4 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 1 | TEAEs | 176 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 1 | Treatment related TEAEs | 75 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 1 | SAEs | 20 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | TEAEs | 103 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | SAEs | 13 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | Treatment related TEAEs | 32 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | Treatment related SAEs | 2 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 2 | Treatment related SAEs | 5 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 2 | TEAEs | 48 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 2 | Treatment related TEAEs | 20 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 2 | SAEs | 11 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | Treatment related SAEs | 0 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | SAEs | 4 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | Treatment related TEAEs | 16 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 | TEAEs | 54 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | TEAEs | 73 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | SAEs | 3 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | Treatment related TEAEs | 22 participants |
| Period 1: PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | Treatment related SAEs | 0 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 3 | Treatment related SAEs | 1 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 3 | TEAEs | 38 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 3 | Treatment related TEAEs | 10 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 3 | SAEs | 3 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | Treatment related SAEs | 3 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | SAEs | 6 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | Treatment related TEAEs | 8 participants |
| Period 2: INX/PF-06438179 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 | TEAEs | 37 participants |
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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 1 (2 hours) | 65310 nanograms/milliliters | Standard Deviation 24920 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 99 (0 hours) | 3547 nanograms/milliliters | Standard Deviation 9559.2 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 29 (336 hours) | 23640 nanograms/milliliters | Standard Deviation 12357 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 99 (2 hours) | 76030 nanograms/milliliters | Standard Deviation 39407 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 15 (0 hours) | 17350 nanograms/milliliters | Standard Deviation 8391.4 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 155 (0 hours) | 2051 nanograms/milliliters | Standard Deviation 3440.9 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 43 (0 hours) | 11440 nanograms/milliliters | Standard Deviation 10101 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 211 (0 hours) | 1781 nanograms/milliliters | Standard Deviation 2765.2 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 1 | Day 1 (0 hours) | 1635 nanograms/milliliters | Standard Deviation 11163 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 211 (0 hours) | 2112 nanograms/milliliters | Standard Deviation 11703 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 1 (0 hours) | 656.2 nanograms/milliliters | Standard Deviation 6583.8 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 1 (2 hours) | 62220 nanograms/milliliters | Standard Deviation 22129 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 15 (0 hours) | 16690 nanograms/milliliters | Standard Deviation 8002.7 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 29 (336 hours) | 21570 nanograms/milliliters | Standard Deviation 10986 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 43 (0 hours) | 10100 nanograms/milliliters | Standard Deviation 7721.7 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 99 (0 hours) | 2559 nanograms/milliliters | Standard Deviation 6360.3 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 99 (2 hours) | 73350 nanograms/milliliters | Standard Deviation 41410 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 1 | Day 155 (0 hours) | 1566 nanograms/milliliters | Standard Deviation 2321.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 211 (0 hours) | 1801 nanograms/milliliters | Standard Deviation 2773.4 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 267 (0 hours) | 1855 nanograms/milliliters | Standard Deviation 2871.7 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 379 (0 hours) | 2075 nanograms/milliliters | Standard Deviation 4054.6 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 547 (0 hours) | 499.6 nanograms/milliliters | Standard Deviation 1373 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 2 | Day 547 (0 hours) | 212.7 nanograms/milliliters | Standard Deviation 405.18 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 2 | Day 211 (0 hours) | 1083 nanograms/milliliters | Standard Deviation 1763.6 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 2 | Day 379 (0 hours) | 1823 nanograms/milliliters | Standard Deviation 6110.8 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 2 | Day 267 (0 hours) | 1208 nanograms/milliliters | Standard Deviation 1926.5 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 547 (0 hours) | 3305 nanograms/milliliters | Standard Deviation 8429.5 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 267 (0 hours) | 1620 nanograms/milliliters | Standard Deviation 2413.7 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 379 (0 hours) | 1734 nanograms/milliliters | Standard Deviation 2725.2 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 2 | Day 211 (0 hours) | 1819 nanograms/milliliters | Standard Deviation 2393.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 547 | 1707 nanograms/milliliters | Standard Deviation 2512.9 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 379 (0 hours) | 2078 nanograms/milliliters | Standard Deviation 4044 |
| Period 1: PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 435 (0 hours) | 1913 nanograms/milliliters | Standard Deviation 2838 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 3 | Day 547 | 1663 nanograms/milliliters | Standard Deviation 5305.7 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 3 | Day 435 (0 hours) | 1388 nanograms/milliliters | Standard Deviation 2387.4 |
| Period 1: Infliximab-EU Remicade (INX) | Serum Concentration Versus Time Summary: Period 3 | Day 379 (0 hours) | 1823 nanograms/milliliters | Standard Deviation 6110.8 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 547 | 1482 nanograms/milliliters | Standard Deviation 2441.6 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 435 (0 hours) | 1572 nanograms/milliliters | Standard Deviation 2543.4 |
| Period 2: INX/PF-06438179 | Serum Concentration Versus Time Summary: Period 3 | Day 379 (0 hours) | 1734 nanograms/milliliters | Standard Deviation 2725.2 |