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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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 Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04230213
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bosnia and Herzegovina, Bulgaria, Czechia, Lithuania, Poland, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Treatment Arm 1

Subcutaneous (SC) injection given every other week

Active Comparator: Treatment Arm 2

SC injection given every other week

Interventions

Drug: - PF-06410293

SC injection

Drug: - adalimumab

SC injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Medical Research, Daytona Beach, Florida

Status

Not yet recruiting

Address

International Medical Research

Daytona Beach, Florida, 32117

Graves Gilbert Clinic, Bowling Green, Kentucky

Status

Recruiting

Address

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Rheumatology and Pulmonary Clinic, Beckley, West Virginia

Status

Recruiting

Address

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801

International Sites

Banja Luka, Bosnia and Herzegovina

Status

Not yet recruiting

Address

University Clinical Center of the Republic of Srpska

Banja Luka, , 78000

Health Center Gradiska, Gradiska, Bosnia and Herzegovina

Status

Not yet recruiting

Address

Health Center Gradiska

Gradiska, , 78400

Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina

Status

Not yet recruiting

Address

Clinical Center University of Sarajevo

Sarajevo, , 71000

General Hospital Prim. Dr.Abdulah Nakas, Sarajevo, Bosnia and Herzegovina

Status

Not yet recruiting

Address

General Hospital Prim. Dr.Abdulah Nakas

Sarajevo, , 71000

UMHAT "Dr Georgi Stranski" EAD, Pleven, Bulgaria

Status

Not yet recruiting

Address

UMHAT "Dr Georgi Stranski" EAD

Pleven, , 5800

DCC Sveti Georgi, Plovdiv, Bulgaria

Status

Not yet recruiting

Address

DCC Sveti Georgi

Plovdiv, , 4002

Unimed Medical Centre, Plovdiv, Bulgaria

Status

Not yet recruiting

Address

Unimed Medical Centre

Plovdiv, , 4023

Sofia, Bulgaria

Status

Not yet recruiting

Address

Multiprofile hospital for active treatment - "Lyulin" EAD

Sofia, , 1336

IMEDICA s.r.o., Brno, Czechia

Status

Not yet recruiting

Address

IMEDICA s.r.o.

Brno, , 602 00

Lekarna Na Lidicke, Brno, Czechia

Status

Not yet recruiting

Address

Lekarna Na Lidicke

Brno, , 602 00

Lekarna Biovita, Brno, Czechia

Status

Not yet recruiting

Address

Lekarna Biovita

Brno, , 60200

X-Medica, s.r.o., Brno, Czechia

Status

Not yet recruiting

Address

X-Medica, s.r.o.

Brno, , 613 00

Revmacentrum MUDr. Mostera, s.r.o., Brno, Czechia

Status

Not yet recruiting

Address

Revmacentrum MUDr. Mostera, s.r.o.

Brno, , 615 00

L.K.N. Arthrocentrum, s.r.o., Hlucin, Czechia

Status

Recruiting

Address

L.K.N. Arthrocentrum, s.r.o.

Hlucin, , 748 01

Plicni ambulance, Hlucin, Czechia

Status

Recruiting

Address

Plicni ambulance

Hlucin, , 748 01

Chirurgie Sibenik, Olomouc, Czechia

Status

Not yet recruiting

Address

Chirurgie Sibenik

Olomouc, , 779 00

CTCenter MaVe s.r.o, Olomouc, Czechia

Status

Not yet recruiting

Address

CTCenter MaVe s.r.o

Olomouc, , 779 00

Lekarna u Pottingea, Olomouc, Czechia

Status

Not yet recruiting

Address

Lekarna u Pottingea

Olomouc, , 779 00

Lekarna Vesalion, Ostrava, Czechia

Status

Recruiting

Address

Lekarna Vesalion

Ostrava, , 702 00

CCR Czech a.s., Pardubice, Czechia

Status

Recruiting

Address

CCR Czech a.s.

Pardubice, , 530 02

Lekarna BENU, Pardubice, Czechia

Status

Recruiting

Address

Lekarna BENU

Pardubice, , 530 02

Lekarna Pod Platany, Praha, Czechia

Status

Not yet recruiting

Address

Lekarna Pod Platany

Praha, , 101 00

CCR Prague s.r.o., Praha, Czechia

Status

Not yet recruiting

Address

CCR Prague s.r.o.

Praha, , 130 00

Diagnostické centrum Olšanská s.r.o., Praha, Czechia

Status

Not yet recruiting

Address

Diagnostické centrum Olšanská s.r.o.

Praha, , 13000

Lekarna Hradebni s.r.o., Uherske Hradiste, Czechia

Status

Recruiting

Address

Lekarna Hradebni s.r.o.

Uherske Hradiste, , 68601

MEDICAL PLUS s.r.o., Uherske Hradiste, Czechia

Status

Recruiting

Address

MEDICAL PLUS s.r.o.

Uherske Hradiste, , 68601

Radiodiagnosticka ordinace a pracoviste, Uherske Hradiste, Czechia

Status

Recruiting

Address

Radiodiagnosticka ordinace a pracoviste

Uherske Hradiste, , 68601

Kaunas, Lithuania

Status

Recruiting

Address

Hospital of Lithuanian University of Health Sciences, Kauno klinikos

Kaunas, , LT-50161

Klaipeda University Hospital, Klaipeda, Lithuania

Status

Recruiting

Address

Klaipeda University Hospital

Klaipeda, , LT-92288

Bialystok, Poland

Status

Not yet recruiting

Address

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, , 15-099

Bialystok, Poland

Status

Not yet recruiting

Address

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

Bialystok, , 15-351

Krakow, Poland

Status

Recruiting

Address

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

Krakow, , 30-002

Pratia MCM Krakow, Krakow, Poland

Status

Recruiting

Address

Pratia MCM Krakow

Krakow, , 30-510

Zespol Poradni Specjalistycznych REUMED, Lublin, Poland

Status

Not yet recruiting

Address

Zespol Poradni Specjalistycznych REUMED

Lublin, , 20-582

NZOZ Lecznica MAK-MED s.c., Nadarzyn, Poland

Status

Recruiting

Address

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, , 05-830

Nowa Sol, Poland

Status

Not yet recruiting

Address

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sol, , 67-100

Poznan, Poland

Status

Recruiting

Address

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

Poznan, , 61-397

Nasz Lekarz Przychodnie Medyczne, Torun, Poland

Status

Recruiting

Address

Nasz Lekarz Przychodnie Medyczne

Torun, , 87-100

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warszawa, Poland

Status

Not yet recruiting

Address

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warszawa, , 02-118

Kharkiv, Ukraine

Status

Not yet recruiting

Address

Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia

Kharkiv, , 61058

Kyiv, Ukraine

Status

Not yet recruiting

Address

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

Kyiv, , 03680

Kyiv, Ukraine

Status

Not yet recruiting

Address

Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu "Revmotsentr"

Kyiv, , 04070

Odesa, Ukraine

Status

Not yet recruiting

Address

Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"

Odesa, , 65025

Odesa, Ukraine

Status

Not yet recruiting

Address

Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu

Odesa, , 65026

Zhytomyr, Ukraine

Status

Not yet recruiting

Address

Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady

Zhytomyr, , 10002