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A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PF-06438179

Infliximab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Phase 3, infliximab, rheumatoid arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Achieve Clinical Research, LLC
Clinical and Translational Research Center of Alabama, PC
Sun Valley Arthritis Center, Ltd.
Arizona Arthritis & Rheumatology Associates, P.C.
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Arthritis & Osteoporosis Medical Center
Inland Rheumatology Clinical Trials, Inc.
Desert Valley Medical Group
Javed Rheumatology Associates, Inc
Arthritis and Rheumatic Disease Specialties
International Medical Research
San Marcus Research Clinic, Inc.
Advance Medical Research Services Corporation
Sarasota Arthritis Research Center
Alastair C. Kennedy, MD
Indian River Primary Care
Harbin Clinic
Advanced Clinical Research
Methodist Medical Center of IL
Physician's Clinic of Iowa, P.C.
Gilbert-Graves Clinic
Graves-Gilbert Clinic Bowling Green
Ochsner Clinic Baton Rouge
Arthritis and Diabetes Clinic, Inc.
The Center for Rheumatology and Bone Research
Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research
Arthritis, Rheumatic & Back Disease Associates
Trinity Health Center-Medical Arts
Altoona Center for Clinical Research
Clinical Research Center of Reading, LLC
Low Country Rheumatology, PA
Regional Health Clinical Research
Regional Medical Clinic
West Tennessee Research Institute
Ramesh C Gupta, MD
Austin Regional Clinic
Metroplex Clinical Research Center
Accurate Clinical Research, Inc.
Accurate Clinical Research
Pharmacy Services, Sentara Leigh Hospital
Sentara Medical Group, Clinical Research
The Seattle Arthritis Clinic
Gold Coast Private Hospital Pty Ltd
HPS Pharmacies
Paradise Arthritis and Rheumatology Pty Ltd
The Queen Elizabeth Hospital
CliniPath Pathology
R.K. Will Pty Ltd
Clinical Center University of Sarajevo
General Hospital "Prim.dr.Abdulah Nakas"
University Clinical Center Tuzla
University Hospital Clinical Center Banja Luka
CETI - Centro de Estudos em Terapias Inovadoras
Hospital Israelita Albert Einstein
Multiprofile Hospital for Active Treatment Trimontium OOD
University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD
University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD
Clinical Research and Arthritis Center
CCBR Czech Brno, s.r.o.
Lekarna Lancier, s.r.o.
BENU Lekarna
CCBR-SYNARC a.s.
CCBR Czech Prague, s.r.o.
Lekarna U Robina, s.r.o.
Lekarna Hradebni s.r.o.
MEDICAL PLUS, s.r.o.
LTD Tbilisi Central Hospital
LTD Unimedi Kakheti
Tbilisi Heart and Vascular Clinic LTD
LTD MediClubGeorgia
LTD Adapti
LTD Medulla" Chemotherapy and Immunotherapy Clinic
Schlosspark-Klinik
Klinikum der Universität München
Elisabeth-Klinik gGmbH
Knappschaftsklinikum Saar GmbH
Rheumazentrum Ratingen
Clínica Médica Especializada en Medicina Interna y Reumatología
Clínica Médica especializada en Medicina Interna
Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)
Therapeutic Research Institute and Lab S.A
DRC Gyógyszervizsgáló Központ Kft.
Qualiclinic Kft.
Rambam Health Care Campus
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Meir Medical Center
Anjo Kosei Hospital
Aso Iizuka Hospital
Inoue Hospital
Mazda Hospital
Sapporo City General Hospital
Hokkaido University Hospital
Matsubara Mayflower Hospital
National Hospital Organization Sagamihara National Hospital
Yokohama Minami Kyosai Hospital
National Hospital Organization Nagasaki Medical Center
Sasebo Chuo Hospital
Kurashiki Sweet Hospital
Yuaikai Tomishiro Central Hospital
Saitama Medical Center
Hirose Clinic
National Hospital Organization Shizuoka Medical Center
St. Luke's International Hospital
Toho University Ohashi Medical Center
Showa University Hospital
National Hospital Organization Chiba-East Hospital
Kondo clinic for rheumatism and orthopaedics
National Hospital Organization Kyushu Medical Center
Kumamoto Orthopaedic Hospital
Jordan Hospital
King Abdullah University Hospital
Chungnam National University Hospital
Chonnam National University Hospital
Seoul National University Hospital
Hanyang University Seoul Hospital
Severance Hospital, Yonsei University Health System
Konkuk University Medical Center
LSMUL Kauno klinikos
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"
Unidad Reumatologica Las Americas S.C.P
El Ayachi Hospital
Groupe Radiologique de Salé
Laboratoire les Arcades d'Analyses Médicales
Hospital María Auxiliadora - Centro de Investigaciones Medicas
Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
Centro de diagnóstico por imágenes, Radiología General y Especial
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
Centro de Investigación Reumatología CAA
Clinica Medica Cayetano Heredia
Servicio de Inmunología y Reumatología
Mary Mediatrix Medical Center
Southern Philippines Medical Center
Makati Medical Center
Medical Center Manila
Philippine General Hospital
St. Luke's Medical Center
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji
NZOZ Lecznica MAK-MED. S.C.
Twoja Przychodnia - Centrum Medyczne Nowa Sol
MTZ Clinical Research Sp. z o.o.
Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"
Spitalul Clinic de Recuperare Iasi
Spitalul Clinic Judetean de Urgenta Targu Mures
GBUZ "Republican hospital n.a. V.A.Baranov"
GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"
Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky
GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region
GBUZ of city of Moscow
GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"
GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"
GBU of Ryazan region "Regional clinical cardiology dispanser"
GBOU of Ryazan region "Regional clinical hospital"
Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis
GUZ "Regional clinical hospital"
GBUZ VO 'Regional clinical hospital"
GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"
Clinical Hospital Center Bezanijska Kosa
Military Medical Academy
Institute for Treatment and Rehabilitation "Niska Banja"
Charlotte Maxeke Johannesburg Academic Hospital
Jakaranda Hospital
Emmed Research
Arthritis Clinical Research Unit
Vincent Pallotti Hospital
Mohamed Kassab Institute of orthopedics
Rabta Hospital
Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut
Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad
Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
Khmelnytska oblasna likarnia
Kyivska miska klinichna likarnia #6
Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy
Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"
Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"
Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne
Komunalna ustanova "Odeska oblasna klinichna likarnia"
Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
Wrightington Hospital
Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PF-06438179

Infliximab

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).

Secondary Outcome Measures

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

ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3

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

ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.

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

Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3

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

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1

ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2

ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1

EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1

AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3

Number of Participants With Laboratory Abnormalities: Period 1

Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.

Number of Participants With Laboratory Abnormalities: Period 2

Number of Participants With Laboratory Abnormalities: Period 3

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3

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

PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Serum Concentration Versus Time Summary: Period 1

Serum Concentration Versus Time Summary: Period 2

Serum Concentration Versus Time Summary: Period 3

Full Information

NCT ID

NCT02222493

First Posted

August 19, 2014

Last Updated

April 30, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02222493

Brief Title

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 26, 2014 (Actual)

Primary Completion Date

June 29, 2016 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Phase 3, infliximab, rheumatoid arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

650 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06438179

Arm Type

Experimental

Arm Title

Infliximab

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

PF-06438179

Other Intervention Name(s)

Infliximab-Pfizer

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Infliximab

Other Intervention Name(s)

Infliximab-EU, Remicade

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

Description

Time Frame

Week 14

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 2, 4, 6, 12, 22 and 30 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2

Description

Time Frame

Week 38, 46 and 54 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3

Description

Time Frame

Week 62, 70 and 78

Title

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

Description

Time Frame

Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)

Title

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

Description

Time Frame

Week 38, 46 and 54 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3

Description

Time Frame

Week 62, 70 and 78

Title

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

Description

Time Frame

Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Title

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2

Description

Time Frame

Baseline (Week 30 pre-dose), Week 38, 46 and 54

Title

Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3

Description

Time Frame

Baseline (Week 54 pre-dose), Week 62, 70 and 78

Title

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1

Description

Time Frame

Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Title

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2

Description

Time Frame

Week 38, 46 and 54 (pre-dose)

Title

Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3

Description

Time Frame

Week 62, 70 and 78

Title

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1

Description

Time Frame

Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Title

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2

Description

Time Frame

Week 38, 46 and Week 54 (pre-dose)

Title

Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3

Description

Time Frame

Week 62, 70 and Week 78

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

Description

Time Frame

Baseline (Day 1) up to Week 30

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Time Frame

Baseline (Week 30 pre-dose) up to Week 54

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Time Frame

Baseline (Week 54 pre-dose) up to Week 78

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1

Description

Time Frame

Baseline (Day 1) up to Week 30

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2

Description

Time Frame

Baseline (Week 30 pre-dose) up to Week 54

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3

Description

Time Frame

Baseline (Week 54 pre-dose) up to Week 78

Title

Number of Participants With Laboratory Abnormalities: Period 1

Description

Time Frame

Baseline (Day 1) up to Week 30

Title

Number of Participants With Laboratory Abnormalities: Period 2

Description

Time Frame

Baseline (Week 30 pre-dose) up to Week 54

Title

Number of Participants With Laboratory Abnormalities: Period 3

Description

Time Frame

Baseline (Week 54 pre-dose) up to Week 78

Title

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

Description

Time Frame

Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30

Title

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2

Description

Time Frame

Baseline (Week 30 pre-dose), Week 38, 46 and Week 54

Title

Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3

Description

Time Frame

Baseline (Week 54 pre-dose), Week 62, 70 and 78

Title

Description

Time Frame

Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Title

Description

Time Frame

Baseline (Week 30 pre-dose), Week 38, 46 and 54

Title

Description

Time Frame

Baseline (Week 54 pre-dose), Week 62, 70 and 78

Title

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1

Time Frame

Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Title

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2

Time Frame

Baseline (Week 30 pre-dose), Week 38, 46 and 54

Title

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3

Time Frame

Baseline (Week 54 pre-dose), Week 62, 70 and 78

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1

Description

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Time Frame

Baseline (Day 1) up to Week 30

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2

Description

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Time Frame

Baseline (Week 30 pre-dose) up to Week 54

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3

Description

ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.

Time Frame

Baseline (Week 54 pre-dose) up to Week 78

Title

Serum Concentration Versus Time Summary: Period 1

Time Frame

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

Title

Serum Concentration Versus Time Summary: Period 2

Time Frame

Pre dose on Day 211, 267, 379 and 547

Title

Serum Concentration Versus Time Summary: Period 3

Time Frame

Pre dose on Day 379, 435 and 547

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Achieve Clinical Research, LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Clinical and Translational Research Center of Alabama, PC

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Sun Valley Arthritis Center, Ltd.

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Arthritis & Osteoporosis Medical Center

City

La Palma

State/Province

California

ZIP/Postal Code

90623

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Desert Valley Medical Group

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

Javed Rheumatology Associates, Inc

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Arthritis and Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

International Medical Research

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

San Marcus Research Clinic, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Advance Medical Research Services Corporation

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Sarasota Arthritis Research Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Alastair C. Kennedy, MD

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Indian River Primary Care

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Harbin Clinic

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

Advanced Clinical Research

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Methodist Medical Center of IL

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61636

Country

United States

Facility Name

Physician's Clinic of Iowa, P.C.

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52403

Country

United States

Facility Name

Gilbert-Graves Clinic

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Graves-Gilbert Clinic Bowling Green

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Ochsner Clinic Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Arthritis and Diabetes Clinic, Inc.

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

The Center for Rheumatology and Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

Arthritis, Rheumatic & Back Disease Associates

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Trinity Health Center-Medical Arts

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Clinical Research Center of Reading, LLC

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Low Country Rheumatology, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Regional Health Clinical Research

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Regional Medical Clinic

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Ramesh C Gupta, MD

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Accurate Clinical Research, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Accurate Clinical Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Pharmacy Services, Sentara Leigh Hospital

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Sentara Medical Group, Clinical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

The Seattle Arthritis Clinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Gold Coast Private Hospital Pty Ltd

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

HPS Pharmacies

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Paradise Arthritis and Rheumatology Pty Ltd

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

The Queen Elizabeth Hospital

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

CliniPath Pathology

City

Osborne Park

State/Province

Western Australia

ZIP/Postal Code

6017

Country

Australia

Facility Name

R.K. Will Pty Ltd

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

6100

Country

Australia

Facility Name

Clinical Center University of Sarajevo

City

Sarajevo

State/Province

Kanton Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

General Hospital "Prim.dr.Abdulah Nakas"

City

Sarajevo

State/Province

Kanton Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

University Clinical Center Tuzla

City

Tuzla

State/Province

Tuzlanski Kanton

ZIP/Postal Code

75000

Country

Bosnia and Herzegovina

Facility Name

University Hospital Clinical Center Banja Luka

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

CETI - Centro de Estudos em Terapias Inovadoras

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

Hospital Israelita Albert Einstein

City

São Paulo

ZIP/Postal Code

05652-900

Country

Brazil

Facility Name

Multiprofile Hospital for Active Treatment Trimontium OOD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Clinical Research and Arthritis Center

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 2C9

Country

Canada

Facility Name

CCBR Czech Brno, s.r.o.

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Lekarna Lancier, s.r.o.

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

BENU Lekarna

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCBR-SYNARC a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCBR Czech Prague, s.r.o.

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Lekarna U Robina, s.r.o.

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Lekarna Hradebni s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

MEDICAL PLUS, s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

LTD Tbilisi Central Hospital

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

LTD Unimedi Kakheti

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Tbilisi Heart and Vascular Clinic LTD

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

LTD MediClubGeorgia

City

Tbilisi

ZIP/Postal Code

0160

Country

Georgia

Facility Name

LTD Adapti

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Facility Name

LTD Medulla" Chemotherapy and Immunotherapy Clinic

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Facility Name

Schlosspark-Klinik

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Klinikum der Universität München

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Elisabeth-Klinik gGmbH

City

Olsberg

ZIP/Postal Code

59939

Country

Germany

Facility Name

Knappschaftsklinikum Saar GmbH

City

Puettlingen

ZIP/Postal Code

66346

Country

Germany

Facility Name

Rheumazentrum Ratingen

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Clínica Médica Especializada en Medicina Interna y Reumatología

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Clínica Médica especializada en Medicina Interna

City

Guatemala

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Therapeutic Research Institute and Lab S.A

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

DRC Gyógyszervizsgáló Központ Kft.

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Rambam Health Care Campus

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Meir Medical Center

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Anjo Kosei Hospital

City

Anjo-shi

State/Province

Aichi

ZIP/Postal Code

446-8602

Country

Japan

Facility Name

Aso Iizuka Hospital

City

Iiduka

State/Province

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

Inoue Hospital

City

Takasaki

State/Province

Gunma

ZIP/Postal Code

370-0053

Country

Japan

Facility Name

Mazda Hospital

City

Aki-gun

State/Province

Hiroshima

ZIP/Postal Code

735-8585

Country

Japan

Facility Name

Sapporo City General Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

Facility Name

Hokkaido University Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Matsubara Mayflower Hospital

City

Katoh

State/Province

Hyogo

ZIP/Postal Code

673-1462

Country

Japan

Facility Name

National Hospital Organization Sagamihara National Hospital

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Yokohama Minami Kyosai Hospital

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0037

Country

Japan

Facility Name

National Hospital Organization Nagasaki Medical Center

City

Omura

State/Province

Nagasaki

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

Sasebo Chuo Hospital

City

Sasebo

State/Province

Nagasaki

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

Kurashiki Sweet Hospital

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-0016

Country

Japan

Facility Name

Yuaikai Tomishiro Central Hospital

City

Tomigusuku

State/Province

Okinawa

ZIP/Postal Code

901-0243

Country

Japan

Facility Name

Saitama Medical Center

City

Kawagoe-shi

State/Province

Saitama

ZIP/Postal Code

350-8550

Country

Japan

Facility Name

Hirose Clinic

City

Tokorozawa-shi

State/Province

Saitama

ZIP/Postal Code

359-1111

Country

Japan

Facility Name

National Hospital Organization Shizuoka Medical Center

City

Sunto-gun

State/Province

Shizuoka

ZIP/Postal Code

411-8611

Country

Japan

Facility Name

St. Luke's International Hospital

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Toho University Ohashi Medical Center

City

Meguro-ku

State/Province

Tokyo

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

Showa University Hospital

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

National Hospital Organization Chiba-East Hospital

City

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

Kondo clinic for rheumatism and orthopaedics

City

Fukuoka

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

National Hospital Organization Kyushu Medical Center

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

Kumamoto Orthopaedic Hospital

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Jordan Hospital

City

Amman

ZIP/Postal Code

11152

Country

Jordan

Facility Name

King Abdullah University Hospital

City

Irbid

ZIP/Postal Code

22110

Country

Jordan

Facility Name

Chungnam National University Hospital

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Hanyang University Seoul Hospital

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

LSMUL Kauno klinikos

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

City

San Luis De Potosí

State/Province

SAN LUIS DE Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"

City

Zona Universitaria

State/Province

SAN LUIS DE Potosi

ZIP/Postal Code

CP 78240

Country

Mexico

Facility Name

Unidad Reumatologica Las Americas S.C.P

City

Merida

State/Province

Yucatan

ZIP/Postal Code

CP 97000

Country

Mexico

Facility Name

El Ayachi Hospital

City

Salé

ZIP/Postal Code

11150

Country

Morocco

Facility Name

Groupe Radiologique de Salé

City

Salé

ZIP/Postal Code

11150

Country

Morocco

Facility Name

Laboratoire les Arcades d'Analyses Médicales

City

Salé

ZIP/Postal Code

11150

Country

Morocco

Facility Name

Hospital María Auxiliadora - Centro de Investigaciones Medicas

City

San juan de Miraflores

State/Province

Lima

ZIP/Postal Code

Lima 29

Country

Peru

Facility Name

Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Centro de diagnóstico por imágenes, Radiología General y Especial

City

Arequipa

ZIP/Postal Code

CP656

Country

Peru

Facility Name

Unidad de Investigación en Medicina Interna y Enfermedades Críticas

City

Arequipa

ZIP/Postal Code

CP656

Country

Peru

Facility Name

Centro de Investigación Reumatología CAA

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

Clinica Medica Cayetano Heredia

City

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

Servicio de Inmunología y Reumatología

City

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

Mary Mediatrix Medical Center

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217/043

Country

Philippines

Facility Name

Southern Philippines Medical Center

City

Davao

State/Province

Davao DEL SUR

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Makati Medical Center

City

Makati

State/Province

Metro Manila

ZIP/Postal Code

1229

Country

Philippines

Facility Name

Medical Center Manila

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Philippine General Hospital

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

St. Luke's Medical Center

City

Quezon

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji

City

Krakow

ZIP/Postal Code

31-121

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED. S.C.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Twoja Przychodnia - Centrum Medyczne Nowa Sol

City

Nowa Sol

ZIP/Postal Code

67-100

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

Spitalul Clinic de Recuperare Iasi

City

Iasi

ZIP/Postal Code

700656

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Targu Mures

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

GBUZ "Republican hospital n.a. V.A.Baranov"

City

Petrozavodsk

State/Province

Republic OF Karelia

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"

City

Krasnoyarsk

ZIP/Postal Code

660014

Country

Russian Federation

Facility Name

Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

GBUZ of city of Moscow

City

Moscow

ZIP/Postal Code

129327

Country

Russian Federation

Facility Name

GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GBU of Ryazan region "Regional clinical cardiology dispanser"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GBOU of Ryazan region "Regional clinical hospital"

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

GUZ "Regional clinical hospital"

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

GBUZ VO 'Regional clinical hospital"

City

Vladimir

ZIP/Postal Code

600023

Country

Russian Federation

Facility Name

GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Clinical Hospital Center Bezanijska Kosa

City

Belgrade

ZIP/Postal Code

11 000

Country

Serbia

Facility Name

Military Medical Academy

City

Belgrade

ZIP/Postal Code

11 000

Country

Serbia

Facility Name

Institute for Treatment and Rehabilitation "Niska Banja"

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Charlotte Maxeke Johannesburg Academic Hospital

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Jakaranda Hospital

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Emmed Research

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Arthritis Clinical Research Unit

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Vincent Pallotti Hospital

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Mohamed Kassab Institute of orthopedics

City

Manouba

ZIP/Postal Code

2010

Country

Tunisia

Facility Name

Rabta Hospital

City

Tunis

ZIP/Postal Code

1007

Country

Tunisia

Facility Name

Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Khmelnytska oblasna likarnia

City

Khmelnytskyi

ZIP/Postal Code

29000

Country

Ukraine

Facility Name

Kyivska miska klinichna likarnia #6

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy

City

Lviv

ZIP/Postal Code

79014

Country

Ukraine

Facility Name

Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"

City

M. Kryvyi Rih

ZIP/Postal Code

50056

Country

Ukraine

Facility Name

Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"

City

M. Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne

City

M. Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Komunalna ustanova "Odeska oblasna klinichna likarnia"

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Wrightington Hospital

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 9EP

Country

United Kingdom

Facility Name

Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust

City

Maidstone

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36180101

Citation

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.

Results Reference

derived

PubMed Identifier

31939063

Citation

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.

Results Reference

derived

PubMed Identifier

31284794

Citation

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.

Results Reference

derived

PubMed Identifier

30997153

Citation

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.

Results Reference

derived

PubMed Identifier

30053896

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5371002&StudyName=A%20Study%20of%20PF-06438179%20%28Infliximab-Pfizer%29%20and%20Infliximab%20in%20Combination%20with%20Methotrexate%20in%20Subjects%20with%20Active%20Rheumatoid%20Arthritis%20

Description

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Learn more about this trial

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

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