Back to resultsComparing 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 (ORAL1069)
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
Disease-modifying antirheumatic drug
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring oral JAK inhibitor, MTX, DMARD, clinical trial, joint diseases, autoimmune diseases, anti-Inflammatory agents, rheumatic diseases
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
Sites / Locations
- Catalina Pointe Clinical Research, Inc.
- Little Rock Diagnostic Clinic
- University of California San Diego Perlman Ambulatory Clinic
- University of California San Diego Center for Innovative Therapy
- Keck Hospital of USC, Lower Level Pharmacy
- Keck Hospital of USC
- USC Keck School of Medicine
- University of California Los Angeles (UCLA)
- Southeastern Arthritis Center
- Southeastern Imaging and Diagnostics
- Southeastern Integrated Medical, PL dba Florida Medical Research
- Center for Arthritis and Rheumatic Diseases
- Sarasota Arthritis Research Center
- West Broward Rheumatology Associates, Inc.
- Bernard F. Germain, MD
- Burnette & Silverfield, MDS PLC
- Diagnostic Rheumatology and Research, PC
- Medical Associates Clinic, PC
- Louisiana State University Health Sciences
- The Center for Rheumatology and Bone Research
- Clinical Pharmacology Study Group
- Physician Research Collaboration, LLC
- The Center for Rheumatology
- AAIR Research Center
- PMG Research of Hickory, LLC
- PMG Research of Hickory, LLC
- Lynn Health Science Institute
- Altoona Center for Clinical Research
- Clinical Research Center of Reading, LLP
- Medical University of South Carolina - Rheumatology
- Medical University of South Carolina Investigational Drug Services
- Medical University of South Carolina
- Arthritis Clinic
- West Tennessee Research Institute
- Austin Rheumatology Research
- Metroplex Clinical Research Center
- University of North Texas Health Science Center at Fort Worth
- Investigational Drug Service
- Virginia Mason Medical Center
- Mountain State Clinical Research
- United Hospital Center (Imaging Only)
- OMI - Organización Médica de Investigación
- Saint Dennis Medical Group S.A.
- Consultorios Reumatológicos Pampa
- Rheumatology Research Unit Sunshine Coast
- The Queen Elizabeth Hospital, Department of Rheumatology
- Emeritus Research
- Universitair Ziekenhuis Gent - Reumatologie
- CIP - Centro Internacional de Pesquisas
- Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
- Centro de Estudos em Terapias Inovadoras
- Hospital Sao Lucas da PUCRS
- CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
- CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
- Revmatologichno Otdelenie, MBAL - Plovdiv
- MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
- MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
- MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
- DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
- MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
- Rheumatology Research Associates Ltd.
- PerCuro Clinical Research Ltd.
- Manitoba Clinic
- Burlington Rheumatology and Osteoporosis Clinic
- Dr. William G. Bensen Medicine Professional Corporation
- Office of Dr. Fernando Bianchi
- MAC Research Inc.
- KW Musculoskeletal Research Inc.
- Rheumatology Research Associates
- Niagara Peninsula Arthritis Centre
- Windsor Radiological Associates
- Clinical Research and Arthritis Centre
- Consulta Privada Dra. Lucia Ponce
- Centro de Estudios Reumatologicos
- Consulta Privada Dra. Marta Aliste
- Estudios Clinicos V Region
- Hospital Regional de Rancagua
- Centro de Reumatologia y Ortopedia
- Centro Integral de Reumatologia e Inmunologia CIREI
- Servimed E.U
- Centro de Reumatología y Osteoporosis, Cartago
- Hospital Cima San Jose
- Revmacentrum MUDr. Mostera, s.r.o.
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- Revmatologicka ambulance
- Revmatologicky ustav
- Revmatologicka ambulance
- Patricia Alvarez Site
- Privat-Praxis, Rheumatologie (P515)
- Schlosspark-Klinik
- Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
- Schwerpunktpraxis Rheumatologie FAE Innere Medizin
- Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
- Arztpraxis, Internist - Rheumatologie
- Rheumaforschung - Studienambulanz Dr. Wassenberg
- Schwerpunktpraxis fuer Rheumatologie
- Drug Research Center Kft. Reumatologiai Szakrendeles
- Revita Reumatologiai Rendelo
- Synexus Magyarorszag Kft.
- Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
- MAV Korhaz es Rendelointezet
- Mahavir Hospital & Research Center
- Department of Rheumatology
- Rheumatic Disease Clinic
- Shirdi Sai Hospital
- Arthritis Research and Care Foundation
- Jehangir Clinical Development Centre Pvt. Ltd.
- Shalby Hospital
- Seoul National University Hospital, Rheumatology, Internal Medicine
- Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
- Asan Medical Center, Rheumatology, Internal Medicine
- Hospital Tuanku Ja'afar
- Sunway Medical Centre
- Sarawak General Hospital
- Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
- Instituto Jaliscience de Investigación Clínica SA de CV
- Unidad de Investigacion en Enfermedades Cronico Degenerativas
- Hospital Universitario Jose Eleuterio Gonzalez
- Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
- The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
- Ryburns Building, Waikato Hospital
- Timaru Hospital, Clinical Trials Unit
- Hospital Nacional IV Alberto Sabogal Sologuren
- Clinica Anglo Americana
- Centro Medico Corpac
- Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
- Chong Hua Hospital
- Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
- Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
- Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
- Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
- Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
- Synexus SCM Sp. z o.o. Oddzial Warszawa
- Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
- Ponce School of Medicine
- Edificio Parra
- State Healthcare Institution Regional Clinical Hospital
- State Healthcare Institution
- Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
- State Educational Institution of Higher Professional Education
- State Healthcare Institution Regional Clinical Hospital for War Veterans
- Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
- Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
- Almazov Federal Heart, Blood and Endocrinology Centre
- Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
- State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
- Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
- State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
- St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
- Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
- Reumatolog s.r.o.
- AAGS, s.r.o. , nestatne zdravotnicke zariadenie
- Reumatologicka ambulancia, Ecclesia, s.r.o.
- Narodny ustav reumatickych chorob
- Nestatna reumatologicka ambulancia
- Hospital Nuestra Señora de La Esperanza
- Hospital de Basurto
- Hospital General Universitario Gregorio Maranon
- Hospital Civil. Hospital Regional Universitario Carlos Haya
- Hospital Universitario Virgen Macarena
- Skanes Universitetssjukhus i Malmo
- Sundsvalls sjukhus- Medicinkliniken
- Akademiska sjukhuset, Reumatologmottagningen
- Chung-Ho Memorial Hospital, Kaohsiung Medical University
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
- Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
- Siriraj Hospital, Mahidol University
- CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
- State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
- State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
- Municipal City Clinical Hospital #4, Department of Rheumatology
- Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
- Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
5 mg BID CP-690,550
10 mg BID CP-690,550
methotrexate
Arm Description
Outcomes
Primary Outcome Measures
Modified Total Sharp Score (mTSS) at Month 6
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Change From Baseline at Month 6 in mTSS
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).
Absolute Blood Pressure (BP) Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Change From Baseline in BP Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Secondary Outcome Measures
mTSS Score at Baseline, Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Change From Baseline in mTSS Score at Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Change From Baseline in Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Percentage of Participants Achieving an ACR70 Response
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants Achieving an ACR20 Response
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants Achieving an ACR50 Response
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Tender Joints Count (TJC)
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Change From Baseline in TJC
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Swollen Joints Count (SJC)
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Change From Baseline in SJC
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Change From Baseline in Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Physician Global Assessment of Arthritis
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Change From Baseline in Physician Global Assessment of Arthritis
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Patient Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Change From Baseline in Patient Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
C-Reactive Protein
CRP measured in milligrams per liter (mg/L)
Change From Baseline in CRP
Change from Baseline in CRP measured in mg/L.
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Change From Baseline in DAS28-3(CRP)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Change From Baseline in DAS28-4(ESR)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Percentage of Participants With DAS28-3(CRP) ≤3.2
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Percentage of Participants With DAS28-4(ESR) ≤3.2
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Percentage of Participants With DAS28-3(CRP) <2.6
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Percentage of Participants With DAS28-4(ESR) <2.6
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Change From Baseline in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Short Form 36 (SF-36) Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Change From Baseline in SF-36 Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Change From Baseline in SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
SF-36 Domain Scores
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change From Baseline in SF-36 Domain Scores
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Work Limitation Questionnaire (WLQ) Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Change From Baseline in WLQ Scores
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
Change From Baseline in WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
EQ-5D: 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"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change From Baseline in EQ-5D Health State Profile Utility Score
EQ-5D: 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"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Change From Baseline in Work Productivity and HCRU at Months 3 and 6
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Change From Baseline in MOS-SS at Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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). A higher score reflected an improvement in the participant's health status
Change From Baseline in FACIT-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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). A higher score reflected an improvement in the participant's health status
Change From Baseline in Heart Rate
Change From Baseline in Temperature
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01039688
Brief Title
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
Acronym
ORAL1069
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
oral JAK inhibitor, MTX, DMARD, clinical trial, joint diseases, autoimmune diseases, anti-Inflammatory agents, rheumatic diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
956 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 mg BID CP-690,550
Arm Type
Experimental
Arm Title
10 mg BID CP-690,550
Arm Type
Experimental
Arm Title
methotrexate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Oral tablets administered at a dose of 5 mg BID for 24 months
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Oral tablets administered at a dose of 10 mg BID for 24 months
Intervention Type
Drug
Intervention Name(s)
Disease-modifying antirheumatic drug
Other Intervention Name(s)
DMARD, MTX
Intervention Description
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Primary Outcome Measure Information:
Title
Modified Total Sharp Score (mTSS) at Month 6
Description
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time Frame
Month 6
Title
Change From Baseline at Month 6 in mTSS
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame
Month 6
Title
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
Description
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).
Time Frame
Month 6
Title
Absolute Blood Pressure (BP) Values (mmHg)
Description
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Title
Change From Baseline in BP Values (mmHg)
Description
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary Outcome Measure Information:
Title
mTSS Score at Baseline, Months 12 and 24
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time Frame
Baseline, Months 12 and 24
Title
Change From Baseline in mTSS Score at Months 12 and 24
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame
Months 12 and 24
Title
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Time Frame
Months 6, 12, and 24
Title
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Description
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Time Frame
Months 6, 12, and 24
Title
Erosion Scores
Description
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Time Frame
Baseline, Months 6, 12, and 24
Title
JSN Scores
Description
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Time Frame
Baseline, Months 6, 12, and 24
Title
Change From Baseline in Erosion Scores
Description
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Months 6, 12, and 24
Title
Change From Baseline in JSN Scores
Description
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Months 6, 12, and 24
Title
Percentage of Participants Achieving an ACR70 Response
Description
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants Achieving an ACR20 Response
Description
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants Achieving an ACR50 Response
Description
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Tender Joints Count (TJC)
Description
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in TJC
Description
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Swollen Joints Count (SJC)
Description
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in SJC
Description
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Patient Assessment of Arthritis Pain
Description
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in Patient Assessment of Arthritis Pain
Description
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Physician Global Assessment of Arthritis
Description
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in Physician Global Assessment of Arthritis
Description
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Patient Global Assessment of Arthritis
Description
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in Patient Global Assessment of Arthritis
Description
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
C-Reactive Protein
Description
CRP measured in milligrams per liter (mg/L)
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in CRP
Description
Change from Baseline in CRP measured in mg/L.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in DAS28-3(CRP)
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in DAS28-4(ESR)
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-3(CRP) ≤3.2
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-4(ESR) ≤3.2
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-3(CRP) <2.6
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-4(ESR) <2.6
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
Description
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
Description
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
Description
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
Description
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame
Months 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
Description
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame
Months 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
Description
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame
Months 3, 6, 9, 12, 15, 18, 21, and 24
Title
Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in HAQ-DI Score
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires 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 sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Short Form 36 (SF-36) Mental Component Score
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
SF-36 Physical Component Score
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in SF-36 Mental Component Score
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in SF-36 Physical Component Score
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
SF-36 Domain Scores
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in SF-36 Domain Scores
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Work Limitation Questionnaire (WLQ) Score
Description
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time Frame
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in WLQ Scores
Description
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
WLQ Work Loss Index Score
Description
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
Time Frame
Baseline and Months 3, 6, and 12
Title
Change From Baseline in WLQ Work Loss Index Score
Description
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
Time Frame
Months 3, 6, 12, 15, 18, 21, and 24
Title
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
Description
EQ-5D: 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"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Baseline and Months 3, 6, 12, 18, and 24
Title
Change From Baseline in EQ-5D Health State Profile Utility Score
Description
EQ-5D: 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"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Months 3, 6, 12, 18, and 24
Title
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
Description
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time Frame
Baseline and Months 3 and 6
Title
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
Description
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time Frame
Months 12, 18, and 24
Title
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Description
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame
Baseline and Months 3 and 6
Title
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame
Months 12, 18, and 24
Title
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Description
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame
Baseline and Months 3 and 6
Title
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame
Months 12, 18, and 24
Title
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Description
RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time Frame
Baseline and Months 3 and 6
Title
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time Frame
Months 12, 18, and 24
Title
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Description
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame
Baseline, Months 3, 6, 12, 18, and 24
Title
Change From Baseline in Work Productivity and HCRU at Months 3 and 6
Description
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time Frame
Months 3 and 6
Title
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time Frame
Months 12, 18, and 24
Title
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6
Description
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame
Months 3 and 6
Title
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame
Months 12, 18, and 24
Title
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame
Months 3 and 6
Title
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame
Months 12, 18, and 24
Title
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time Frame
Months 3 and 6
Title
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
Description
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time Frame
Months 12, 18, and 24
Title
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Description
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame
Months 3, 6, 12, 18, and 24
Title
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
Description
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Time Frame
Baseline and Months 1, 2, and 3
Title
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Description
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
Time Frame
Months 1, 2, 3, 6, 12, 18, and 24
Title
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
Description
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Time Frame
Months 6, 12, 18, and 24
Title
Change From Baseline in MOS-SS at Months 1, 2, and 3
Description
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Time Frame
Months 1, 2, and 3
Title
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
Description
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Time Frame
Months 6, 12, 18, and 24
Title
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Description
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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). A higher score reflected an improvement in the participant's health status
Time Frame
Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Title
Change From Baseline in FACIT-Fatigue Scale
Description
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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). A higher score reflected an improvement in the participant's health status
Time Frame
Months 1, 2, 3, 6, 12, 18, and 24
Title
Change From Baseline in Heart Rate
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Title
Change From Baseline in Temperature
Time Frame
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
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
Catalina Pointe Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California San Diego Perlman Ambulatory Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0943
Country
United States
Facility Name
University of California San Diego Center for Innovative Therapy
City
La Jolla
State/Province
California
ZIP/Postal Code
92093 0943
Country
United States
Facility Name
Keck Hospital of USC, Lower Level Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Southeastern Arthritis Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern Imaging and Diagnostics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern Integrated Medical, PL dba Florida Medical Research
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Bernard F. Germain, MD
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Burnette & Silverfield, MDS PLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Diagnostic Rheumatology and Research, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Medical Associates Clinic, PC
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52002
Country
United States
Facility Name
Louisiana State University Health Sciences
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
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
Clinical Research Center of Reading, LLP
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical University of South Carolina - Rheumatology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina Investigational Drug Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Arthritis Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Austin Rheumatology Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Investigational Drug Service
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Mountain State Clinical Research
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
United Hospital Center (Imaging Only)
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
OMI - Organización Médica de Investigación
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Saint Dennis Medical Group S.A.
City
Buenos Aires
ZIP/Postal Code
C1034ACO
Country
Argentina
Facility Name
Consultorios Reumatológicos Pampa
City
Buenos Aires
ZIP/Postal Code
C1428DZF
Country
Argentina
Facility Name
Rheumatology Research Unit Sunshine Coast
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
The Queen Elizabeth Hospital, Department of Rheumatology
City
Woodville
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
Universitair Ziekenhuis Gent - Reumatologie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CIP - Centro Internacional de Pesquisas
City
Goiania
State/Province
GO
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
City
Goiania
State/Province
GO
ZIP/Postal Code
74115-030
Country
Brazil
Facility Name
Centro de Estudos em Terapias Inovadoras
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-240
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Revmatologichno Otdelenie, MBAL - Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Rheumatology Research Associates Ltd.
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Burlington Rheumatology and Osteoporosis Clinic
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7L 0B7
Country
Canada
Facility Name
Dr. William G. Bensen Medicine Professional Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Office of Dr. Fernando Bianchi
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
MAC Research Inc.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
KW Musculoskeletal Research Inc.
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
Rheumatology Research Associates
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Niagara Peninsula Arthritis Centre
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7E4
Country
Canada
Facility Name
Windsor Radiological Associates
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1K7
Country
Canada
Facility Name
Clinical Research and Arthritis Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Consulta Privada Dra. Lucia Ponce
City
Temuco
State/Province
IX Region
ZIP/Postal Code
4790928
Country
Chile
Facility Name
Centro de Estudios Reumatologicos
City
Santiago
State/Province
RM
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Consulta Privada Dra. Marta Aliste
City
Santiago
State/Province
RM
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Estudios Clinicos V Region
City
Vina del Mar
State/Province
V Region
ZIP/Postal Code
2570017
Country
Chile
Facility Name
Hospital Regional de Rancagua
City
Rancagua
ZIP/Postal Code
2841959
Country
Chile
Facility Name
Centro de Reumatologia y Ortopedia
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Centro Integral de Reumatologia e Inmunologia CIREI
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Servimed E.U
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Centro de Reumatología y Osteoporosis, Cartago
City
Cartago
ZIP/Postal Code
00000
Country
Costa Rica
Facility Name
Hospital Cima San Jose
City
San Jose
ZIP/Postal Code
00000
Country
Costa Rica
Facility Name
Revmacentrum MUDr. Mostera, s.r.o.
City
Brno - Zidenice
ZIP/Postal Code
61500
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Ostrava-Poruba
ZIP/Postal Code
70800
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Patricia Alvarez Site
City
Santo Domingo
ZIP/Postal Code
00000
Country
Dominican Republic
Facility Name
Privat-Praxis, Rheumatologie (P515)
City
Aachen
ZIP/Postal Code
52064
Country
Germany
Facility Name
Schlosspark-Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Schwerpunktpraxis Rheumatologie FAE Innere Medizin
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Arztpraxis, Internist - Rheumatologie
City
Nuernberg
ZIP/Postal Code
90429
Country
Germany
Facility Name
Rheumaforschung - Studienambulanz Dr. Wassenberg
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Schwerpunktpraxis fuer Rheumatologie
City
Rheine
ZIP/Postal Code
48431
Country
Germany
Facility Name
Drug Research Center Kft. Reumatologiai Szakrendeles
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Facility Name
Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
City
Mezokovesd
ZIP/Postal Code
3400
Country
Hungary
Facility Name
MAV Korhaz es Rendelointezet
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Mahavir Hospital & Research Center
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 004
Country
India
Facility Name
Department of Rheumatology
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Rheumatic Disease Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Shirdi Sai Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Arthritis Research and Care Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Shalby Hospital
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
Seoul National University Hospital, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hospital Tuanku Ja'afar
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Sunway Medical Centre
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Instituto Jaliscience de Investigación Clínica SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44158
Country
Mexico
Facility Name
Unidad de Investigacion en Enfermedades Cronico Degenerativas
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Hospital Universitario Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
City
Otahuhu
State/Province
Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
City
Christchurch
ZIP/Postal Code
8022
Country
New Zealand
Facility Name
Ryburns Building, Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Timaru Hospital, Clinical Trials Unit
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Hospital Nacional IV Alberto Sabogal Sologuren
City
Callao
ZIP/Postal Code
C-02
Country
Peru
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
L 27
Country
Peru
Facility Name
Centro Medico Corpac
City
Lima
ZIP/Postal Code
L-27
Country
Peru
Facility Name
Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
City
Lima
ZIP/Postal Code
L-27
Country
Peru
Facility Name
Chong Hua Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
City
Gdynia
ZIP/Postal Code
81-367
Country
Poland
Facility Name
Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Synexus SCM Sp. z o.o. Oddzial Warszawa
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Ponce School of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Edificio Parra
City
Ponce
ZIP/Postal Code
00717-1321
Country
Puerto Rico
Facility Name
State Healthcare Institution Regional Clinical Hospital
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
State Healthcare Institution
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education
City
Ekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
State Healthcare Institution Regional Clinical Hospital for War Veterans
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Almazov Federal Heart, Blood and Endocrinology Centre
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
City
St. Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Reumatolog s.r.o.
City
Bratislava
ZIP/Postal Code
81108
Country
Slovakia
Facility Name
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
City
Dunajska Streda
ZIP/Postal Code
92901
Country
Slovakia
Facility Name
Reumatologicka ambulancia, Ecclesia, s.r.o.
City
Nove Zamky
ZIP/Postal Code
94001
Country
Slovakia
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
Nestatna reumatologicka ambulancia
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Hospital Nuestra Señora de La Esperanza
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Civil. Hospital Regional Universitario Carlos Haya
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Skanes Universitetssjukhus i Malmo
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Sundsvalls sjukhus- Medicinkliniken
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Akademiska sjukhuset, Reumatologmottagningen
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
City
Phayathai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
City
Simferopol
State/Province
Crimea
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Municipal City Clinical Hospital #4, Department of Rheumatology
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
35577477
Citation
Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
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
34057820
Citation
Bykerk VP, Lee EB, van Vollenhoven R, Gruben DC, Fallon L, Woolcott JC, Keystone E. Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months. Arthritis Care Res (Hoboken). 2022 Jan;74(1):131-141. doi: 10.1002/acr.24709.
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
33059710
Citation
Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
Results Reference
derived
PubMed Identifier
33057725
Citation
van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
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
30177460
Citation
Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
Results Reference
derived
PubMed Identifier
29761420
Citation
Strand V, Kavanaugh A, Kivitz AJ, van der Heijde D, Kwok K, Akylbekova E, Soonasra A, Snyder M, Connell C, Bananis E, Smolen JS. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7. Epub 2018 May 14.
Results Reference
derived
PubMed Identifier
29696833
Citation
van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
Results Reference
derived
PubMed Identifier
28143815
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Results Reference
derived
PubMed Identifier
27493790
Citation
Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
Results Reference
derived
PubMed Identifier
27175296
Citation
Fleischmann R, Strand V, Wilkinson B, Kwok K, Bananis E. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naive patients with rheumatoid arthritis. RMD Open. 2016 Apr 26;2(1):e000232. doi: 10.1136/rmdopen-2015-000232. eCollection 2016.
Results Reference
derived
PubMed Identifier
25047021
Citation
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Results Reference
derived
PubMed Identifier
24941177
Citation
Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-86. doi: 10.1056/NEJMoa1310476.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921069&StudyName=Comparing%20The%20Effectiveness%20And%20Safety%20Of%202%20Doses%20Of%20An%20Experimental%20Drug%2C%20CP-690%2C550%2C%20To%20Methotrexate%20%28MTX%29%20In%20Patients%20With%20
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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
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