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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02222493




Registration number
NCT02222493
Ethics application status
Date submitted
19/08/2014
Date registered
21/08/2014
Date last updated
30/05/2018

Titles & IDs
Public title
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Scientific title
A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
Secondary ID [1] 0 0
REFLECTIONS B537-02
Secondary ID [2] 0 0
B5371002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PF-06438179
Treatment: Other - Infliximab

Experimental: PF-06438179 -

Active comparator: Infliximab -


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

Treatment: Other: Infliximab
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Week 14
Secondary outcome [1] 0 0
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
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 2, 4, 6, 12, 22 and 30 (pre-dose)
Secondary outcome [2] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Week 38, 46 and 54 (pre-dose)
Secondary outcome [3] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Week 62, 70 and 78
Secondary outcome [4] 0 0
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
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
Secondary outcome [5] 0 0
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
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Week 38, 46 and 54 (pre-dose)
Secondary outcome [6] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Week 62, 70 and 78
Secondary outcome [7] 0 0
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
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Secondary outcome [8] 0 0
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Secondary outcome [9] 0 0
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Secondary outcome [10] 0 0
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Secondary outcome [11] 0 0
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Week 38, 46 and 54 (pre-dose)
Secondary outcome [12] 0 0
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Week 62, 70 and 78
Secondary outcome [13] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Secondary outcome [14] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Week 38, 46 and Week 54 (pre-dose)
Secondary outcome [15] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
Week 62, 70 and Week 78
Secondary outcome [16] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Assessment method [16] 0 0
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.
Timepoint [16] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [17] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
Baseline (Week 30 pre-dose) up to Week 54
Secondary outcome [18] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
Baseline (Week 54 pre-dose) up to Week 78
Secondary outcome [19] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
Assessment method [19] 0 0
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.
Timepoint [19] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [20] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
Assessment method [20] 0 0
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.
Timepoint [20] 0 0
Baseline (Week 30 pre-dose) up to Week 54
Secondary outcome [21] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
Assessment method [21] 0 0
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.
Timepoint [21] 0 0
Baseline (Week 54 pre-dose) up to Week 78
Secondary outcome [22] 0 0
Number of Participants With Laboratory Abnormalities: Period 1
Assessment method [22] 0 0
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\>\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.
Timepoint [22] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [23] 0 0
Number of Participants With Laboratory Abnormalities: Period 2
Assessment method [23] 0 0
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\>\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.
Timepoint [23] 0 0
Baseline (Week 30 pre-dose) up to Week 54
Secondary outcome [24] 0 0
Number of Participants With Laboratory Abnormalities: Period 3
Assessment method [24] 0 0
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\>\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.
Timepoint [24] 0 0
Baseline (Week 54 pre-dose) up to Week 78
Secondary outcome [25] 0 0
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Assessment method [25] 0 0
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.
Timepoint [25] 0 0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30
Secondary outcome [26] 0 0
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
Assessment method [26] 0 0
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.
Timepoint [26] 0 0
Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
Secondary outcome [27] 0 0
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
Assessment method [27] 0 0
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.
Timepoint [27] 0 0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Secondary outcome [28] 0 0
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
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Secondary outcome [29] 0 0
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
Assessment method [29] 0 0
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.
Timepoint [29] 0 0
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Secondary outcome [30] 0 0
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
Assessment method [30] 0 0
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.
Timepoint [30] 0 0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Secondary outcome [31] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Assessment method [31] 0 0
Timepoint [31] 0 0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Secondary outcome [32] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2
Assessment method [32] 0 0
Timepoint [32] 0 0
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Secondary outcome [33] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3
Assessment method [33] 0 0
Timepoint [33] 0 0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Secondary outcome [34] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
Assessment method [34] 0 0
ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Timepoint [34] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [35] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
Assessment method [35] 0 0
ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Timepoint [35] 0 0
Baseline (Week 30 pre-dose) up to Week 54
Secondary outcome [36] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
Assessment method [36] 0 0
ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.
Timepoint [36] 0 0
Baseline (Week 54 pre-dose) up to Week 78
Secondary outcome [37] 0 0
Serum Concentration Versus Time Summary: Period 1
Assessment method [37] 0 0
Timepoint [37] 0 0
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
Secondary outcome [38] 0 0
Serum Concentration Versus Time Summary: Period 2
Assessment method [38] 0 0
Timepoint [38] 0 0
Pre dose on Day 211, 267, 379 and 547
Secondary outcome [39] 0 0
Serum Concentration Versus Time Summary: Period 3
Assessment method [39] 0 0
Timepoint [39] 0 0
Pre dose on Day 379, 435 and 547

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Gold Coast Private Hospital Pty Ltd - Southport
Recruitment hospital [2] 0 0
HPS Pharmacies - Southport
Recruitment hospital [3] 0 0
Paradise Arthritis and Rheumatology Pty Ltd - Southport
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
CliniPath Pathology - Osborne Park
Recruitment hospital [6] 0 0
R.K. Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
6017 - Osborne Park
Recruitment postcode(s) [4] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
South Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Bosnia and Herzegovina
State/province [23] 0 0
Kanton Sarajevo
Country [24] 0 0
Bosnia and Herzegovina
State/province [24] 0 0
Tuzlanski Kanton
Country [25] 0 0
Bosnia and Herzegovina
State/province [25] 0 0
Banja Luka
Country [26] 0 0
Brazil
State/province [26] 0 0
Paraná
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Plovdiv
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
Country [32] 0 0
Czechia
State/province [32] 0 0
Pardubice
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 3
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha
Country [35] 0 0
Czechia
State/province [35] 0 0
Uherske Hradiste
Country [36] 0 0
Georgia
State/province [36] 0 0
Tbilisi
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Germany
State/province [39] 0 0
Olsberg
Country [40] 0 0
Germany
State/province [40] 0 0
Puettlingen
Country [41] 0 0
Germany
State/province [41] 0 0
Ratingen
Country [42] 0 0
Guatemala
State/province [42] 0 0
Guatemala
Country [43] 0 0
Hungary
State/province [43] 0 0
Balatonfüred
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Israel
State/province [45] 0 0
Haifa
Country [46] 0 0
Israel
State/province [46] 0 0
Jerusalem
Country [47] 0 0
Israel
State/province [47] 0 0
Kfar Saba
Country [48] 0 0
Japan
State/province [48] 0 0
Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Fukuoka
Country [50] 0 0
Japan
State/province [50] 0 0
Gunma
Country [51] 0 0
Japan
State/province [51] 0 0
Hiroshima
Country [52] 0 0
Japan
State/province [52] 0 0
Hokkaido
Country [53] 0 0
Japan
State/province [53] 0 0
Hyogo
Country [54] 0 0
Japan
State/province [54] 0 0
Kanagawa
Country [55] 0 0
Japan
State/province [55] 0 0
Nagasaki
Country [56] 0 0
Japan
State/province [56] 0 0
Okayama
Country [57] 0 0
Japan
State/province [57] 0 0
Okinawa
Country [58] 0 0
Japan
State/province [58] 0 0
Saitama
Country [59] 0 0
Japan
State/province [59] 0 0
Shizuoka
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
Country [61] 0 0
Japan
State/province [61] 0 0
Chiba
Country [62] 0 0
Japan
State/province [62] 0 0
Kumamoto
Country [63] 0 0
Jordan
State/province [63] 0 0
Amman
Country [64] 0 0
Jordan
State/province [64] 0 0
Irbid
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Daejeon
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gwangju
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Lithuania
State/province [68] 0 0
Kaunas
Country [69] 0 0
Mexico
State/province [69] 0 0
SAN LUIS DE Potosi
Country [70] 0 0
Mexico
State/province [70] 0 0
Yucatan
Country [71] 0 0
Morocco
State/province [71] 0 0
Salé
Country [72] 0 0
Peru
State/province [72] 0 0
Lima
Country [73] 0 0
Peru
State/province [73] 0 0
Arequipa
Country [74] 0 0
Philippines
State/province [74] 0 0
Batangas
Country [75] 0 0
Philippines
State/province [75] 0 0
Davao DEL SUR
Country [76] 0 0
Philippines
State/province [76] 0 0
Metro Manila
Country [77] 0 0
Philippines
State/province [77] 0 0
Manila
Country [78] 0 0
Philippines
State/province [78] 0 0
Quezon
Country [79] 0 0
Poland
State/province [79] 0 0
Bydgoszcz
Country [80] 0 0
Poland
State/province [80] 0 0
Krakow
Country [81] 0 0
Poland
State/province [81] 0 0
Nadarzyn
Country [82] 0 0
Poland
State/province [82] 0 0
Nowa Sol
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Romania
State/province [84] 0 0
Galati
Country [85] 0 0
Romania
State/province [85] 0 0
Iasi
Country [86] 0 0
Romania
State/province [86] 0 0
Targu Mures
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Republic OF Karelia
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Kemerovo
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Krasnoyarsk
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Kursk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Ryazan
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Saint-Petersburg
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Saratov
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Vladimir
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Yaroslavl
Country [97] 0 0
Serbia
State/province [97] 0 0
Belgrade
Country [98] 0 0
Serbia
State/province [98] 0 0
Niska Banja
Country [99] 0 0
South Africa
State/province [99] 0 0
Gauteng
Country [100] 0 0
South Africa
State/province [100] 0 0
Western CAPE
Country [101] 0 0
Tunisia
State/province [101] 0 0
Manouba
Country [102] 0 0
Tunisia
State/province [102] 0 0
Tunis
Country [103] 0 0
Ukraine
State/province [103] 0 0
Dnipropetrovsk
Country [104] 0 0
Ukraine
State/province [104] 0 0
Ivano-Frankivsk
Country [105] 0 0
Ukraine
State/province [105] 0 0
Kharkiv
Country [106] 0 0
Ukraine
State/province [106] 0 0
Khmelnytskyi
Country [107] 0 0
Ukraine
State/province [107] 0 0
Kyiv
Country [108] 0 0
Ukraine
State/province [108] 0 0
Lviv
Country [109] 0 0
Ukraine
State/province [109] 0 0
M. Kryvyi Rih
Country [110] 0 0
Ukraine
State/province [110] 0 0
M. Sumy
Country [111] 0 0
Ukraine
State/province [111] 0 0
M. Vinnytsia
Country [112] 0 0
Ukraine
State/province [112] 0 0
Odesa
Country [113] 0 0
Ukraine
State/province [113] 0 0
Zaporizhzhia
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Lancashire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Maidstone

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02222493