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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).
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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
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Secondary ID [1]
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REFLECTIONS B537-02
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Secondary ID [2]
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B5371002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
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Assessment method [1]
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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).
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Timepoint [1]
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Week 14
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Week 2, 4, 6, 12, 22 and 30 (pre-dose)
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Secondary outcome [2]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
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Assessment method [2]
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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.
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Timepoint [2]
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Week 38, 46 and 54 (pre-dose)
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Secondary outcome [3]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
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Assessment method [3]
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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.
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Timepoint [3]
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Week 62, 70 and 78
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Week 38, 46 and 54 (pre-dose)
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Secondary outcome [6]
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Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
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Assessment method [6]
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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.
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Timepoint [6]
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Week 62, 70 and 78
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
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Secondary outcome [8]
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Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline (Week 30 pre-dose), Week 38, 46 and 54
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Secondary outcome [9]
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Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (Week 54 pre-dose), Week 62, 70 and 78
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Secondary outcome [10]
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Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
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Assessment method [10]
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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.
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Timepoint [10]
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Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
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Secondary outcome [11]
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Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
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Assessment method [11]
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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.
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Timepoint [11]
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Week 38, 46 and 54 (pre-dose)
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Secondary outcome [12]
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Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
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Assessment method [12]
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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.
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Timepoint [12]
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Week 62, 70 and 78
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Secondary outcome [13]
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Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
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Assessment method [13]
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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.
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Timepoint [13]
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Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
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Secondary outcome [14]
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Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
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Assessment method [14]
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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.
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Timepoint [14]
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Week 38, 46 and Week 54 (pre-dose)
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Secondary outcome [15]
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Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
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Assessment method [15]
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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.
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Timepoint [15]
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Week 62, 70 and Week 78
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Secondary outcome [16]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline (Day 1) up to Week 30
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Secondary outcome [17]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline (Week 30 pre-dose) up to Week 54
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Secondary outcome [18]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline (Week 54 pre-dose) up to Week 78
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Secondary outcome [19]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline (Day 1) up to Week 30
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Secondary outcome [20]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline (Week 30 pre-dose) up to Week 54
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Secondary outcome [21]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline (Week 54 pre-dose) up to Week 78
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Secondary outcome [22]
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Number of Participants With Laboratory Abnormalities: Period 1
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline (Day 1) up to Week 30
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Secondary outcome [23]
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Number of Participants With Laboratory Abnormalities: Period 2
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Assessment method [23]
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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.
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Timepoint [23]
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0
Baseline (Week 30 pre-dose) up to Week 54
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Secondary outcome [24]
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Number of Participants With Laboratory Abnormalities: Period 3
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Assessment method [24]
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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.
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Timepoint [24]
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0
Baseline (Week 54 pre-dose) up to Week 78
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Secondary outcome [25]
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Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30
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Secondary outcome [26]
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Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
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Assessment method [26]
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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.
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Timepoint [26]
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0
Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
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Secondary outcome [27]
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Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
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Assessment method [27]
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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.
Query!
Timepoint [27]
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0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
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Secondary outcome [28]
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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
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Assessment method [28]
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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.
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Timepoint [28]
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0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
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Secondary outcome [29]
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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
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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.
Query!
Timepoint [29]
0
0
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Query!
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
Query!
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.
Query!
Timepoint [30]
0
0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Query!
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
Query!
Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Query!
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
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Query!
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
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Query!
Secondary outcome [34]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
Query!
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.
Query!
Timepoint [34]
0
0
Baseline (Day 1) up to Week 30
Query!
Secondary outcome [35]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
Query!
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.
Query!
Timepoint [35]
0
0
Baseline (Week 30 pre-dose) up to Week 54
Query!
Secondary outcome [36]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
Query!
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.
Query!
Timepoint [36]
0
0
Baseline (Week 54 pre-dose) up to Week 78
Query!
Secondary outcome [37]
0
0
Serum Concentration Versus Time Summary: Period 1
Query!
Assessment method [37]
0
0
Query!
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
Query!
Secondary outcome [38]
0
0
Serum Concentration Versus Time Summary: Period 2
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Pre dose on Day 211, 267, 379 and 547
Query!
Secondary outcome [39]
0
0
Serum Concentration Versus Time Summary: Period 3
Query!
Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Pre dose on Day 379, 435 and 547
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/08/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
650
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Gold Coast Private Hospital Pty Ltd - Southport
Query!
Recruitment hospital [2]
0
0
HPS Pharmacies - Southport
Query!
Recruitment hospital [3]
0
0
Paradise Arthritis and Rheumatology Pty Ltd - Southport
Query!
Recruitment hospital [4]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [5]
0
0
CliniPath Pathology - Osborne Park
Query!
Recruitment hospital [6]
0
0
R.K. Will Pty Ltd - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [2]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [3]
0
0
6017 - Osborne Park
Query!
Recruitment postcode(s) [4]
0
0
6100 - Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Delaware
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Dakota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Dakota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Bosnia and Herzegovina
Query!
State/province [23]
0
0
Kanton Sarajevo
Query!
Country [24]
0
0
Bosnia and Herzegovina
Query!
State/province [24]
0
0
Tuzlanski Kanton
Query!
Country [25]
0
0
Bosnia and Herzegovina
Query!
State/province [25]
0
0
Banja Luka
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Paraná
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
São Paulo
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Plovdiv
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Sofia
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Brno
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Pardubice
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Praha 3
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Praha
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Uherske Hradiste
Query!
Country [36]
0
0
Georgia
Query!
State/province [36]
0
0
Tbilisi
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Berlin
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
München
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Olsberg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Puettlingen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Ratingen
Query!
Country [42]
0
0
Guatemala
Query!
State/province [42]
0
0
Guatemala
Query!
Country [43]
0
0
Hungary
Query!
State/province [43]
0
0
Balatonfüred
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Budapest
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Haifa
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Jerusalem
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Kfar Saba
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Aichi
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Fukuoka
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Gunma
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Hiroshima
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Hokkaido
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Hyogo
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Kanagawa
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Nagasaki
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Okayama
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Okinawa
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Saitama
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Shizuoka
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Tokyo
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Chiba
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Kumamoto
Query!
Country [63]
0
0
Jordan
Query!
State/province [63]
0
0
Amman
Query!
Country [64]
0
0
Jordan
Query!
State/province [64]
0
0
Irbid
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Daejeon
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Gwangju
Query!
Country [67]
0
0
Korea, Republic of
Query!
State/province [67]
0
0
Seoul
Query!
Country [68]
0
0
Lithuania
Query!
State/province [68]
0
0
Kaunas
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
SAN LUIS DE Potosi
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Yucatan
Query!
Country [71]
0
0
Morocco
Query!
State/province [71]
0
0
Salé
Query!
Country [72]
0
0
Peru
Query!
State/province [72]
0
0
Lima
Query!
Country [73]
0
0
Peru
Query!
State/province [73]
0
0
Arequipa
Query!
Country [74]
0
0
Philippines
Query!
State/province [74]
0
0
Batangas
Query!
Country [75]
0
0
Philippines
Query!
State/province [75]
0
0
Davao DEL SUR
Query!
Country [76]
0
0
Philippines
Query!
State/province [76]
0
0
Metro Manila
Query!
Country [77]
0
0
Philippines
Query!
State/province [77]
0
0
Manila
Query!
Country [78]
0
0
Philippines
Query!
State/province [78]
0
0
Quezon
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Bydgoszcz
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Krakow
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Nadarzyn
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Nowa Sol
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Warszawa
Query!
Country [84]
0
0
Romania
Query!
State/province [84]
0
0
Galati
Query!
Country [85]
0
0
Romania
Query!
State/province [85]
0
0
Iasi
Query!
Country [86]
0
0
Romania
Query!
State/province [86]
0
0
Targu Mures
Query!
Country [87]
0
0
Russian Federation
Query!
State/province [87]
0
0
Republic OF Karelia
Query!
Country [88]
0
0
Russian Federation
Query!
State/province [88]
0
0
Kemerovo
Query!
Country [89]
0
0
Russian Federation
Query!
State/province [89]
0
0
Krasnoyarsk
Query!
Country [90]
0
0
Russian Federation
Query!
State/province [90]
0
0
Kursk
Query!
Country [91]
0
0
Russian Federation
Query!
State/province [91]
0
0
Moscow
Query!
Country [92]
0
0
Russian Federation
Query!
State/province [92]
0
0
Ryazan
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Saint-Petersburg
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Saratov
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Vladimir
Query!
Country [96]
0
0
Russian Federation
Query!
State/province [96]
0
0
Yaroslavl
Query!
Country [97]
0
0
Serbia
Query!
State/province [97]
0
0
Belgrade
Query!
Country [98]
0
0
Serbia
Query!
State/province [98]
0
0
Niska Banja
Query!
Country [99]
0
0
South Africa
Query!
State/province [99]
0
0
Gauteng
Query!
Country [100]
0
0
South Africa
Query!
State/province [100]
0
0
Western CAPE
Query!
Country [101]
0
0
Tunisia
Query!
State/province [101]
0
0
Manouba
Query!
Country [102]
0
0
Tunisia
Query!
State/province [102]
0
0
Tunis
Query!
Country [103]
0
0
Ukraine
Query!
State/province [103]
0
0
Dnipropetrovsk
Query!
Country [104]
0
0
Ukraine
Query!
State/province [104]
0
0
Ivano-Frankivsk
Query!
Country [105]
0
0
Ukraine
Query!
State/province [105]
0
0
Kharkiv
Query!
Country [106]
0
0
Ukraine
Query!
State/province [106]
0
0
Khmelnytskyi
Query!
Country [107]
0
0
Ukraine
Query!
State/province [107]
0
0
Kyiv
Query!
Country [108]
0
0
Ukraine
Query!
State/province [108]
0
0
Lviv
Query!
Country [109]
0
0
Ukraine
Query!
State/province [109]
0
0
M. Kryvyi Rih
Query!
Country [110]
0
0
Ukraine
Query!
State/province [110]
0
0
M. Sumy
Query!
Country [111]
0
0
Ukraine
Query!
State/province [111]
0
0
M. Vinnytsia
Query!
Country [112]
0
0
Ukraine
Query!
State/province [112]
0
0
Odesa
Query!
Country [113]
0
0
Ukraine
Query!
State/province [113]
0
0
Zaporizhzhia
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Lancashire
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Maidstone
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02222493
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Trial related presentations / publications
Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423. Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z. Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8. Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019. Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.
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Results are available at
https://clinicaltrials.gov/study/NCT02222493
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