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
ORAL1069
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
2 other identifiers
interventional
956
29 countries
173
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2010
Typical duration for phase_3
173 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2009
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
April 6, 2018
CompletedApril 6, 2018
March 1, 2018
3.2 years
December 23, 2009
March 10, 2014
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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).
Month 6
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.
Month 6
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).
Month 6
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.
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
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.
Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary Outcomes (83)
mTSS Score at Baseline, Months 12 and 24
Baseline, Months 12 and 24
Change From Baseline in mTSS Score at Months 12 and 24
Months 12 and 24
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
Months 6, 12, and 24
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Months 6, 12, and 24
Erosion Scores
Baseline, Months 6, 12, and 24
- +78 more secondary outcomes
Study Arms (3)
5 mg BID CP-690,550
EXPERIMENTAL10 mg BID CP-690,550
EXPERIMENTALmethotrexate
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (176)
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205, United States
University of California San Diego Perlman Ambulatory Clinic
La Jolla, California, 92037-0943, United States
University of California San Diego Center for Innovative Therapy
La Jolla, California, 92093 0943, United States
Keck Hospital of USC, Lower Level Pharmacy
Los Angeles, California, 90033, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Southeastern Arthritis Center
Gainesville, Florida, 32607, United States
Southeastern Imaging and Diagnostics
Gainesville, Florida, 32607, United States
Southeastern Integrated Medical, PL dba Florida Medical Research
Gainesville, Florida, 32607, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, 33173, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321, United States
Bernard F. Germain, MD
Tampa, Florida, 33613, United States
Burnette & Silverfield, MDS PLC
Tampa, Florida, 33614, United States
Diagnostic Rheumatology and Research, PC
Indianapolis, Indiana, 46227, United States
Medical Associates Clinic, PC
Dubuque, Iowa, 52002, United States
Louisiana State University Health Sciences
New Orleans, Louisiana, 70115, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
The Center for Rheumatology
Albany, New York, 12206, United States
AAIR Research Center
Rochester, New York, 14618, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Medical University of South Carolina - Rheumatology
Charleston, South Carolina, 29425, United States
Medical University of South Carolina Investigational Drug Services
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Arthritis Clinic
Jackson, Tennessee, 38305, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Austin Rheumatology Research
Austin, Texas, 78705, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107, United States
Investigational Drug Service
Seattle, Washington, 98101, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
United Hospital Center (Imaging Only)
Clarksburg, West Virginia, 26301, United States
OMI - OrganizaciĂ³n MĂ©dica de InvestigaciĂ³n
Buenos Aires, C1015ABO, Argentina
Saint Dennis Medical Group S.A.
Buenos Aires, C1034ACO, Argentina
Consultorios ReumatolĂ³gicos Pampa
Buenos Aires, C1428DZF, Argentina
Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, 4558, Australia
The Queen Elizabeth Hospital, Department of Rheumatology
Woodville, South Australia, 5011, Australia
Emeritus Research
Malvern East, Victoria, 3145, Australia
Universitair Ziekenhuis Gent - Reumatologie
Ghent, 9000, Belgium
CIP - Centro Internacional de Pesquisas
GoiĂ¢nia, GoiĂ¡s, 74110-120, Brazil
Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
GoiĂ¢nia, GoiĂ¡s, 74115-030, Brazil
Centro de Estudos em Terapias Inovadoras
Curitiba, ParanĂ¡, 80060-240, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
SĂ£o Paulo, SĂ£o Paulo, 04266-010, Brazil
CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
Rio de Janeiro, 22271-100, Brazil
Revmatologichno Otdelenie, MBAL - Plovdiv
Plovdiv, 4000, Bulgaria
MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
Rousse, 7002, Bulgaria
MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
Sofia, 1606, Bulgaria
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
Sofia, 1612, Bulgaria
DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
Sofia, 1709, Bulgaria
MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
Veliko Tarnovo, 5000, Bulgaria
Rheumatology Research Associates Ltd.
Edmonton, Alberta, T5M 0H4, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3P9, Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
Burlington Rheumatology and Osteoporosis Clinic
Burlington, Ontario, L7L 0B7, Canada
Dr. William G. Bensen Medicine Professional Corporation
Hamilton, Ontario, L8N 1Y2, Canada
Office of Dr. Fernando Bianchi
Hamilton, Ontario, L8N 1Y2, Canada
MAC Research Inc.
Hamilton, Ontario, L8N 2B6, Canada
KW Musculoskeletal Research Inc.
Kitchener, Ontario, N2M 5N6, Canada
Rheumatology Research Associates
Ottawa, Ontario, K1H 1A2, Canada
Niagara Peninsula Arthritis Centre
St. Catharines, Ontario, L2N 7E4, Canada
Windsor Radiological Associates
Windsor, Ontario, N8X 1K7, Canada
Clinical Research and Arthritis Centre
Windsor, Ontario, N8X 5A6, Canada
Consulta Privada Dra. Lucia Ponce
Temuco, RegiĂ³n de la AraucanĂa, 4790928, Chile
Estudios Clinicos V Region
Viña del Mar, RegiĂ³n de ValparaĂso, 2570017, Chile
Centro de Estudios Reumatologicos
Santiago, RM, 7501126, Chile
Consulta Privada Dra. Marta Aliste
Santiago, RM, 7510186, Chile
Hospital Regional de Rancagua
Rancagua, 2841959, Chile
Centro de Reumatologia y Ortopedia
Barranquilla, AtlĂ¡ntico, Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota, Cundinamarca, 0000, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Centro de ReumatologĂa y Osteoporosis, Cartago
Cartago, 00000, Costa Rica
Hospital Cima San Jose
San José, 00000, Costa Rica
Fakultni nemocnice Brno
Brno, 62500, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno-Židenice, 61500, Czechia
Fakultni nemocnice Hradec Kralove
Hradec KrĂ¡lovĂ©, 50005, Czechia
Revmatologicka ambulance
Ostrava-Poruba, 70800, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Revmatologicka ambulance
Prague, 140 00, Czechia
Patricia Alvarez Site
Santo Domingo, 00000, Dominican Republic
Privat-Praxis, Rheumatologie (P515)
Aachen, 52064, Germany
Schlosspark-Klinik
Berlin, 14059, Germany
Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Schwerpunktpraxis Rheumatologie FAE Innere Medizin
Halle, 06108, Germany
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
Hamburg, 22081, Germany
Arztpraxis, Internist - Rheumatologie
Nuremberg, 90429, Germany
Rheumaforschung - Studienambulanz Dr. Wassenberg
Ratingen, 40882, Germany
Schwerpunktpraxis fuer Rheumatologie
Rheine, 48431, Germany
Drug Research Center Kft. Reumatologiai Szakrendeles
BalatonfĂ¼red, 8230, Hungary
Revita Reumatologiai Rendelo
Budapest, 1027, Hungary
Synexus Magyarorszag Kft.
Budapest, H-1036, Hungary
Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
MezÅ‘kövesd, 3400, Hungary
MAV Korhaz es Rendelointezet
Szolnok, H-5000, Hungary
Mahavir Hospital & Research Center
Hyderabad, Andhra Pradesh, 500 004, India
Department of Rheumatology
Secunderabad, Andhra Pradesh, 500003, India
Rheumatic Disease Clinic
Ahmedabad, Gujarat, 380009, India
Shirdi Sai Hospital
Bangalore, Karnataka, 560 054, India
Arthritis Research and Care Foundation
Pune, Maharashtra, 411 001, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411 001, India
Shalby Hospital
Ahmedabad, 380015, India
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, 70300, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, 46150, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
TorreĂ³n, Coahuila, 27000, Mexico
Instituto Jaliscience de InvestigaciĂ³n ClĂnica SA de CV
Guadalajara, Jalisco, 44158, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas
Guadalajara, Jalisco, 44620, Mexico
Hospital Universitario Jose Eleuterio Gonzalez
Monterrey, Nuevo LeĂ³n, 64020, Mexico
Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
Otahuhu, Auckland, 1640, New Zealand
The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
Christchurch, 8022, New Zealand
Ryburns Building, Waikato Hospital
Hamilton, 3204, New Zealand
Timaru Hospital, Clinical Trials Unit
Timaru, 7910, New Zealand
Hospital Nacional IV Alberto Sabogal Sologuren
Callao, C-02, Peru
Clinica Anglo Americana
Lima, L 27, Peru
Centro Medico Corpac
Lima, L-27, Peru
Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
Lima, L-27, Peru
Chong Hua Hospital
Cebu City, 6000, Philippines
Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
Davao City, 8000, Philippines
Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
Manila, 1003, Philippines
Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
Gdynia, 81-367, Poland
Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
Gdynia, 81-384, Poland
Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
Katowice, 40-748, Poland
Synexus SCM Sp. z o.o. Oddzial Warszawa
Warsaw, 01-192, Poland
Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
Warsaw, 02-118, Poland
Ponce School of Medicine
Ponce, 00716, Puerto Rico
Edificio Parra
Ponce, 00717-1321, Puerto Rico
State Healthcare Institution Regional Clinical Hospital
Barnaul, 656024, Russia
State Healthcare Institution Regional Clinical Hospital for War Veterans
Kemerovo, 650099, Russia
Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
Novosibirsk, 630055, Russia
Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
Novosibirsk, 630117, Russia
State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
Saint Petersburg, 190068, Russia
Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
Saint Petersburg, 194291, Russia
Almazov Federal Heart, Blood and Endocrinology Centre
Saint Petersburg, 197341, Russia
State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
Saint Petersburg, 197706, Russia
St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
Saint Petersburg, 198260, Russia
Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
Smolensk, 214019, Russia
Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
State Healthcare Institution
Yekaterinburg, 620102, Russia
Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
Yekaterinburg, 620109, Russia
State Educational Institution of Higher Professional Education
Yekaterinburg, 620149, Russia
Reumatolog s.r.o.
Bratislava, 81108, Slovakia
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
DunajskĂ¡ Streda, 92901, Slovakia
Reumatologicka ambulancia, Ecclesia, s.r.o.
NovĂ© ZĂ¡mky, 94001, Slovakia
Narodny ustav reumatickych chorob
Piešťany, 921 12, Slovakia
Nestatna reumatologicka ambulancia
Žilina, 010 01, Slovakia
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, 110-744, South Korea
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Seoul, 120-752, South Korea
Asan Medical Center, Rheumatology, Internal Medicine
Seoul, 138-736, South Korea
Hospital Nuestra Señora de La Esperanza
Santiago de Compostela, A Coruña, 15705, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Civil. Hospital Regional Universitario Carlos Haya
MĂ¡laga, 29009, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Skanes Universitetssjukhus i Malmo
Malmo, 205 02, Sweden
Sundsvalls sjukhus- Medicinkliniken
Sundsvall, 851 86, Sweden
Akademiska sjukhuset, Reumatologmottagningen
Uppsala, 751 85, Sweden
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Phayathai, Bangkok, 10400, Thailand
Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
Simferopol, Autonomous Republic of Crimea, 95017, Ukraine
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
Kyiv, 04053, Ukraine
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
Kyiv, 04114, Ukraine
Municipal City Clinical Hospital #4, Department of Rheumatology
Lviv, 79011, Ukraine
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
Odesa, 65026, Ukraine
Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
Vinnitsa, 21018, Ukraine
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PMID: 33059710DERIVEDvan 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.
PMID: 33057725DERIVEDPanaccione 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.
PMID: 32816215DERIVEDKivitz 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.
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PMID: 24941177DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2009
First Posted
December 25, 2009
Study Start
January 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 6, 2018
Results First Posted
April 6, 2018
Record last verified: 2018-03