Clinical trial NCT01039688: Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Official title: Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: oral JAK inhibitor
MTX
DMARD
clinical trial
joint diseases
autoimmune diseases
anti-Inflammatory agents
rheumatic diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 956
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.


Eligibility criteria: Inclusion Criteria:

* Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL

Exclusion Criteria:

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L
* History of any other rheumatic autoimmune disease other than Sjogren's syndrome
* No malignancy or history of malignancy
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Primary outcomes:
measure: Modified Total Sharp Score (mTSS) at Month 6
timeFrame: Month 6
measure: Change From Baseline at Month 6 in mTSS
timeFrame: Month 6
measure: Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
timeFrame: Month 6
measure: Absolute Blood Pressure (BP) Values (mmHg)
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
measure: Change From Baseline in BP Values (mmHg)
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary outcomes:
measure: mTSS Score at Baseline, Months 12 and 24
timeFrame: Baseline, Months 12 and 24
measure: Change From Baseline in mTSS Score at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
timeFrame: Months 6, 12, and 24
measure: Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
timeFrame: Months 6, 12, and 24
measure: Erosion Scores
timeFrame: Baseline, Months 6, 12, and 24
measure: JSN Scores
timeFrame: Baseline, Months 6, 12, and 24
measure: Change From Baseline in Erosion Scores
timeFrame: Months 6, 12, and 24
measure: Change From Baseline in JSN Scores
timeFrame: Months 6, 12, and 24
measure: Percentage of Participants Achieving an ACR70 Response
timeFrame: Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants Achieving an ACR20 Response
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants Achieving an ACR50 Response
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Tender Joints Count (TJC)
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in TJC
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Swollen Joints Count (SJC)
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in SJC
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Patient Assessment of Arthritis Pain
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in Patient Assessment of Arthritis Pain
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Physician Global Assessment of Arthritis
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in Physician Global Assessment of Arthritis
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Patient Global Assessment of Arthritis
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in Patient Global Assessment of Arthritis
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: C-Reactive Protein
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in CRP
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in DAS28-3(CRP)
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in DAS28-4(ESR)
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-3(CRP) ≤3.2
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-4(ESR) ≤3.2
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-3(CRP) <2.6
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-4(ESR) <2.6
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
timeFrame: Months 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
timeFrame: Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
timeFrame: Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
timeFrame: Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
timeFrame: Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
timeFrame: Months 3, 6, 9, 12, 15, 18, 21, and 24
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in HAQ-DI Score
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Short Form 36 (SF-36) Mental Component Score
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: SF-36 Physical Component Score
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in SF-36 Mental Component Score
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in SF-36 Physical Component Score
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: SF-36 Domain Scores
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in SF-36 Domain Scores
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Work Limitation Questionnaire (WLQ) Score
timeFrame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in WLQ Scores
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: WLQ Work Loss Index Score
timeFrame: Baseline and Months 3, 6, and 12
measure: Change From Baseline in WLQ Work Loss Index Score
timeFrame: Months 3, 6, 12, 15, 18, 21, and 24
measure: European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
timeFrame: Baseline and Months 3, 6, 12, 18, and 24
measure: Change From Baseline in EQ-5D Health State Profile Utility Score
timeFrame: Months 3, 6, 12, 18, and 24
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
timeFrame: Baseline and Months 3 and 6
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6
timeFrame: Baseline and Months 3 and 6
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6
timeFrame: Baseline and Months 3 and 6
measure: Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
timeFrame: Baseline and Months 3 and 6
measure: Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
timeFrame: Baseline, Months 3, 6, 12, 18, and 24
measure: Change From Baseline in Work Productivity and HCRU at Months 3 and 6
timeFrame: Months 3 and 6
measure: Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6
timeFrame: Months 3 and 6
measure: Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
timeFrame: Months 3 and 6
measure: Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
timeFrame: Months 3 and 6
measure: Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
timeFrame: Months 3, 6, 12, 18, and 24
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
timeFrame: Baseline and Months 1, 2, and 3
measure: Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
timeFrame: Months 1, 2, 3, 6, 12, 18, and 24
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
timeFrame: Months 6, 12, 18, and 24
measure: Change From Baseline in MOS-SS at Months 1, 2, and 3
timeFrame: Months 1, 2, and 3
measure: Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
timeFrame: Months 6, 12, 18, and 24
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
timeFrame: Baseline and Months 1, 2, 3, 6, 12, 18, and 24
measure: Change From Baseline in FACIT-Fatigue Scale
timeFrame: Months 1, 2, 3, 6, 12, 18, and 24
measure: Change From Baseline in Heart Rate
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
measure: Change From Baseline in Temperature
timeFrame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Diagnostic Clinic
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego Perlman Ambulatory Clinic
state: California
city: La Jolla
country: United States
facility: University of California San Diego Center for Innovative Therapy
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC, Lower Level Pharmacy
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Gainesville
country: United States
facility: Southeastern Arthritis Center
state: Florida
city: Gainesville
country: United States
facility: Southeastern Imaging and Diagnostics
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL dba Florida Medical Research
state: Florida
city: Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Bernard F. Germain, MD
state: Florida
city: Tampa
country: United States
facility: Burnette & Silverfield, MDS PLC
state: Florida
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research, PC
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinic, PC
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences
state: Louisiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - Rheumatology
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina Investigational Drug Services
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Rheumatology Research
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center at Fort Worth
state: Texas
city: Seattle
country: United States
facility: Investigational Drug Service
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Clarksburg
country: United States
facility: United Hospital Center (Imaging Only)
state: West Virginia
city: Buenos Aires
country: Argentina
facility: OMI - Organización Médica de Investigación
city: Buenos Aires
country: Argentina
facility: Saint Dennis Medical Group S.A.
city: Buenos Aires
country: Argentina
facility: Consultorios Reumatológicos Pampa
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit Sunshine Coast
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital, Department of Rheumatology
state: South Australia
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent - Reumatologie
city: Goiania
country: Brazil
facility: CIP - Centro Internacional de Pesquisas
state: GO
city: Goiania
country: Brazil
facility: Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
state: GO
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
state: SP
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
city: Plovdiv
country: Bulgaria
facility: Revmatologichno Otdelenie, MBAL - Plovdiv
city: Ruse
country: Bulgaria
facility: MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
city: Sofia
country: Bulgaria
facility: MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
city: Sofia
country: Bulgaria
facility: MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
city: Sofia
country: Bulgaria
facility: DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
city: Veliko Tarnovo
country: Bulgaria
facility: MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
city: Edmonton
country: Canada
facility: Rheumatology Research Associates Ltd.
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Burlington
country: Canada
facility: Burlington Rheumatology and Osteoporosis Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Dr. William G. Bensen Medicine Professional Corporation
state: Ontario
city: Hamilton
country: Canada
facility: Office of Dr. Fernando Bianchi
state: Ontario
city: Hamilton
country: Canada
facility: MAC Research Inc.
state: Ontario
city: Kitchener
country: Canada
facility: KW Musculoskeletal Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Rheumatology Research Associates
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Radiological Associates
state: Ontario
city: Windsor
country: Canada
facility: Clinical Research and Arthritis Centre
state: Ontario
city: Temuco
country: Chile
facility: Consulta Privada Dra. Lucia Ponce
state: IX Region
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologicos
state: RM
city: Santiago
country: Chile
facility: Consulta Privada Dra. Marta Aliste
state: RM
city: Vina del Mar
country: Chile
facility: Estudios Clinicos V Region
state: V Region
city: Rancagua
country: Chile
facility: Hospital Regional de Rancagua
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
state: Atlantico
city: Bogota
country: Colombia
facility: Centro Integral de Reumatologia e Inmunologia CIREI
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed E.U
state: Santander
city: Cartago
country: Costa Rica
facility: Centro de Reumatología y Osteoporosis, Cartago
city: San Jose
country: Costa Rica
facility: Hospital Cima San Jose
city: Brno - Zidenice
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Ostrava-Poruba
country: Czechia
facility: Revmatologicka ambulance
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Santo Domingo
country: Dominican Republic
facility: Patricia Alvarez Site
city: Aachen
country: Germany
facility: Privat-Praxis, Rheumatologie (P515)
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Erlangen
country: Germany
facility: Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
city: Halle
country: Germany
facility: Schwerpunktpraxis Rheumatologie FAE Innere Medizin
city: Hamburg
country: Germany
facility: Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
city: Nuernberg
country: Germany
facility: Arztpraxis, Internist - Rheumatologie
city: Ratingen
country: Germany
facility: Rheumaforschung - Studienambulanz Dr. Wassenberg
city: Rheine
country: Germany
facility: Schwerpunktpraxis fuer Rheumatologie
city: Balatonfüred
country: Hungary
facility: Drug Research Center Kft. Reumatologiai Szakrendeles
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Mezokovesd
country: Hungary
facility: Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Hyderabad
country: India
facility: Mahavir Hospital & Research Center
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Department of Rheumatology
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Rheumatic Disease Clinic
state: Gujarat
city: Bangalore
country: India
facility: Shirdi Sai Hospital
state: Karnataka
city: Pune
country: India
facility: Arthritis Research and Care Foundation
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd.
state: Maharashtra
city: Ahmedabad
country: India
facility: Shalby Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Rheumatology, Internal Medicine
city: Seremban
country: Malaysia
facility: Hospital Tuanku Ja'afar
state: Negeri Sembilan
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre
state: Selangor Darul Ehsan
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
state: Coahuila
city: Guadalajara
country: Mexico
facility: Instituto Jaliscience de Investigación Clínica SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Jose Eleuterio Gonzalez
state: Nuevo LEON
city: Otahuhu
country: New Zealand
facility: Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
state: Auckland
city: Christchurch
country: New Zealand
facility: The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
city: Hamilton
country: New Zealand
facility: Ryburns Building, Waikato Hospital
city: Timaru
country: New Zealand
facility: Timaru Hospital, Clinical Trials Unit
city: Callao
country: Peru
facility: Hospital Nacional IV Alberto Sabogal Sologuren
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Centro Medico Corpac
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Davao City
country: Philippines
facility: Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
city: Manila
country: Philippines
facility: Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
city: Gdynia
country: Poland
facility: Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
city: Gdynia
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
city: Katowice
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
city: Warszawa
country: Poland
facility: Synexus SCM Sp. z o.o. Oddzial Warszawa
city: Warszawa
country: Poland
facility: Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
city: Ponce
country: Puerto Rico
facility: Edificio Parra
city: Barnaul
country: Russian Federation
facility: State Healthcare Institution Regional Clinical Hospital
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution
city: Ekaterinburg
country: Russian Federation
facility: Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
city: Ekaterinburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education
city: Kemerovo
country: Russian Federation
facility: State Healthcare Institution Regional Clinical Hospital for War Veterans
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
city: Novosibirsk
country: Russian Federation
facility: Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
city: Saint Petersburg
country: Russian Federation
facility: Almazov Federal Heart, Blood and Endocrinology Centre
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
city: St. Petersburg
country: Russian Federation
facility: State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
city: St. Petersburg
country: Russian Federation
facility: State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
city: Tomsk
country: Russian Federation
facility: Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
city: Bratislava
country: Slovakia
facility: Reumatolog s.r.o.
city: Dunajska Streda
country: Slovakia
facility: AAGS, s.r.o. , nestatne zdravotnicke zariadenie
city: Nove Zamky
country: Slovakia
facility: Reumatologicka ambulancia, Ecclesia, s.r.o.
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Zilina
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Señora de La Esperanza
state: A Coruña
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Malaga
country: Spain
facility: Hospital Civil. Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus i Malmo
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus- Medicinkliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Reumatologmottagningen
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Phayathai
country: Thailand
facility: Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
city: Simferopol
country: Ukraine
facility: CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
state: Crimea
city: Kyiv
country: Ukraine
facility: State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
city: Kyiv
country: Ukraine
facility: State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
city: Lviv
country: Ukraine
facility: Municipal City Clinical Hospital #4, Department of Rheumatology
city: Odesa
country: Ukraine
facility: Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
city: Vinnitsa
country: Ukraine
facility: Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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