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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02480153




Registration number
NCT02480153
Ethics application status
Date submitted
19/06/2015
Date registered
24/06/2015
Date last updated
23/01/2019

Titles & IDs
Public title
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB 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
B5381002, REFLECTIONS B538-02
Secondary ID [2] 0 0
B5381002
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-06410293
Treatment: Other - Adalimumab

Experimental: PF-06410293 -

Active comparator: Adalimumab -


Treatment: Other: PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Treatment: Other: Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Timepoint [1] 0 0
Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)
Secondary outcome [2] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Timepoint [2] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [3] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Timepoint [3] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [4] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Timepoint [4] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [5] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Timepoint [5] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [6] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Timepoint [6] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [7] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Timepoint [7] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [8] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Timepoint [8] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [9] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Timepoint [9] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [10] 0 0
Change From Baseline in Tender Joint Count: Period 1
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [11] 0 0
Change From Baseline in Tender Joint Count: Period 2
Timepoint [11] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [12] 0 0
Change From Baseline in Tender Joint Count: Period 3
Timepoint [12] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [13] 0 0
Change From Baseline in Swollen Joint Count: Period 1
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [14] 0 0
Change From Baseline in Swollen Joint Count: Period 2
Timepoint [14] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [15] 0 0
Change From Baseline in Swollen Joint Count: Period 3
Timepoint [15] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [16] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [17] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Timepoint [17] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [18] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Timepoint [18] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [19] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [20] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Timepoint [20] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [21] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Timepoint [21] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [22] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [23] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Timepoint [23] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [24] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Timepoint [24] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [25] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [26] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Timepoint [26] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [27] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Timepoint [27] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [28] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Timepoint [28] 0 0
Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [29] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Timepoint [29] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [30] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Timepoint [30] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [31] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Timepoint [31] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [32] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Timepoint [32] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [33] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Timepoint [33] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [34] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Timepoint [34] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [35] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Timepoint [35] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [36] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Timepoint [36] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [37] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Timepoint [37] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [38] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Timepoint [38] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [39] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Timepoint [39] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [40] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response:Period 1
Timepoint [40] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [41] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Timepoint [41] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [42] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Timepoint [42] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [43] 0 0
Serum Concentration Versus Time Summary: Period 1
Timepoint [43] 0 0
Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit
Secondary outcome [44] 0 0
Serum Concentration Versus Time Summary: Period 2
Timepoint [44] 0 0
Pre-dose on Days 183, 211, 253 and 365
Secondary outcome [45] 0 0
Serum Concentration Versus Time Summary: Period 3
Timepoint [45] 0 0
Pre-dose on Days 365, 393, 463, 547 and 575
Secondary outcome [46] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1
Timepoint [46] 0 0
Baseline up to Week 26 (pre-dose)
Secondary outcome [47] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2
Timepoint [47] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [48] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3
Timepoint [48] 0 0
Week 52 dosing up to follow-up visit (Week 92)
Secondary outcome [49] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Timepoint [49] 0 0
Baseline (Day 1) up to Week 26 (pre-dose)
Secondary outcome [50] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Timepoint [50] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [51] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Timepoint [51] 0 0
Week 52 dosing up to follow-up visit (Week 92)
Secondary outcome [52] 0 0
Number of Participants With Laboratory Abnormalities: Period 1
Timepoint [52] 0 0
Baseline (Day 1) up to Week 26 (pre-dose)
Secondary outcome [53] 0 0
Number of Participants With Laboratory Abnormalities: Period 2
Timepoint [53] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [54] 0 0
Number of Participants With Laboratory Abnormalities: Period 3
Timepoint [54] 0 0
Week 52 dosing up to follow-up visit (Week 92)

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 8 mg/L.
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
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 of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
* History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
* May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
* Any second DMARD must be washed out prior to the first study dose.

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
25/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2017
Sample size
Target
Accrual to date
Final
597
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Paradise Arthritis & Rheumatology Pty Ltd - Southport
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [3] 0 0
RK 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
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
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
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
Brazil
State/province [24] 0 0
Paraná
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Plovdiv
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Sofia
Country [27] 0 0
Colombia
State/province [27] 0 0
Bogota
Country [28] 0 0
Czechia
State/province [28] 0 0
Bruntal
Country [29] 0 0
Czechia
State/province [29] 0 0
Hlucin
Country [30] 0 0
Czechia
State/province [30] 0 0
Ostrava
Country [31] 0 0
Czechia
State/province [31] 0 0
Pardubice
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 2
Country [33] 0 0
Czechia
State/province [33] 0 0
Uherske Hradiste
Country [34] 0 0
Estonia
State/province [34] 0 0
Tallinn
Country [35] 0 0
Georgia
State/province [35] 0 0
Ajaria
Country [36] 0 0
Georgia
State/province [36] 0 0
Kakheti
Country [37] 0 0
Georgia
State/province [37] 0 0
Tbilisi
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Hildesheim
Country [40] 0 0
Germany
State/province [40] 0 0
München
Country [41] 0 0
Germany
State/province [41] 0 0
Planegg
Country [42] 0 0
Germany
State/province [42] 0 0
Püttlingen
Country [43] 0 0
Germany
State/province [43] 0 0
Ratingen
Country [44] 0 0
Hungary
State/province [44] 0 0
Hajdú-bihar
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Veszprem
Country [47] 0 0
Japan
State/province [47] 0 0
Aichi
Country [48] 0 0
Japan
State/province [48] 0 0
Gunma
Country [49] 0 0
Japan
State/province [49] 0 0
Hokkaido
Country [50] 0 0
Japan
State/province [50] 0 0
Hyogo
Country [51] 0 0
Japan
State/province [51] 0 0
Nagasaki
Country [52] 0 0
Japan
State/province [52] 0 0
Saitama
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Gwangju
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Lithuania
State/province [56] 0 0
Kaunas
Country [57] 0 0
Lithuania
State/province [57] 0 0
Klaipeda
Country [58] 0 0
Lithuania
State/province [58] 0 0
Vilnius
Country [59] 0 0
Mexico
State/province [59] 0 0
BAJA California
Country [60] 0 0
Mexico
State/province [60] 0 0
Ciudad de Mexico
Country [61] 0 0
New Zealand
State/province [61] 0 0
South Canterbury
Country [62] 0 0
New Zealand
State/province [62] 0 0
Hamilton
Country [63] 0 0
New Zealand
State/province [63] 0 0
Wellington
Country [64] 0 0
Peru
State/province [64] 0 0
Arequipa, Arequipa
Country [65] 0 0
Peru
State/province [65] 0 0
Arequipa
Country [66] 0 0
Peru
State/province [66] 0 0
Lima, Lima
Country [67] 0 0
Peru
State/province [67] 0 0
Lima
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Elblag
Country [70] 0 0
Poland
State/province [70] 0 0
Gdynia
Country [71] 0 0
Poland
State/province [71] 0 0
Katowice
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Nadarzyn
Country [74] 0 0
Poland
State/province [74] 0 0
Poznan
Country [75] 0 0
Poland
State/province [75] 0 0
Torun
Country [76] 0 0
Poland
State/province [76] 0 0
Warszawa
Country [77] 0 0
Poland
State/province [77] 0 0
Wroclaw
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Republic OF Karelia
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Izhevsk
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Kemerovo
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Kursk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Moscow
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Orenburg
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Ryazan
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Saint-Petersburg
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Saratov
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Vladimir
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Yaroslavl
Country [89] 0 0
Serbia
State/province [89] 0 0
Belgrade
Country [90] 0 0
Serbia
State/province [90] 0 0
Niska Banja
Country [91] 0 0
Serbia
State/province [91] 0 0
Novi Sad
Country [92] 0 0
South Africa
State/province [92] 0 0
Gauteng
Country [93] 0 0
South Africa
State/province [93] 0 0
Kwa-zulu Natal
Country [94] 0 0
South Africa
State/province [94] 0 0
Western CAPE
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Vizcaya
Country [97] 0 0
Spain
State/province [97] 0 0
A Coruña
Country [98] 0 0
Spain
State/province [98] 0 0
Sevilla
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taichung
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taipei
Country [101] 0 0
Ukraine
State/province [101] 0 0
Kyiv
Country [102] 0 0
Ukraine
State/province [102] 0 0
Lviv
Country [103] 0 0
Ukraine
State/province [103] 0 0
M. Kharkiv
Country [104] 0 0
Ukraine
State/province [104] 0 0
M. Kyiv,
Country [105] 0 0
Ukraine
State/province [105] 0 0
Odesa
Country [106] 0 0
Ukraine
State/province [106] 0 0
Sumy
Country [107] 0 0
Ukraine
State/province [107] 0 0
Vinnytsia
Country [108] 0 0
Ukraine
State/province [108] 0 0
Zaporizhzhia
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Hampshire
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Merseyside
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Somerset
Country [112] 0 0
United Kingdom
State/province [112] 0 0
WEST Yorkshire

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, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.
Trial website
https://clinicaltrials.gov/study/NCT02480153
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.
Fleischmann RM, Bock AE, Zhang W, Godfrey CM, Vranic I, Cronenberger C, Dokoupilova E. Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2022 Jun;9(3):839-850. doi: 10.1007/s40744-022-00439-8. Epub 2022 Mar 18.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira(R)) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial. Arthritis Res Ther. 2021 Sep 25;23(1):248. doi: 10.1186/s13075-021-02626-4.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293. RMD Open. 2021 Apr;7(2):e001578. doi: 10.1136/rmdopen-2021-001578.
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira(R)) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02480153