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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Timepoint [22] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [23] 0 0
Number of Participants With Laboratory Abnormalities: Period 2
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
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United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
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United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
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Iowa
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United States of America
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Kentucky
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Louisiana
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Maryland
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Michigan
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New Jersey
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United States of America
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North Dakota
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Bosnia and Herzegovina
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Kanton Sarajevo
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Bosnia and Herzegovina
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Tuzlanski Kanton
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Bosnia and Herzegovina
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Banja Luka
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Brazil
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Paraná
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Brazil
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São Paulo
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Bulgaria
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Plovdiv
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Sofia
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Pardubice
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Czechia
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Praha 3
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Czechia
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Praha
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Czechia
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Uherske Hradiste
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Georgia
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Tbilisi
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Germany
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Berlin
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Germany
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München
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Germany
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Olsberg
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Germany
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Puettlingen
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Germany
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Ratingen
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Guatemala
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Guatemala
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Hungary
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Balatonfüred
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Hungary
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Budapest
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Gunma
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Hiroshima
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Hokkaido
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Hyogo
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Kanagawa
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Japan
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Nagasaki
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Japan
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Okayama
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Japan
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Okinawa
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Japan
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Saitama
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Japan
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Shizuoka
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Tokyo
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Japan
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Chiba
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Kumamoto
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Jordan
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Amman
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Jordan
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Irbid
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Mexico
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SAN LUIS DE Potosi
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Mexico
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Yucatan
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Morocco
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Salé
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Peru
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Lima
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Peru
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Arequipa
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Philippines
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Batangas
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Philippines
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Davao DEL SUR
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Philippines
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Metro Manila
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Philippines
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Manila
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Philippines
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Quezon
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Nadarzyn
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Poland
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Nowa Sol
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Poland
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Warszawa
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Romania
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Galati
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Romania
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Iasi
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Romania
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Targu Mures
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Russian Federation
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Republic OF Karelia
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Niska Banja
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South Africa
State/province [99] 0 0
Gauteng
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South Africa
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Western CAPE
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Tunisia
State/province [101] 0 0
Manouba
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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
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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
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02222493
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.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02222493