A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
2 other identifiers
interventional
455
10 countries
72
Brief Summary
The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Jan 2020
Shorter than P25 for phase_3 rheumatoid-arthritis
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2020
CompletedFirst Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedResults Posted
Study results publicly available
August 22, 2022
CompletedFebruary 22, 2024
January 1, 2024
1.4 years
January 14, 2020
June 17, 2022
January 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Observed Serum Concentration (Cmax) of Adalimumab
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Secondary Outcomes (29)
Time to Reach Cmax (Tmax) of Adalimumab
Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Average Serum Concentration (Cav) of Adalimumab
Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Apparent Clearance (CL/F) of Serum Adalimumab
Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab
Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
Day 1 up to maximum of 10 Weeks
- +24 more secondary outcomes
Study Arms (2)
Treatment Arm 1
EXPERIMENTALSubcutaneous (SC) injection given every other week
Treatment Arm 2
ACTIVE COMPARATORSC injection given every other week
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
- Moderately to severely active RA based on local standard of care.
You may not qualify if:
- Evidence of untreated or inadequately treated latent or active TB.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (72)
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801, United States
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Health Center Gradiska
Gradiška, 78400, Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
General Hospital Prim. Dr.Abdulah Nakas
Sarajevo, 71000, Bosnia and Herzegovina
UMHAT "Dr Georgi Stranski" EAD
Pleven, 5800, Bulgaria
DCC Sveti Georgi
Plovdiv, 4002, Bulgaria
Unimed Medical Centre
Plovdiv, 4023, Bulgaria
IMEDICA s.r.o.
Brno, 602 00, Czechia
Lekarna Na Lidicke
Brno, 602 00, Czechia
Lekarna Biovita
Brno, 60200, Czechia
X-Medica, s.r.o.
Brno, 613 00, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno, 615 00, Czechia
L.K.N. Arthrocentrum, s.r.o.
Hlučín, 748 01, Czechia
Plicni ambulance
Hlučín, 748 01, Czechia
Chirurgie Sibenik
Olomouc, 779 00, Czechia
CTCenter MaVe s.r.o
Olomouc, 779 00, Czechia
Lekarna u Pottingea
Olomouc, 779 00, Czechia
Lekarna Vesalion
Ostrava, 702 00, Czechia
CCR Czech a.s.
Pardubice, 530 02, Czechia
Lekarna BENU
Pardubice, 530 02, Czechia
Lekarna Pod Platany
Prague, 101 00, Czechia
Revmatologicky ustav
Prague, 12850, Czechia
CCR Prague s.r.o.
Prague, 130 00, Czechia
Diagnostické centrum Olšanská s.r.o.
Prague, 13000, Czechia
Fakultni Nemocnice v Motole
Prague, 150 06, Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, 68601, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, 68601, Czechia
Radiodiagnosticka ordinace a pracoviste
Uherské Hradiště, 68601, Czechia
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
Kaunas, LT-50161, Lithuania
Klaipeda University Hospital
Klaipėda, LT-92288, Lithuania
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, 15-099, Poland
NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik
Bialystok, 15-351, Poland
Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.
Krakow, 30-002, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-582, Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, 05-830, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, 02-118, Poland
Limited Liability Company "Clinic on Maroseyka"
Moscow, 101000, Russia
Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"
Novosibirsk, 630099, Russia
FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg, 460000, Russia
GBUZ "Orenburg Regional Clinical Hospital"
Orenburg, 460018, Russia
SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
Petrozavodsk, 185910, Russia
FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
Ryazan, 390026, Russia
SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"
Ryazan, 390026, Russia
SBI of Ryazan Region "Regional Clinical Hospital"
Ryazan, 390039, Russia
Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
Smolensk, 214019, Russia
LLC "BioMed"
Vladimir, 600005, Russia
LLC "Center for Medical Advice and Research-PRACTICE"
Yaroslavl, 150003, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, 18205, Serbia
Special Hospital for Rheumatic Diseases Novi Sad
Novi Sad, 21000, Serbia
Emmed Research
Pretoria, Gauteng, 0002, South Africa
Jakaranda Hospital
Pretoria, Gauteng, 0002, South Africa
Arthritis Clinical Research Trials
Cape Town, Western Cape, 7405, South Africa
Panorama Medical Centre
Cape Town, Western Cape, 7500, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600, South Africa
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia
Kharkiv, 61058, Ukraine
Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "
Kyiv, 02081, Ukraine
Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska
Kyiv, 03680, Ukraine
Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia
M. Ivano-Frankivsk, 76018, Ukraine
Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"
Odesa, 65025, Ukraine
Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu
Odesa, 65026, Ukraine
Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
Vinnytsia, 21028, Ukraine
Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady
Zhytomyr, 10002, Ukraine
Related Publications (1)
Fleischmann RM, Saikali W, Lakhanpal S, Alvarez DF, Cox DS, Ianos CA, Zhang W, Cronenberger C, Wang K. Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. Lancet Rheumatol. 2023 Sep;5(9):e532-e541. doi: 10.1016/S2665-9913(23)00161-3. Epub 2023 Aug 21.
PMID: 38251497DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In participant flow, there were discontinuations due to AEs, which were captured within different reasons for discontinuations (e.g. other, physician decision etc.) as the study case report form (CRF) page did not include AE as an option for sites to record if the discontinuation was truly due to AE.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 18, 2020
Study Start
January 13, 2020
Primary Completion
June 22, 2021
Study Completion
June 22, 2021
Last Updated
February 22, 2024
Results First Posted
August 22, 2022
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.