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An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate (ORAL STRATEGY)

Primary Purpose

Rhematoid Arthritis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Tofacitinib with methotrexate

Tofacitinib without methotrexate

Adalimumab with methotrexate

About this trial

This is an interventional treatment trial for Rhematoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

Have moderate to severe rheumatoid arthritis
On methotrexate but inadequately controlled
Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
Subjects must use contraception

Exclusion Criteria:

Subjects who have been previously treated with adalimumab or Tofacitinib
Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Subjects with specific laboratory test abnormalities
Subjects with specific types of infections

Sites / Locations

Rheumatology Associates of North Alabama, PC
Arthrocare, Arthritis Care & Research, PC
Medvin Clinical Research
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
HealthCare Partners Medical Group
Keck Medicine of USC - Division of Rheumatology
University of Southern California (USC) Norris Comprehensive Cancer Center
Ronald Reagan UCLA Medical Center - Drug Information Center
UCLA David Geffen School of Medicine, Division of Rheumatology
Medvin Clinical Research
San Diego Arthritis Medical Clinic
Inland Rheumatology Clinical Trials, Inc.
Medvin Clinical Research
Medvin Clinical Research
Joao M. A. Nascimento
AARDS Research, Inc.
Arthritis and Rheumatic Disease Specialties
Riverside Clinical Research
Centre for Rheumatology, Immunology and Arthritis
Jacksonville Center for Clinical Research
Omega Research Consultants, LLC
Arthritis Center, Inc.
Gulf Region Clinical Research Institute Llc
West Broward Rheumatology Associates, Inc.
BayCare Medical Group Inc
The Center for Arthritis and Rheumatism
The Office of Alastair C. Kennedy, MD
Advanced Clinical Research of Orlando, Inc.
Coeur D'Alene Arthritis Clinic
Institute of Arthritis Research
Deerbrook Medical Associates
Diagnostic Rheumatology and Research PC
Ochsner Clinic Baton Rouge
Arthritis and Diabetes Clinic, Inc
Arthritis Treatment Center
Jasper Clinic
Arthritis and Osteoporosis Treatment and Research Center
St. Louis Center For Clinical Research Barbara Caciolo, MD
Clinvest/ A Division of Banyan Group, Inc.
Dr. Prem C. Chatpar M.D.,LLC
PMG Research of Salisbury, LLC
Rowan Diagnostic Clinic
PMG Research of Wilmington
Trinity Health Center - Medical Arts
Lynn Health Science Institute
Altoona Center For Clinical Research
Arthritis Group
Low Country Rheumatology, PA
West Tennessee Research Institute
Accurate Clinical Management, LLC
Arthritis Care And Diagnostic Center, P.A.
Metroplex Clinical Research Center
Accurate Clinical Management, LLC
Rheumatology Clinic of Houston, PA
Houston Institute For Clinical Research
Arthritis & Osteoporosis Associates, LLP
Southwest Rheumatology Research, LLC.
Accurate Clinical Research, Inc.
Arthritis & Osteoporosis Center of South Texas
Arthritis Northwest, PLLC
Atencion Integral en Reumatologia (AIR)
Centro Medico Privado de Reumatologia
Centro Radiologico Luis Mendez Collado SRL
Organizacion Medica de Investigacion S.A - OMI
CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
Royal Prince Alfred Hospital
Pacific Private Clinic
QML Pathology
The Queen Elizabeth Hospital
Emeritus Research
RK Will Pty Ltd
University Hospital Clinical Center Banja Luka
University Clinical Center Tuzla
UMHAT "Dr. Georgi Stranski" EAD
MHAT "Kaspela" EOOD
MHAT EUROHOSPITAL Plovdiv
MHAT Akta Medika OOD
MHAT Ruse AD
MHAT Shumen AD
NMTH Tsar Boris Clinic of Internal Diseases
MHAT Lyulin EAD
MHAT "Targovishte" AD
Kw Musculoskeletal Research Inc
Centre de Recherche Musculo-Squelettique
Prosalud
Estudios Clinicos Quinta Region Ltda.
Quantum Research Ltda
Quantum Research
Revmacentrum MUDr. Mostera, s.r.o.
Revmatologie s.r.o.
Revmatologicka ambulance
Vesalion, s.r.o.
Revmatologie
Foundation Parnu Hospital
East-Tallinn Central Hospital Ltd
North Estonia Medical Centre Foundation
Bnai Zion Medical Center
Rambam Health Care Campus
Hadassah Medical Center
The Chaim Sheba Medical Center
Inha University Hospital
Kyungpook National University Hospital
Daegu Catholic University Medical Center
Chonnam National University Hospital
Hanyang University Seoul Hospital
Konkuk University Medical Center
Health Center 4
ORTO clinic Ltd
Alytaus District S. Kudirkos Hospital
VAKK "Clinic of Dr. Kilda"
PI Republican Siauliai Hospital
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia
Centro Integral en Reumatologia, SA de CV
Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C.
Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan
Departamento de Imagen de Hospital Star Medica Merida
Laboratorio clínico del Hospital Star Medica Merida
Storage for lab kits and study materials
Investigacion y Biomedica de Chihuahua, SC
Centro de Integral en Reumatologia SA de CV
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
Unidad de Investigaciones Reumatologicas A.C.
Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L.
Instituto Peruano del Hueso y la Articulacion
Investigaciones Clinicas S.A.C.
Mary Mediatrix Medical Center
Brokenshire Integrated Health Ministries, Inc.
Iloilo Doctors' Hospital, Inc
University of the Philippines Manila-Philippine General Hospital
Jose R. Reyes Memorial Medical Center-Rayuma Klinik
St. Luke's Medical Center
Far Eastern University - NRMF Medical Center
Perpetual Succour Hospital
Davao Doctors Hospital
St. Paul's Hospital of Iloilo, Inc.
Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow
Centrum Medyczne Amed
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
Centrum Medyczne SILESIANA Sp. z o.o.
Nzoz Bif-Med
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lecznica MAK-MED, NZOZ
Prywatna Praktyka Lekarska
Synexus Polska Sp. z o.o. Oddzial w Warszawie
MTZ Clinical Research Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie
Covamed Serv SRL
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
S.C. Clinica Somesan S.R.L.
Ianuli Med Consult SRL, Reumatologie
Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie
Spitalul Clinic Sf. Maria
Spitalul Clinic "Dr. I. Cantacuzino"
Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia"
Spitalul Clinic Judetean de Urgenta - "Sf.Apostol Andrei" Galati
Spitalul Clinic de Recuperare Iasi
Republic Hospital n.a. V.A. Baranov
State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov"
SAHI of KR "Kemerovo Regional Clinical Hospital"
SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1
CJSC "European Medical Center"
SBEI HPE Novosibirsk State Medical University of MoH of RF
State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"
State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary"
Limited Liability Company AVA-PETER
State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin"
State Institution of Healthcare "Regional Clinical Hospital"
Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways"
State Autonomous Healthcare lnstitution of Yarostavl Region
State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3"
Iatros International
LCS Clinical Research Unit
WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital
WCR: Wits Clinical Research
Charlotte Maxeke Johannesburg Academic Hospital
Clinical Research Unit, University of Pretoria
Netcare Jakaranda Hospital
University of Pretoria
Netcare St Augustine's Hospital
Arthritis Clinical Research Trials
Panorama Medical Centre
Wineland Medical Research Centre
Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario
Complexo Hospitalario Universitario A Coruna
Hospital Clinic de Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Hospital Regional Universitario de Malaga
Hospital Infanta Luisa
Chung Shan Medical University Hospital
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Kaohsiung Medical University Chung-Ho Memorial Hospital - New
Kaohsiung Veterans General Hospital
Taipei Veterans General Hospital
Chang Gung Medical Foundation - Linkou Branch
Phramongkutklao Hospital
Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University
Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,
Siriraj Hospital Mahidol University
Songklanagarind Hospital - Prince of Songkhla University
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg.
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi
Cumhuriyet Universitesi Tip Fakultesi Hastanesi
The Dudley Group NHS Foundation Trust
The Royal Wolverhamptons NHS Trust
The Leeds Teaching Hospitals NHS Trust
Aintree University Hospital NHS Foundation Trust
Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Tofacitinib 5 mg twice daily with methotrexate

Tofacitinib 5 mg twice daily monotherapy

Adalimumab with methotrexate

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6

ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.

Secondary Outcome Measures

Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.

Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6

CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.

Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6

To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).

Percentage of Participants Achieving SDAI ≤3.3 at Month 6

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.

Percentage of Participants Achieving CDAI ≤2.8 at Month 6

Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.

Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.

Percentage of Participants Achieving SDAI ≤11 at Month 6

Percentage of Participants Achieving CDAI ≤10 at Month 6

Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.

Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.

Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6

ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.

Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6

ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6

The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.

Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6

Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6

The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.

Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6

The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.

Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.

Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.

Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.

Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.

Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.

Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.

Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.

Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.

Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6

The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6

The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

Full Information

NCT ID

NCT02187055

First Posted

July 8, 2014

Last Updated

May 29, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02187055

Brief Title

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

Acronym

ORAL STRATEGY

Official Title

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

August 2014 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (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

To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.

6. Conditions and Keywords

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

Rhematoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tofacitinib 5 mg twice daily with methotrexate

Arm Type

Experimental

Arm Title

Tofacitinib 5 mg twice daily monotherapy

Arm Type

Experimental

Arm Title

Adalimumab with methotrexate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tofacitinib with methotrexate

Intervention Description

Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib without methotrexate

Intervention Description

Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Intervention Type

Biological

Intervention Name(s)

Adalimumab with methotrexate

Intervention Description

Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving SDAI ≤3.3 at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving CDAI ≤2.8 at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6

Description

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.

Time Frame

Month 6

Title

Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6

Description

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.

Time Frame

Month 6

Title

Percentage of Participants Achieving SDAI ≤11 at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving CDAI ≤10 at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6

Description

DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.

Time Frame

Month 6

Title

Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6

Description

DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.

Time Frame

Month 6

Title

Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6

Description

Time Frame

Month 6

Title

Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6

Description

The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6

Description

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6

Description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6

Description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6

Description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6

Description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.

Time Frame

Month 6

Title

Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6

Description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.

Time Frame

Month 6

Title

Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6

Description

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have moderate to severe rheumatoid arthritis On methotrexate but inadequately controlled Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection Subjects must use contraception Exclusion Criteria: Subjects who have been previously treated with adalimumab or Tofacitinib Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Subjects with specific laboratory test abnormalities Subjects with specific types of infections

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

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Arthrocare, Arthritis Care & Research, PC

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91722

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

HealthCare Partners Medical Group

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Keck Medicine of USC - Division of Rheumatology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of Southern California (USC) Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Ronald Reagan UCLA Medical Center - Drug Information Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA David Geffen School of Medicine, Division of Rheumatology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Medvin Clinical Research

City

Placentia

State/Province

California

ZIP/Postal Code

92870

Country

United States

Facility Name

San Diego Arthritis Medical Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Medvin Clinical Research

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Medvin Clinical Research

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

Joao M. A. Nascimento

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

AARDS Research, Inc.

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Arthritis and Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Riverside Clinical Research

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

Centre for Rheumatology, Immunology and Arthritis

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Omega Research Consultants, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Arthritis Center, Inc.

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Gulf Region Clinical Research Institute Llc

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32514

Country

United States

Facility Name

West Broward Rheumatology Associates, Inc.

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

BayCare Medical Group Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

The Center for Arthritis and Rheumatism

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

The Office of Alastair C. Kennedy, MD

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Advanced Clinical Research of Orlando, Inc.

City

Winter Garden

State/Province

Florida

ZIP/Postal Code

34787

Country

United States

Facility Name

Coeur D'Alene Arthritis Clinic

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Deerbrook Medical Associates

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

Diagnostic Rheumatology and Research PC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

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

Arthritis Treatment Center

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Jasper Clinic

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

Arthritis and Osteoporosis Treatment and Research Center

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

St. Louis Center For Clinical Research Barbara Caciolo, MD

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Clinvest/ A Division of Banyan Group, Inc.

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Dr. Prem C. Chatpar M.D.,LLC

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

PMG Research of Salisbury, LLC

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Rowan Diagnostic Clinic

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

PMG Research of Wilmington

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

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

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Altoona Center For Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Arthritis Group

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152-3303

Country

United States

Facility Name

Low Country Rheumatology, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Accurate Clinical Management, LLC

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Arthritis Care And Diagnostic Center, P.A.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

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 Management, LLC

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Rheumatology Clinic of Houston, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

Houston Institute For Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Arthritis & Osteoporosis Associates, LLP

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

Southwest Rheumatology Research, LLC.

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Accurate Clinical Research, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Arthritis & Osteoporosis Center of South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Arthritis Northwest, PLLC

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Atencion Integral en Reumatologia (AIR)

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1426AAL

Country

Argentina

Facility Name

Centro Medico Privado de Reumatologia

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Centro Radiologico Luis Mendez Collado SRL

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Organizacion Medica de Investigacion S.A - OMI

City

Buenos Aires

ZIP/Postal Code

1015

Country

Argentina

Facility Name

CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Pacific Private Clinic

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

QML Pathology

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

Emeritus Research

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

RK Will Pty Ltd

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

6100

Country

Australia

Facility Name

University Hospital Clinical Center Banja Luka

City

Banja Luka

State/Province

Republika Srpska

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

University Clinical Center Tuzla

City

Tuzla

ZIP/Postal Code

75000

Country

Bosnia and Herzegovina

Facility Name

UMHAT "Dr. Georgi Stranski" EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

MHAT "Kaspela" EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

MHAT EUROHOSPITAL Plovdiv

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

MHAT Akta Medika OOD

City

Ruse

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

MHAT Ruse AD

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

MHAT Shumen AD

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

NMTH Tsar Boris Clinic of Internal Diseases

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

MHAT Lyulin EAD

City

Sofia

ZIP/Postal Code

1336

Country

Bulgaria

Facility Name

MHAT "Targovishte" AD

City

Targovisthe

ZIP/Postal Code

7700

Country

Bulgaria

Facility Name

Kw Musculoskeletal Research Inc

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Centre de Recherche Musculo-Squelettique

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Prosalud

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7510047

Country

Chile

Facility Name

Estudios Clinicos Quinta Region Ltda.

City

Vina del Mar

State/Province

Valparaiso

ZIP/Postal Code

2520997

Country

Chile

Facility Name

Quantum Research Ltda

City

Puerto Varas

State/Province

X Region

ZIP/Postal Code

5550170

Country

Chile

Facility Name

Quantum Research

City

Puerto Varas

State/Province

X Region

ZIP/Postal Code

5550170

Country

Chile

Facility Name

Revmacentrum MUDr. Mostera, s.r.o.

City

Brno - Zidenice

State/Province

Czech Republic

ZIP/Postal Code

615 00

Country

Czechia

Facility Name

Revmatologie s.r.o.

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Revmatologicka ambulance

City

Ceska Lipa

ZIP/Postal Code

470 01

Country

Czechia

Facility Name

Vesalion, s.r.o.

City

Ostrava- Moravska Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Revmatologie

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Foundation Parnu Hospital

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

East-Tallinn Central Hospital Ltd

City

Tallinn

ZIP/Postal Code

11312

Country

Estonia

Facility Name

North Estonia Medical Centre Foundation

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Bnai Zion Medical Center

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

Rambam Health Care Campus

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

The Chaim Sheba Medical Center

City

Tel-Hashomer

ZIP/Postal Code

5262000

Country

Israel

Facility Name

Inha University Hospital

City

Jung-Gu

State/Province

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Daegu Catholic University Medical Center

City

Daegu

ZIP/Postal Code

42472

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Hanyang University Seoul Hospital

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Health Center 4

City

Riga

ZIP/Postal Code

LV-1012

Country

Latvia

Facility Name

ORTO clinic Ltd

City

Riga

ZIP/Postal Code

LV1005

Country

Latvia

Facility Name

Alytaus District S. Kudirkos Hospital

City

Alytus

ZIP/Postal Code

LT-62114

Country

Lithuania

Facility Name

VAKK "Clinic of Dr. Kilda"

City

Kaunas

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

PI Republican Siauliai Hospital

City

Siauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.

City

Torreon

State/Province

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Centro Integral en Reumatologia, SA de CV

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C.

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Departamento de Imagen de Hospital Star Medica Merida

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Laboratorio clínico del Hospital Star Medica Merida

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Storage for lab kits and study materials

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Investigacion y Biomedica de Chihuahua, SC

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Centro de Integral en Reumatologia SA de CV

City

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

Unidad de Investigaciones Reumatologicas A.C.

City

San Luis Potosi

ZIP/Postal Code

78290

Country

Mexico

Facility Name

Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios

City

Arequipa

ZIP/Postal Code

04020

Country

Peru

Facility Name

ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L.

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Instituto Peruano del Hueso y la Articulacion

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Investigaciones Clinicas S.A.C.

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Mary Mediatrix Medical Center

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Brokenshire Integrated Health Ministries, Inc.

City

Davao

State/Province

Davao DEL SUR

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Iloilo Doctors' Hospital, Inc

City

Iloilo City

State/Province

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

University of the Philippines Manila-Philippine General Hospital

City

Manila

State/Province

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Jose R. Reyes Memorial Medical Center-Rayuma Klinik

City

Manila

State/Province

Metro Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

St. Luke's Medical Center

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Far Eastern University - NRMF Medical Center

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1118

Country

Philippines

Facility Name

Perpetual Succour Hospital

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Davao Doctors Hospital

City

Davao

ZIP/Postal Code

8000

Country

Philippines

Facility Name

St. Paul's Hospital of Iloilo, Inc.

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow

City

Krakow

State/Province

Malopolska

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Centrum Medyczne Amed

City

Warszawa

State/Province

WOJ Mazowieckie

ZIP/Postal Code

01-518

Country

Poland

Facility Name

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

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Centrum Medyczne SILESIANA Sp. z o.o.

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Nzoz Bif-Med

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Gdyni

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Katowicach

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Lecznica MAK-MED, NZOZ

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Prywatna Praktyka Lekarska

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Warszawie

City

Warszawa

ZIP/Postal Code

01192

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400006

Country

Romania

Facility Name

Covamed Serv SRL

City

Sfantu Gheorghe

State/Province

Covasna

ZIP/Postal Code

520052

Country

Romania

Facility Name

Spitalul Judetean de Urgenta "Dr. Constantin Opris"

City

Baia Mare

State/Province

Maramures

ZIP/Postal Code

430031

Country

Romania

Facility Name

S.C. Clinica Somesan S.R.L.

City

Baia Mare

State/Province

Maramures

ZIP/Postal Code

430352

Country

Romania

Facility Name

Ianuli Med Consult SRL, Reumatologie

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Spitalul Clinic Sf. Maria

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Spitalul Clinic "Dr. I. Cantacuzino"

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia"

City

Bucuresti

ZIP/Postal Code

020983

Country

Romania

Facility Name

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

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

Spitalul Clinic de Recuperare Iasi

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Republic Hospital n.a. V.A. Baranov

City

Petrozawodsk

State/Province

Karelia Republic

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov"

City

Petrozawodsk

State/Province

Karelia Republic

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

SAHI of KR "Kemerovo Regional Clinical Hospital"

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

CJSC "European Medical Center"

City

Moscow

ZIP/Postal Code

129090

Country

Russian Federation

Facility Name

SBEI HPE Novosibirsk State Medical University of MoH of RF

City

Novosibirsk

ZIP/Postal Code

630102

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Limited Liability Company AVA-PETER

City

Saint Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin"

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

State Institution of Healthcare "Regional Clinical Hospital"

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways"

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

State Autonomous Healthcare lnstitution of Yarostavl Region

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3"

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

Facility Name

Iatros International

City

Bloemfontein

State/Province

FREE State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

LCS Clinical Research Unit

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2021

Country

South Africa

Facility Name

WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

WCR: Wits Clinical Research

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Charlotte Maxeke Johannesburg Academic Hospital

City

Parktown, Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Clinical Research Unit, University of Pretoria

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Netcare Jakaranda Hospital

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

University of Pretoria

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Netcare St Augustine's Hospital

City

Durban

State/Province

Kwazulu-natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Arthritis Clinical Research Trials

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Panorama Medical Centre

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Wineland Medical Research Centre

City

Stellenbosch

State/Province

Western CAPE

ZIP/Postal Code

7600

Country

South Africa

Facility Name

Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Complexo Hospitalario Universitario A Coruna

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hospital Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Chung Shan Medical University Hospital

City

Taichung

State/Province

Taiwan ROC

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

City

Hualien

ZIP/Postal Code

97002

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital - New

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Medical Foundation - Linkou Branch

City

Taoyuan County

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Phramongkutklao Hospital

City

Bangkok

State/Province

Rajthevi

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Siriraj Hospital Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Songklanagarind Hospital - Prince of Songkhla University

City

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg.

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Cumhuriyet Universitesi Tip Fakultesi Hastanesi

City

Sivas

ZIP/Postal Code

58140

Country

Turkey

Facility Name

The Dudley Group NHS Foundation Trust

City

Dudley

State/Province

WEST Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

The Royal Wolverhamptons NHS Trust

City

Cannock

ZIP/Postal Code

WS11 5XY

Country

United Kingdom

Facility Name

The Leeds Teaching Hospitals NHS Trust

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Aintree University Hospital NHS Foundation Trust

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Royal Free London NHS Foundation Trust

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35232809

Citation

Bessette L, Mysler E, Kinch CD, Kwok K, Lukic T, On PV, van Vollenhoven RF. Impact of Tofacitinib on Components of the ACR Response Criteria: Post Hoc Analysis of Phase III and Phase IIIb/IV Trials. J Rheumatol. 2022 Jun;49(6):566-576. doi: 10.3899/jrheum.210707. Epub 2022 Mar 1.

Results Reference

derived

PubMed Identifier

34921355

Citation

Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

Results Reference

derived

PubMed Identifier

34870800

Citation

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Results Reference

derived

PubMed Identifier

34429160

Citation

Takeuchi T, Fleischmann R, Iikuni N, Shi H, Soma K, Paulissen J, Hirose T, Smolen JS. Differences and similarities in clinical and functional responses among patients receiving tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate: a post hoc analysis of data from ORAL Strategy. Arthritis Res Ther. 2021 Aug 24;23(1):220. doi: 10.1186/s13075-021-02591-y.

Results Reference

derived

PubMed Identifier

33127856

Citation

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Results Reference

derived

PubMed Identifier

32816215

Citation

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Results Reference

derived

PubMed Identifier

31673419

Citation

Strand V, Mysler E, Moots RJ, Wallenstein GV, DeMasi R, Gruben D, Soma K, Iikuni N, Smolen JS, Fleischmann R. Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019.

Results Reference

derived

PubMed Identifier

31207152

Citation

Calabrese LH, Abud-Mendoza C, Lindsey SM, Lee SH, Tatulych S, Takiya L, Iikuni N, Soma K, Luo Z, Fleischmann R. Live Zoster Vaccine in Patients With Rheumatoid Arthritis Treated With Tofacitinib With or Without Methotrexate, or Adalimumab With Methotrexate: A Post Hoc Analysis of Data From a Phase IIIb/IV Randomized Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):353-359. doi: 10.1002/acr.24010.

Results Reference

derived

PubMed Identifier

28629665

Citation

Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya L, Tatulych S, Mojcik C, Krishnaswami S, Menon S, Smolen JS; ORAL Strategy investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5. Epub 2017 Jun 16.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921187&StudyName=An%20Efficacy%20And%20Safety%20Study%20Evaluating%20Tofacitinib%20With%20And%20Without%20Methotrexate%20Compared%20To%20Adalimumab%20With%20Methotrexate

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

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