A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Last updated: January 26, 2024
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Rheumatoid Arthritis

Treatment

PF-06410293

adalimumab

Clinical Study ID

NCT04230213
B5381012
B5381012
2019-000284-24
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

-Evidence of untreated or inadequately treated latent or active TB.

Study Design

Total Participants: 455
Treatment Group(s): 2
Primary Treatment: PF-06410293
Phase: 3
Study Start date:
January 13, 2020
Estimated Completion Date:
June 22, 2021

Connect with a study center

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Health Center Gradiska

    Gradiska, 78400
    Bosnia and Herzegovina

    Site Not Available

  • Clinical Center University of Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • General Hospital Prim. Dr.Abdulah Nakas

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • UMHAT "Dr Georgi Stranski" EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • DCC Sveti Georgi

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Unimed Medical Centre

    Plovdiv, 4023
    Bulgaria

    Site Not Available

  • Multiprofile hospital for active treatment - "Lyulin" EAD

    Sofia, 1336
    Bulgaria

    Site Not Available

  • IMEDICA s.r.o.

    Brno, 602 00
    Czechia

    Site Not Available

  • Lekarna Biovita

    Brno, 60200
    Czechia

    Site Not Available

  • Lekarna Na Lidicke

    Brno, 602 00
    Czechia

    Site Not Available

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno, 615 00
    Czechia

    Site Not Available

  • X-Medica, s.r.o.

    Brno, 613 00
    Czechia

    Site Not Available

  • L.K.N. Arthrocentrum, s.r.o.

    Hlucin, 748 01
    Czechia

    Site Not Available

  • Plicni ambulance

    Hlucin, 748 01
    Czechia

    Site Not Available

  • CTCenter MaVe s.r.o

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Chirurgie Sibenik

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Lekarna u Pottingea

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Lekarna Vesalion

    Ostrava, 702 00
    Czechia

    Site Not Available

  • CCR Czech a.s.

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Lekarna BENU

    Pardubice, 530 02
    Czechia

    Site Not Available

  • CCR Prague s.r.o.

    Praha, 130 00
    Czechia

    Site Not Available

  • Diagnostické centrum Olšanská s.r.o.

    Praha, 13000
    Czechia

    Site Not Available

  • Lekarna Pod Platany

    Praha, 101 00
    Czechia

    Site Not Available

  • Revmatologicky ustav

    Praha 2, 12850
    Czechia

    Site Not Available

  • Fakultni Nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Lekarna Hradebni s.r.o.

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • MEDICAL PLUS s.r.o.

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • Radiodiagnosticka ordinace a pracoviste

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences, Kauno klinikos

    Kaunas, LT-50161
    Lithuania

    Site Not Available

  • Klaipeda University Hospital

    Klaipeda, LT-92288
    Lithuania

    Site Not Available

  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, 15-099
    Poland

    Site Not Available

  • NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik

    Bialystok, 15-351
    Poland

    Site Not Available

  • Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.

    Krakow, 30-002
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, 30-510
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych REUMED

    Lublin, 20-582
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED s.c.

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sol, 67-100
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

    Poznan, 61-397
    Poland

    Site Not Available

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87-100
    Poland

    Site Not Available

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warszawa, 02-118
    Poland

    Site Not Available

  • Limited Liability Company "Clinic on Maroseyka"

    Moscow, 101000
    Russian Federation

    Site Not Available

  • Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

    Orenburg, 460000
    Russian Federation

    Site Not Available

  • GBUZ "Orenburg Regional Clinical Hospital"

    Orenburg, 460018
    Russian Federation

    Site Not Available

  • SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"

    Petrozavodsk, 185910
    Russian Federation

    Site Not Available

  • FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"

    Ryazan, 390026
    Russian Federation

    Site Not Available

  • SBI of Ryazan Region "Regional Clinical Hospital"

    Ryazan, 390039
    Russian Federation

    Site Not Available

  • SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"

    Ryazan, 390026
    Russian Federation

    Site Not Available

  • FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Smolensk Regional Clinical Hospital

    Smolensk, 214018
    Russian Federation

    Site Not Available

  • LLC "BioMed"

    Vladimir, 600005
    Russian Federation

    Site Not Available

  • LLC "Center for Medical Advice and Research-PRACTICE"

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Institute of Rheumatology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute for Treatment and Rehabilitation Niska Banja

    Niska Banja, 18205
    Serbia

    Site Not Available

  • Special Hospital for Rheumatic Diseases Novi Sad

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Emmed Research

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Jakaranda Hospital

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Arthritis Clinical Research Trials

    Cape Town, Western CAPE 7405
    South Africa

    Site Not Available

  • Panorama Medical Centre

    Cape Town, Western CAPE 7500
    South Africa

    Site Not Available

  • Winelands Medical Research Centre

    Stellenbosch, Western CAPE 7600
    South Africa

    Site Not Available

  • Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia

    Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia

    Kharkiv, 61058
    Ukraine

    Site Not Available

  • Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "

    Kyiv, 02081
    Ukraine

    Site Not Available

  • Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia

    M. Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu

    Odesa, 65026
    Ukraine

    Site Not Available

  • Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"

    Odesa, 65025
    Ukraine

    Site Not Available

  • Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

    Vinnytsia, 21028
    Ukraine

    Site Not Available

  • Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady

    Zhytomyr, 10002
    Ukraine

    Site Not Available

  • International Medical Research

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Site Not Available

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