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A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA-BRIDGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915964
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: TNF Inhibitor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baricitinib Low Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Experimental: Baricitinib High Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Active Comparator: TNF Inhibitor
Adalimumab or etanercept administered subcutaneously (SC) per standard of care.
Drug: TNF Inhibitor
Administered SC
Other Names:
  • Etanercept
  • Adalimumab




Primary Outcome Measures :
  1. Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First Event of VTE


Secondary Outcome Measures :
  1. Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First ATE

  2. Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First MACE

  3. Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC]) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)

  4. Time from First Dose of Study Treatment to First Opportunistic Infection [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First Opportunistic Infection

  5. Time from First Dose of Study Treatment to First Serious Infection [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]
    Time from First Dose of Study Treatment to First Serious Infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have at least one of the following characteristics:

    • Documented evidence of a VTE prior to this study
    • At least 60 years of age
    • A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
    • Age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
  • Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).

Exclusion Criteria:

  • Participant should have no reason to not take a TNF inhibitor.
  • Participants must not be pregnant or breastfeeding.
  • Participants must not have had more than one VTE.
  • Participants must not have cancer.
  • Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
  • Participants must not have had a live vaccine within four weeks of study start.
  • Participants must not have participated in any other clinical trial within four weeks of study start.
  • Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915964


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Hide Hide 314 study locations
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United States, Arizona
Arizona Arthritis & Rheumatology Research Recruiting
Flagstaff, Arizona, United States, 86001
Contact    602-926-9753      
Principal Investigator: Alexander Hu         
ArthroCare, Arthritis Care & Research Recruiting
Gilbert, Arizona, United States, 85234
Contact    480-834-6576      
Principal Investigator: Michael Fairfax         
Arizona Arthritis & Rheumatology Research Recruiting
Glendale, Arizona, United States, 85306
Contact    602-386-4970      
Principal Investigator: Mona Amin         
Arizona Arthritis & Rheumatology Associates, P. C. Recruiting
Mesa, Arizona, United States, 85210
Contact    480-321-8558      
Principal Investigator: Swati S Bharadwaj         
The Pain Center of Arizona Recruiting
Peoria, Arizona, United States, 85018
Contact    602-288-4673      
Principal Investigator: Matthew Doust         
The Pain Center of Arizona Recruiting
Peoria, Arizona, United States, 85381
Contact    602-288-4673      
Principal Investigator: Abram Burgher         
Arizona Arthritis & Rheumatology Research, PLLC Recruiting
Tucson, Arizona, United States, 85704
Contact    520-332-2952      
Principal Investigator: Jeffrey B Loomer         
United States, California
Medvin Clinical Research Recruiting
Covina, California, United States, 91722
Contact    626-869-5730      
Principal Investigator: Samy K Metyas         
St. Joseph Heritage Medical Group Recruiting
Fullerton, California, United States, 92835
Contact    714-833-4831      
Principal Investigator: Shirley W Pang         
Newport Huntington Medical Group Recruiting
Huntington Beach, California, United States, 92648
Contact    714-378-2440      
Principal Investigator: Christine Thai         
Dr. Christine J. Leehealey, MD Recruiting
Irvine, California, United States, 92604
Contact    949-654-3763      
Principal Investigator: Christine J Leehealey         
Desert Medical Advances Recruiting
Palm Desert, California, United States, 92260
Contact    760-341-9638      
Principal Investigator: Maria Greenwald         
Rheumatology Center of San Diego Recruiting
San Diego, California, United States, 92128
Contact    858-869-1285      
Principal Investigator: Tania Rivera         
East Bay Rheumatology Medical Group Recruiting
San Leandro, California, United States, 94578
Contact    510-357-1303      
Principal Investigator: Suneet Grewal         
Dan La, MD Inc. Recruiting
Tujunga, California, United States, 91042
Contact    8182652250      
Principal Investigator: Dan Tan La         
Robin K. Dore MD, Inc. Recruiting
Tustin, California, United States, 92780
Contact    714-505-5000      
Principal Investigator: Roger Kornu         
Inland Rheumatology Clinical Trials Recruiting
Upland, California, United States, 91786
Contact    909-296-8700      
Principal Investigator: Antony Hou         
Medvin Clinical Research Recruiting
Van Nuys, California, United States, 91405
Contact    818-286-3989      
Principal Investigator: Charles E Weidmann         
Medvin Clinical Research Recruiting
Whittier, California, United States, 90602
Contact    818-516-5390      
Principal Investigator: Tien-I Su         
United States, Connecticut
Clinical Research Center of CT/NY Recruiting
Danbury, Connecticut, United States, 06810
Contact    203-616-2710      
Principal Investigator: Richard Roseff         
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 06905
Contact    203-325-8529      
Principal Investigator: Stuart Novack         
United States, Florida
Rheumatology Associates of South Florida Recruiting
Boca Raton, Florida, United States, 33486
Contact    561-361-6547      
Principal Investigator: Joseph Z Forstot         
Suncoast Research Group, LLC Recruiting
Miami, Florida, United States, 33135
Contact    305-631-6704      
Principal Investigator: Ricardo Garcia-Alemany         
New Horizon Research Center Recruiting
Miami, Florida, United States, 33165
Contact    305-226-3933      
Principal Investigator: Richard Fernandez         
Jeffrey Alper MD Research Recruiting
Naples, Florida, United States, 34102
Contact    239-248-5503      
Principal Investigator: Jeffrey A Alper         
Sun Coast Clinical Research, Inc Recruiting
New Port Richey, Florida, United States, 34652
Contact    727-849-4131      
Principal Investigator: Farrukh Zaidi         
IRIS Research and Development, LLC Recruiting
Plantation, Florida, United States, 33324
Contact    954-476-2338      
Principal Investigator: Guillermo Valenzuela         
Qps-Mra, Llc Recruiting
South Miami, Florida, United States, 33143
Contact    305-598-3125      
Principal Investigator: Jaime A Pachon         
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
Contact    813-264-2155      
Principal Investigator: Priya Ramani         
United States, Georgia
Arthritis and Rheumatology of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact    404-255-5956      
Principal Investigator: Gary E. Myerson         
Arthritis Center of North Georgia Recruiting
Gainesville, Georgia, United States, 30501
Contact    770-531-3711      
Principal Investigator: Marta Bognar         
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics Recruiting
Boise, Idaho, United States, 83702
Contact    208-489-4262      
Principal Investigator: James E. Loveless         
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact    773-275-3500      
Principal Investigator: Manish Jain         
United States, Indiana
Qualmedica Research LLC Recruiting
Evansville, Indiana, United States, 47714
Contact    812-604-0088      
Principal Investigator: Moges Sisay         
The Indiana Clinical Trials Center, PC Recruiting
Plainfield, Indiana, United States, 46168
Contact    317-837-6082      
Principal Investigator: Scott T Guenthner         
United States, Kansas
Cotton O'Neil Clinic Recruiting
Topeka, Kansas, United States, 66606
Contact    785-354-9591      
Principal Investigator: Scott M Teeter         
Professional Research Network of Kansas Recruiting
Wichita, Kansas, United States, 67205
Contact    316-838-7700      
Principal Investigator: Basit Malik         
United States, Kentucky
Center for Arthritis & Osteoporosis Recruiting
Elizabethtown, Kentucky, United States, 42701
Contact    270-769-2535      
Principal Investigator: Daksha Mehta         
United States, Louisiana
Accurate Clinical Research Recruiting
Lake Charles, Louisiana, United States, 70601
Contact    337-312-8619      
Principal Investigator: Enrique A. Mendez         
United States, Maryland
The Center for Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
Contact    301-942-6610      
Principal Investigator: Paul J DeMarco         
United States, Massachusetts
NECCR PrimaCare Research, LLC Recruiting
Fall River, Massachusetts, United States, 02721
Contact    508-646-7615      
Principal Investigator: Mark Fisher         
Reliant Medical Group, Inc. Recruiting
Worcester, Massachusetts, United States, 01606
Contact    508-595-2213      
Principal Investigator: Elinor Mody         
United States, Michigan
University of Michigan Recruiting
Brighton, Michigan, United States, 48116
Contact    5173211525      
Principal Investigator: Patricia Claudia Cagnoli         
West Michigan Rheumatology Recruiting
Grand Rapids, Michigan, United States, 49546
Contact    616-459-8088      
Principal Investigator: Andrew J Head         
Advanced Rheumatology Recruiting
Lansing, Michigan, United States, 48910
Contact    517-908-3600      
Principal Investigator: Monika Mohan         
Beals Institute PC Recruiting
Lansing, Michigan, United States, 48917
Contact    517-321-1525      
Principal Investigator: Carol Beals         
United States, Missouri
StudyMetrix Research, LLC Recruiting
Saint Peters, Missouri, United States, 63303
Contact    636-387-5100      
Principal Investigator: Timothy R Smith         
Clinvest Research LLC Recruiting
Springfield, Missouri, United States, 65810
Contact    417-883-7889      
Principal Investigator: David G. True         
United States, Montana
Glacier View Research Institute Recruiting
Kalispell, Montana, United States, 59901
Contact    406-755-1460      
Principal Investigator: Roger Diegel         
United States, Nebraska
Physician Research Collaboration, LLC Recruiting
Lincoln, Nebraska, United States, 68516
Contact    402-420-1212      
Principal Investigator: Melvin A Churchill         
Westroads Clinical Research-Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact    4029341666      
Principal Investigator: William Rodney Palmer         
United States, Nevada
Allied Clinical Research Recruiting
Reno, Nevada, United States, 89519
Contact    775-800-6999      
Principal Investigator: Bryan J Wolf         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0001
Contact    603-650-8162      
Principal Investigator: William F Rigby         
United States, New Jersey
Ocean Rheumatology Recruiting
Toms River, New Jersey, United States, 08755
Contact    732-505-2888      
Principal Investigator: Ramesh Kumar         
United States, New Mexico
Albuquerque Clinical Trials Recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-224-7407      
Principal Investigator: Marigene D Salazar Sharma         
Albuquerque Rehabilitation & Rheumatology, PC Recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-341-4148      
Principal Investigator: Leroy A Pacheco         
Santa Fe Rheumatology Recruiting
Santa Fe, New Mexico, United States, 87505
Contact    608-848-8900      
Principal Investigator: Hillary Norton         
United States, New York
Manhattan Medical Research Recruiting
New York, New York, United States, 10016
Contact    212-480-3333      
Principal Investigator: Mark Eberle         
United States, North Carolina
PMG Research of Charlotte, LLC Recruiting
Charlotte, North Carolina, United States, 28209
Contact    704-527-6672      
Principal Investigator: George Raad         
M3-Emerging Medical Research, LLC Recruiting
Durham, North Carolina, United States, 27704
Contact    919-281-1698      
Principal Investigator: Linda R Belhorn         
Piedmont Rheumatology Recruiting
Hickory, North Carolina, United States, 28602
Contact    828-345-5060      
Principal Investigator: Dayton Payne         
Cape Fear Arthritis Care Recruiting
Leland, North Carolina, United States, 28451
Contact    608-848-8900      
Principal Investigator: David H. Snow         
PMG Research of Salisbury Recruiting
Salisbury, North Carolina, United States, 28144
Contact    148-260-5298      
Principal Investigator: Rakesh C Patel         
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Contact    910-815-6108      
Principal Investigator: Ronald George         
United States, Ohio
Cincinnati Rheumatic Disease Study Group @ the Deaconess Art Recruiting
Cincinnati, Ohio, United States, 45242
Contact    513-559-2370      
Principal Investigator: Michael Luggen         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact    614-293-4837      
Principal Investigator: Sheryl Mascarenhas         
Marietta Memorial Hospital (OH091) Recruiting
Marietta, Ohio, United States, 45750
Contact    740-568-2214      
Principal Investigator: Jonathan Krant         
Paramount Medical Research Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact    440-826-0742      
Principal Investigator: Isam A. Diab         
United States, Oklahoma
Health Research Institute Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact    4057026770      
Principal Investigator: Christine Ellen Codding         
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104-5046
Contact    405-271-7805      
Principal Investigator: Cristina Arriens         
United States, Pennsylvania
East Penn Rheumatology Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact    610-868-1336      
Principal Investigator: Charles L. Ludivico         
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact    814-693-0300      
Principal Investigator: Alan J. Kivitz         
Clinical Research Center of Reading, LLC Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact    610-375-2466      
Principal Investigator: Robert M Griffin Jr.         
Pennsylvania Regional Center for Arthritis & Osteoarthritis Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact    610-374-8133      
Principal Investigator: Gregory R Emkey         
United States, South Dakota
Regional Health Clinical Research Recruiting
Rapid City, South Dakota, United States, 57701
Contact    605-755-4326      
Principal Investigator: Cynthia Weaver         
United States, Texas
Accurate Clinical Management LLC - BayTown Recruiting
Baytown, Texas, United States, 77521
Contact    281-481-8557      
Principal Investigator: Sabeen Najam         
Arthritis & Osteoporosis Clinic of Brazos Valley Recruiting
College Station, Texas, United States, 77845
Contact    979-696-8000      
Principal Investigator: Ricardo Pocurull         
Abigail Neiman, MD, PA Recruiting
Houston, Texas, United States, 77024
Contact    7139320054      
Principal Investigator: Abigail Rebecca Neiman         
Rheumatology Clinic of Houston, PA Recruiting
Houston, Texas, United States, 77065
Contact    281-517-0550      
Principal Investigator: Qaiser Rehman         
Accurate Clinical Management LLC - Katy Recruiting
Houston, Texas, United States, 77084
Contact    832-672-7973      
Principal Investigator: Amber Khan         
Accurate Clinical Research Recruiting
Houston, Texas, United States, 77089
Contact    281-481-8557      
Principal Investigator: Philip A Waller         
Laila A Hassan, MD, PA Recruiting
Houston, Texas, United States, 77089
Contact    832-847-1727      
Principal Investigator: Laila Hassan         
Accurate Clinical Research Recruiting
League City, Texas, United States, 77573
Contact    713-677-0086      
Principal Investigator: Prashanth R Sunkureddi         
Accurate Clinical Research - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact    210-762-6579      
Principal Investigator: Alex De Jesus         
Arthritis Associates, PA Recruiting
San Antonio, Texas, United States, 78229
Contact    2106271606      
Principal Investigator: Pendleton Brewster Wickersham         
Accurate Clinical Management Recruiting
Sugar Land, Texas, United States, 77479
Contact    2819801742      
Principal Investigator: Jesus Edward Hernandez         
DM Clinical Research Recruiting
Tomball, Texas, United States, 77375
Contact    281-517-0550      
Principal Investigator: Shaikh Arif Ali         
United States, Washington
Arthritis Northwest PLLC Recruiting
Spokane, Washington, United States, 99204
Contact    509-838-6500      
Principal Investigator: Eric C Mueller         
Vancouver Clinic Recruiting
Vancouver, Washington, United States, 98664
Contact    360-397-3388      
Principal Investigator: Theresa Karplus         
United States, West Virginia
West Virginia Research Institute Recruiting
South Charleston, West Virginia, United States, 25309
Contact    3043894455      
Principal Investigator: Suzanne Lee Gharib         
Australia, New South Wales
Optimus Clinical Research Recruiting
Kogarah, New South Wales, Australia, 2217
Contact    61289648186      
Principal Investigator: Paul Bird         
Genesis Research Services Recruiting
Newcastle, New South Wales, Australia, 2292
Contact    412675026      
Principal Investigator: John Dominic Van der Kallen         
Australia, Queensland
Coast Joint Care Recruiting
Maroochydore, Queensland, Australia, 4558
Contact    61754431033      
Principal Investigator: Peter Nash         
Australia, Tasmania
Southern Clinical Research Pty Ltd Recruiting
Hobart, Tasmania, Australia, 7000
Contact    61362238802      
Principal Investigator: Deborah Speden         
Australia, Victoria
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Contact    61395096166      
Principal Investigator: Andrew Ostor         
Austria
Klinikum Wels-Grieskirchen GmbH, Standort Wels Recruiting
Wels, Oberösterreich, Austria, 4600
Contact    4372424153321      
Principal Investigator: Harald Hofer         
AKH Recruiting
Wien, Austria, 1090
Contact    431404000      
Principal Investigator: Klaus Machold         
Rheuma-Zentrum Wien Oberlaa Recruiting
Wien, Austria, 1100
Contact    4301680099226      
Principal Investigator: Peter Spellitz         
KH Hietzing mit neurologischem Zentrum Rosenhügel Recruiting
Wien, Austria, 1130
Contact    436648445421      
Principal Investigator: Jutta Stieger         
Wilhelminenspital Recruiting
Wien, Austria, 1160
Contact    431491502401      
Principal Investigator: Peter Fasching         
Belgium
Hôpital Saint Joseph (Grand hôpital de Charleroi) Recruiting
Charleroi, Hainaut, Belgium, 6060
Contact    0032475420863      
Principal Investigator: Marc Vanden Berghe         
Jan Palfijn Ziekenhuis Recruiting
Merksem, Vlaams Gewest, Belgium, 2170
Contact    3236402851      
Principal Investigator: Rik Joos         
Hospital Universitaire Erasme Brussel Recruiting
Brussel, Belgium, 1070
Contact    3225555377      
Principal Investigator: Joëlle Margaux         
Reumaclinic Recruiting
Genk, Belgium, 3600
Contact    3289362977      
Principal Investigator: JOHAN VANHOOF         
Centre Hospitalier Universitaire Sart Tilman Recruiting
Liege, Belgium, 4000
Contact    003243667229      
Principal Investigator: Michel Malaise         
Czechia
Nuselska poliklinika Recruiting
Praha 4, Czech Republic, Czechia, 140 00
Contact    420234091145      
Principal Investigator: Zuzana Stejfova         
Clintrial, s.r.o. Recruiting
Praha 10, Hl. M. Praha, Czechia, 100 00
Contact    420608052214      
Principal Investigator: Vlasta Gollerova         
MEDICAL PLUS, s.r.o. Recruiting
Uherske Hradiste, Zlínský Kraj, Czechia, 686 01
Contact    420572551850      
Principal Investigator: Eva Dokoupilova         
Revmacentrum MUDr. Mostera s.r.o. Recruiting
Brno - Zidonice, Czechia, 615 00
Contact    420608439550      
Principal Investigator: Erik Moster         
Revmaclinic, s.r.o Recruiting
Brno, Czechia, 611 41
Contact    420541552301      
Principal Investigator: Vlastimil Racek         
Poliklinika Lesna Recruiting
Brno, Czechia, 638 00
Contact    420545214556      
Principal Investigator: Leona Prochazkova         
Artroscan s.r.o Recruiting
Ostrava - Trebovice, Czechia, 722 00
Contact    420596938950      
Principal Investigator: Ladislav Bortlik         
Interni a revmatologicka ambulance, Inrea s.r.o. Recruiting
Ostrava, Czechia, 703 00
Contact    420595957373      
Principal Investigator: Martina Malcova         
Arthrohelp s.r.o Recruiting
Pardubice, Czechia, 530 02
Contact    420464007686      
Principal Investigator: Zdenek Dvorak         
Affidea Praha, s.r.o. Recruiting
Praha 11, Czechia, 148 00
Contact    420267090872      
Principal Investigator: Jan Rosa         
Revmatologicky ustav Recruiting
Praha 2, Czechia, 128 50
Contact    420234075338      
Principal Investigator: Radka Moravcova         
Thomayerova Nemocnice Recruiting
Praha 4 - Krc, Czechia, 140 59
Contact    420261082108      
Principal Investigator: Petr Kopsa         
Revmatologicka ambulance Recruiting
Praha 4 Nusle, Czechia, 140 00
Contact    420261225638      
Principal Investigator: Zuzana Urbanova         
PV-MEDICAL s.r.o. Revmatologicka ambulance Recruiting
Zlin, Czechia, 760 01
Contact    420577221686      
Principal Investigator: Petr Vitek         
Denmark
Odense Universitetshospital Not yet recruiting
Odense C, Syd, Denmark, 5000
Contact    4566113333      
Principal Investigator: Hanne Lindegaard         
Aalborg Universitetshospital - Psykiatrien Not yet recruiting
Aalborg, Denmark, 9000
Contact    4597664054      
Principal Investigator: Annette Schlemmer         
Silkeborg Centralsygehus, Medicinsk Afdeling Not yet recruiting
Silkeborg, Denmark, 8600
Contact    4587222355      
Principal Investigator: Rene Drage Oestgaard         
Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital Recruiting
Svendborg, Denmark, 5700
Contact    26714567      
Principal Investigator: Soren Just         
France
Chu de Nice Hopital Pasteur Recruiting
Nice, Alpes-Maritimes, France, 06000
Contact    0033492039220      
Principal Investigator: Christian Roux         
Bordeaux University Hospital- Pellegrin Recruiting
Bordeaux, Aquitaine, France, 33076
Contact    0556794919      
Principal Investigator: Christophe RICHEZ         
Hôpital de HautePierre Recruiting
Strasbourg, Bas-Rhin, France, 67098
Contact    0388127953      
Principal Investigator: Jacques-Eric Gottenberg         
CHRU de Lille - Hôpital Roger Salengro Recruiting
Lille, Cedex, France, 59037
Contact    0033320446926      
Principal Investigator: Rene Flipo         
Hôpital Pierre-Paul Riquet Recruiting
Toulouse, Haute-Garonne, France, 31059
Contact    33561776966      
Principal Investigator: Arnaud Constantin         
CHRU de Limoges Hopital Dupuytren Recruiting
Limoges, Haute-Vienne, France, 87042
Contact    33555056870      
Principal Investigator: Pascale Vergne-Salle         
Centre Hospitalier de Vendee Les Oudairies Recruiting
Vendée, La Roche-sur-Yon, France, 85000
Contact    33251446052      
Principal Investigator: Gregoire Cormier         
Chru De Nantes Hotel-Dieu Recruiting
Nantes, Loire-Atlantique, France, 44093
Contact    33240084825      
Principal Investigator: Yves Maugars         
CHU Brabois Recruiting
Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54511
Contact    + 33 382 15 32 03      
Principal Investigator: Isabelle Chary-Valckenaere         
Centre Hospitalier Regional D'Orleans Recruiting
Loiret, Orléans, France, 45067
Contact    33238629922      
Principal Investigator: Carine Salliot         
Hopital Gabriel Montpied Recruiting
Clermont-Ferrand, Puy-de-Dôme, France, 63000
Contact    33473751488      
Principal Investigator: Martin Soubrier         
Hopital Edouard Herriot Recruiting
Lyon, Rhône-Alpes, France, 69003
Contact    33472117482      
Principal Investigator: Roland Chapurlat         
Centre Hospitalier Le Mans Recruiting
Le Mans, Sarthe, France, 72000
Contact    33244710730      
Principal Investigator: Emmanuelle Dernis         
CHU d'Amiens-Picardie Hôpital Nord Recruiting
Amiens, France, 80084
Contact    33322087991      
Principal Investigator: Vincent Goeb         
Clinique de l'infirmerie Protestante Recruiting
Caluire-et-Cuire, France, 69300
Contact    0472007152      
Principal Investigator: André Basch         
Chu de Grenoble Hopital Sud Recruiting
Grenoble Cedex 9, France, 38042
Contact    33476765458      
Principal Investigator: Athan Charles Baillet         
Hopital de la Pitie Salpetriere Recruiting
Paris, France, 75013
Contact    33142177620      
Principal Investigator: Bruno Fautrel         
Centre Hospitalier Sud Francilien Recruiting
Corbeil-Essonnes, Île-de-France, France, 91106
Contact    33161697610      
Principal Investigator: Pascal Hilliquin         
Germany
Universitätsklinikum Freiburg Recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact    4976127074490      
Principal Investigator: Stephanie Finzel         
Internistisch-rheumatologische Praxisgemeinschaft Bayreuth Recruiting
Bayreuth, Bayern, Germany, 95444
Contact    49921764140      
Principal Investigator: Wolfgang Ochs         
Internistisch-rheumatologische Praxisgemeinschaft Bayreuth Recruiting
Bayreuth, Bayern, Germany, 95444
Contact    49921764140      
Principal Investigator: Matthias Schmitt-Haendle         
Universitätsklinikum Würzburg Recruiting
Würzburg, Bayern, Germany, 97080
Contact    4993120140100      
Principal Investigator: Hans-Peter Tony         
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact    496963017302      
Principal Investigator: Michaela Koehm         
Rheumapraxis an der Hase Recruiting
Osnabrück, Lower Saxony, Germany, 49074
Contact    49541358580      
Principal Investigator: Georg Gauler         
Rheumazentrum Prof. Neeck Recruiting
Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
Contact    493820373190      
Principal Investigator: Gunther Neeck         
Rheumatologische Facharztpraxis Schwerin Not yet recruiting
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Contact    004938520271077      
Principal Investigator: Christian Kneitz         
Gemeinschaftspraxis Dres. von Hinüber/Demary Recruiting
Hildesheim, Niedersachsen, Germany, 31134
Contact    049051211748466      
Principal Investigator: Ulrich von Hinüber         
Universitätsklinikum Köln Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact    00492214785623      
Principal Investigator: David Kofler         
Rheumazentrum Ratingen Recruiting
Ratingen, Nordrhein-Westfalen, Germany, 40878
Contact    4921025533788      
Principal Investigator: Siegfried Wassenberg         
Institut f. Präventive Medizin & Klinische Forschung Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39110
Contact    493917391531      
Principal Investigator: Rüdiger Möricke         
Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum Recruiting
Dresden, Sachsen, Germany, 01067
Contact    493514801400      
Principal Investigator: Leonore Unger         
Universität Leipzig - Universitätsklinikum Recruiting
Leipzig, Sachsen, Germany, 04103
Contact    00493419713263      
Principal Investigator: Ulf Wagner         
M&I Fachklinik Bad Pyrmont Not yet recruiting
Bad Pyrmont, Germany, 31812
Contact    490528162101025      
Principal Investigator: Dirk Meyer-Olson         
Praxis für Rheumatologie und Innere Medizin Recruiting
Berlin, Germany, 12163
Contact    0049307935485      
Principal Investigator: Kirsten Karberg         
Schlosspark-Klinik Recruiting
Berlin, Germany, 14059
Contact    00491714949907      
Principal Investigator: Rieke Alten         
Schön Klinik Hamburg Eilbek Recruiting
Hamburg, Germany, 20095
Contact    004940323103166      
Principal Investigator: Andrea Everding         
HRF Hamburger Rheuma Forschungszentrum Recruiting
Hamburg, Germany, 22391
Contact    4904069797022      
Principal Investigator: Hauke Heintz         
Greece
Laiko General Hospital of Athens Recruiting
Ampelokipoi, Attica, Greece, 11527
Contact    00302132061061      
Principal Investigator: Petros Sfikakis         
Laiko General Hospital of Athens Recruiting
Ampelokipoi, Attica, Greece, 11527
Contact    00302107462513      
Principal Investigator: Athanasios Tzioufas         
University General Hospital of Alexandroupolis Recruiting
Alexandroupolis, Greece, 68100
Contact    00302551353000      
Principal Investigator: Charalampos Papagoras         
Attikon' University Hospital Recruiting
Haidari/Athens, Greece, 12462
Contact    00302105831935      
Principal Investigator: Dimitrios T Boumpas         
Ippokrateio General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 54642
Contact    302310992816      
Principal Investigator: Alexandros Garyfallos         
Hungary
CRU Hungary Ltd. Recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Contact    36703426746      
Principal Investigator: Renata Kun         
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz Recruiting
Debrecen, Hajdu-Bihar, Hungary, 4031
Contact    302192021      
Principal Investigator: Janos Gaal         
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum Recruiting
Debrecen, Hajdu-Bihar, Hungary, 4032
Contact    36304883630      
Principal Investigator: Szilvia Szamosi         
Komarom-Eszetergom Megyei Onkormanyzat Szent Borbala Korhaza Recruiting
Tatabanya, Komarom-Esztergom, Hungary, 2800
Contact    36205693358      
Principal Investigator: Erika Simon         
Revita Reumatologiai Kft. Recruiting
Budapest, Pest, Hungary, 1027
Contact    +36702489239      
Principal Investigator: Regina Cseuz         
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. Recruiting
Budapest, Hungary, 1033
Contact    36706064462      
Principal Investigator: Eszter Simoncsics         
Vital Medical Center Recruiting
Veszprem, Hungary, 8200
Contact    3688790434      
Principal Investigator: Edit Drescher         
Israel
Meir Medical Center Recruiting
Kfar Saba, HaMerkaz, Israel, 4428164
Contact    97297471524      
Principal Investigator: Yair Levy         
Sheba Medical Center Recruiting
Ramat Gan, HaMerkaz, Israel, 5262100
Contact    97235302156      
Principal Investigator: Merav Lidar         
Barzilai Medical Center Recruiting
Ashkelon, Israel, 7830604
Contact    97286746175      
Principal Investigator: Tatiana Reitblat         
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact    0506267284      
Principal Investigator: Gleb Slobodin         
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact    97248250486      
Principal Investigator: Devy Zisman         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Contact    97236973776      
Principal Investigator: Ori Elkayam         
Rambam Health Care Campus Recruiting
Haifa, Ḥeifā, Israel, 3109601
Contact    97247771369      
Principal Investigator: Yolanda Braun Moscovici         
Italy
Policlinico di Tor Vergata Recruiting
Rome, Lazio, Italy, 00133
Contact    0620908469      
Principal Investigator: Roberto Perricone         
ASST Fatebenefratelli - Ospedale Luigi Sacco Not yet recruiting
Milan, Milano, Italy, 20157
Contact    39239042208      
Principal Investigator: Piercarlo Sarzi Puttini         
Nuovo Policlinico "Le Scotte" Recruiting
Siena, Toscana, Italy, 53100
Contact    3356272298      
Principal Investigator: Bruno Frediani         
ASL1 Avezzano-Sulmona-L'Aquila Not yet recruiting
Abruzzo, Italy, 67100
Contact    00390862434742      
Principal Investigator: Roberto Giacomelli         
Fondazione Universitaria degli Studi G D'Annunzio Not yet recruiting
Chieti, Italy, 66100
Contact    3389556036      
Principal Investigator: Francesco Cipollone         
Azienda Ospedaliera Universitaria Careggi Not yet recruiting
Firenze, Italy, 50141
Contact    390557946457      
Principal Investigator: Marco Matucci Cerinic         
Istituto Ortopedico Gaetano Pini Recruiting
Milano, Italy, 20122
Contact    390258296699      
Principal Investigator: Luigi Sinigaglia         
Università degli studi della Campania Luigi Vanvitelli Recruiting
Napoli, Italy, 80131
Contact    393201919055      
Principal Investigator: Francesco Ciccia         
Ospedale San Giovanni Bosco Recruiting
Torino, Italy, 10154
Contact    00393357552089      
Principal Investigator: Dario Roccatello         
Ospedale Policlinico Giambattista Rossi, Borgo Roma Recruiting
Verona, Italy, 37134
Contact    390458128035      
Principal Investigator: Ombretta Viapiana         
Lithuania
Republican Hospital of Kaunas Not yet recruiting
Kaunas, Kauno Miestas, Lithuania, 45130
Contact    37069801394      
Principal Investigator: Joana Dambrauskiene         
Klaipedos Universitetine Ligonine Not yet recruiting
Klaipeda, Klaipėdos Miestas, Lithuania, 92288
Contact    37046396535      
Principal Investigator: Loreta Bukauskiene         
Dr. Kildos Klinika Not yet recruiting
Kaunas, Lithuania, LT-50128
Contact    37061037838      
Principal Investigator: Dalia Unikiene         
Respublikine Siauliu Ligonine Not yet recruiting
Siauliai, Lithuania, LT-76231
Contact    37068678245      
Principal Investigator: Vida Basijokiene         
Centro Poliklinika Not yet recruiting
Vilnius, Lithuania, 01117
Contact    37069935268      
Principal Investigator: Ruta Lauciuviene         
Netherlands
Medisch Centrum Leeuwarden, locatie Leeuwarden Recruiting
Leeuwarden, Fryslân, Netherlands, 8934 AD
Contact    00310582866100      
Principal Investigator: Reinhard Bos         
PreCare Trial & Recruitment Recruiting
Beek, Limburg, Netherlands, 6191 JW
Contact    31464758687      
Principal Investigator: Vivienne van de Walle         
Erasmus Medisch Centrum Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Contact    653995477      
Principal Investigator: Pascal De Jong         
Maasstadziekenhuis Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3079DZ
Contact    0031102912205      
Principal Investigator: Annemiek Willemze         
Reade, center for Rehabilitation and Rheumatology Recruiting
Amsterdam, Netherlands, 1056 AB
Contact    31202421823      
Principal Investigator: Mike T. Nurmohamed         
Poland
Nasz Lekarz Przychodnie Medyczne Recruiting
Torun, Kujawsko-pomorskie, Poland, 87-100
Contact    48566539355      
Principal Investigator: Slawomir Jeka         
Lecznica MAK-MED, NZOZ Recruiting
Nadarzyn, Mazowieckie, Poland, 05-830
Contact    48505129307      
Principal Investigator: Marek Krogulec         
ETG Warszawa Recruiting
Warsaw, Mazowieckie, Poland, 02-777
Contact    48575000243      
Principal Investigator: Anna Rowinska-Osuch         
Medycyna Kliniczna Recruiting
Warszawa, Mazowieckie, Poland, 00-874
Contact    48606523522      
Principal Investigator: Agnieszka Zielinska         
Osteo Medic sc A. Racewicz, J. Supronik Recruiting
Bialystok, Podlaskie, Poland, 15-351
Contact    486749013      
Principal Investigator: Artur Racewicz         
Centrum Badan Klinicznych, PI House Recruiting
Gdansk, Pomorskie, Poland, 80-546
Contact    48603224313      
Principal Investigator: Zenobia Czuszynska         
Ambulatorium Barbara Bazela Recruiting
Elblag, Warminsko-Mazurki, Poland, 82300
Contact    +48608202021      
Principal Investigator: Barbara Bazela         
Prywatna Praktyka Lekarska P. Hrycaj Recruiting
Poznan, Wielkopolskie, Poland, 61-397
Contact    +48618750888      
Principal Investigator: Pawel Hrycaj         
Szpital Uniwersytecki nr 2 im. dr J. Biziela Recruiting
Bydgoszcz, Poland, 85-168
Contact    48523714912      
Principal Investigator: Rafal Wojciechowski         
Nzoz Bif-Med Recruiting
Bytom, Poland, 41-902
Contact    48508270636      
Principal Investigator: Hanna Mastalerz         
Centrum Medyczne Pratia Katowice Recruiting
Katowice, Poland, 40-081
Contact    48604215132      
Principal Investigator: Tomasz Dziewit         
Twoja Przychodnia-Centrum Medyczne Nowa Sol Recruiting
Nowa Sol, Poland, 67-100
Contact    48684177519      
Principal Investigator: Malgorzata Miakisz         
AI Centrum Medyczne Recruiting
Poznan, Poland, 61-113
Contact    48618411724      
Principal Investigator: Anna Rychlewska-Hanczewska         
Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim Recruiting
Tomaszów Lubelski, Poland, 22-600
Contact    48846644411      
Principal Investigator: Andrzej Kaminski         
Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci IM. Gen.J.Zietka Recruiting
Ustron, Poland, 43-450
Contact    48604752460      
Principal Investigator: Aleksandra Zon-Giebel         
Rheuma Medicus Zakład Opieki Zdrowotnej Recruiting
Warszawa, Poland, 02-118
Contact    48501792039      
Principal Investigator: Maria Rell-Bakalarska         
Reumatika Centrum Reumatologii Recruiting
Warszawa, Poland, 02-691
Contact    48784969702      
Principal Investigator: Janusz Jaworski         
Centrum Medyczne AMED Recruiting
Warszawa, Poland, 03-291
Contact    48224004041      
Principal Investigator: Anna Dudek         
Puerto Rico
Centro Reumatologico de Caguas Recruiting
Caguas, Puerto Rico, 00725
Contact    7872868465      
Principal Investigator: Amarilis Perez-De Jesus         
Ponce School of Medicine CAIMED Center Recruiting
Ponce, Puerto Rico, 00716
Contact    7878402505      
Principal Investigator: Ramon Toro-Torres         
Latin Clinical Trial Center Recruiting
San Juan, Puerto Rico, 00909
Contact    7872494763      
Principal Investigator: Carlos A Pantojas         
GCM Medical Group PSC Recruiting
San Juan, Puerto Rico, 00917
Contact    17877268396      
Principal Investigator: Karina Vila-Rivera         
Mindful Medical Research Recruiting
San Juan, Puerto Rico, 00918
Contact    7877659034      
Principal Investigator: Oscar Soto-Raices         
Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL Recruiting
Brasov, Brașov, Romania, 500283
Contact    40740072151      
Principal Investigator: Liliana Duca         
CMI Cristei Dorica Recruiting
Braila, Brăila, Romania, 810019
Contact    0040744768348      
Principal Investigator: Dorica Cristei         
RK Medcenter Recruiting
Iasi, Iași, Romania, 707027
Contact    40749254254      
Principal Investigator: Adriana Ciornohuz         
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Recruiting
Baia Mare, Maramures, Romania, 430031
Contact    40740083983      
Principal Investigator: Adriana Voie         
Spitalul Clinic Judetean de Urgenta Targu Mures Not yet recruiting
Tg.Mures, Mureș, Romania, 540136
Contact    40722339091      
Principal Investigator: Mirela Parvu         
Spitalul Clinic Sf Maria Bucuresti Recruiting
Bucuresti, Sector 1, Romania, 011172
Contact    0040723236258      
Principal Investigator: Florian Berghea         
Spitalul Clinic Sf Maria Bucuresti Recruiting
Bucuresti, Sector 1, Romania, 011172
Contact    40212223519      
Principal Investigator: Daniela Opris-Belinski         
Sc Medaudio-Optica Srl Recruiting
Ramnicu Valcea, Valcea, Romania, 240762
Contact    0040733293027      
Principal Investigator: Razvan Constantin Ionitescu         
Euroclinic Hospital Recruiting
Bucharest, Romania, 14461
Contact    0040737067719      
Principal Investigator: Horia Chicos         
Policlinica CCBR S.R.L. Not yet recruiting
Bucuresti, Romania, 30463
Contact    0040726199581      
Principal Investigator: Sorica Mustatea         
Spitalul Clinic Judetean de Urgenta "Sf.Apostol Andrei" Compartimentul Reumatologie Recruiting
Galati, Romania, 800578
Contact    40744795898      
Principal Investigator: Mariana Pavel         
Russian Federation
Kursk Regional Clinical Hospital Recruiting
Kursk, Kurskaya Oblast, Russian Federation, 305007
Contact    79103102827      
Principal Investigator: Larisa Knyazeva         
Leningrad Regional Clinical Hospital Recruiting
St. Petersburg, Leningradskaya Oblast, Russian Federation, 194291
Contact    78125923088      
Principal Investigator: Elena Ilivanova         
First Moscow State Medical University n.a. Sechenov Recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 119991
Contact    74992481511      
Principal Investigator: Irina V Menshikova         
M. F. Vladimirskiy Moscow Regional Research Clinical Institute Recruiting
Moscow, Moskva, Russian Federation, 129110
Contact    79166920666      
Principal Investigator: Marina L Stanislav         
City Clinical Hospital #5 Recruiting
Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603005
Contact    783144360517      
Principal Investigator: Elena Grunina,         
City Rheumatology Center (City Hospital #25) Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 190068
Contact    78123108248      
Principal Investigator: Galina Matsievskaya         
North-Western State Med. Univ. n.a. I.I. Mechnikov of MoH of Recruiting
St. Petersburg, Sankt-Peterburg, Russian Federation, 191015
Contact    79219517188      
Principal Investigator: Vadim Mazurov         
Ulyanovsk Regional Clinical Hospital Recruiting
Ulyanovsk, Ul'yanovskaya Oblast, Russian Federation, 432063
Contact    78422323246      
Principal Investigator: Irina Vinogradova         
Moscow Clinical Research Center Recruiting
Moscow, Russian Federation, 111123
Contact    79099551562      
Principal Investigator: Galina Lukina         
V.A. Nasonova Research Institute of Rheumatology Recruiting
Moscow, Russian Federation, 115522
Contact    74951092910      
Principal Investigator: Aleksander Lila         
City Clinical Hospital #1 n.a. N.I.Pirogov Recruiting
Moscow, Russian Federation, 119049
Contact    74955369233      
Principal Investigator: Evgeniya Shmidt         
Republican Hospital named after V.A. Baranov Recruiting
Petrozavodsk, Russian Federation, 185019
Contact    78142764923      
Principal Investigator: Irina Marusenko         
Ryazan Regional Clinincal Cardiology Dispensary Recruiting
Ryazan, Russian Federation, 390026
Contact    74912768406      
Principal Investigator: Sergey Yakushin         
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410053
Contact    78452491437      
Principal Investigator: Andrey Rebrov         
Tula Regional Clinical Hospital Recruiting
Tula, Russian Federation, 300053
Contact    84872486065      
Principal Investigator: Tatiana Salnikova         
Research & Practice Ltd Recruiting
Yaroslavl, Russian Federation, 150003
Contact    79159604246      
Principal Investigator: Olga Ershova         
Slovakia
ALBAMED s.r.o. Recruiting
Zvolen, Banskobystrický Kraj, Slovakia, 960 01
Contact    421907835646      
Principal Investigator: Silvia Ciernik         
ROMJAN s.r.o. Recruiting
Bratislava, Bratislavský Kraj, Slovakia, 851 01
Contact    421911900330      
Principal Investigator: Roman Jancovic         
Artromac n.o. Recruiting
Kosice, Slovakia, 040 11
Contact    0907705553      
Principal Investigator: Zelmíra Macejová         
Reumacentrum, s.r.o Recruiting
Partizanske, Slovakia, 95801
Contact    421385301005      
Principal Investigator: Livia Bruskova         
REUMED, s.r.o Recruiting
Spisska Nova Ves, Slovakia, 05201
Contact    421534199406      
Principal Investigator: Lenka Visnovska         
Leram, s.r.o. Recruiting
Topolcany, Slovakia, 95501
Contact    421385328502      
Principal Investigator: Eva Ladicka         
South Africa
Greenacres Hospital Not yet recruiting
Port Elizabeth, Eastern Cape, South Africa, 6057
Contact    27413635018      
Principal Investigator: Jenny Potts         
Parexel Not yet recruiting
Bloemfontein, Free State, South Africa, 9300
Contact    0514103091      
Principal Investigator: Eduard Krantz         
IATROS International Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Contact    27514440037      
Principal Investigator: Nyda Fourie         
Clinresco Centres (Pt) Ltd Not yet recruiting
Kempton Park, Gauteng, South Africa, 1619
Contact    027113943400      
Principal Investigator: Thomas Coetzer         
Steve Biko Academic Hospital Not yet recruiting
Pretoria, Gauteng, South Africa, 0001
Contact    27123192166      
Principal Investigator: Sophie Mathijs         
Chris Hani Baragwanath Hospital Not yet recruiting
Soweto, Gauteng, South Africa, 1864
Contact    0027762765930      
Principal Investigator: Kavita Makan         
Randles Road Medical Centre Not yet recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Contact    270312075252      
Principal Investigator: Uttam Govind         
NetCare Private Hosptial Not yet recruiting
Umhlanga, Kwazulu-Natal, South Africa, 4320
Contact    031566939      
Principal Investigator: Asokan Naidoo         
Precise Clinical Solutions (Pty) Ltd Not yet recruiting
Durban, KZ-Natal, South Africa, 4092
Contact    0314006756      
Principal Investigator: Visvakuren Naidoo         
Arthritis Clinical Research Trial Unit Not yet recruiting
Pinelands, Western Cape, South Africa, 7405
Contact    27215106638      
Principal Investigator: Catherine Spargo         
University Of Pretoria Not yet recruiting
Pretoria, South Africa, 0002
Contact    27123192166      
Principal Investigator: Sophie Mathijs         
Winelands Medical Research Centre Not yet recruiting
Stellenbosch, South Africa, 7600
Principal Investigator: Gareth Tarr         
Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03203
Contact    34966616742      
Principal Investigator: FRANCISCO JAVIER NAVARRO BLASCO         
Hospital Marina Baixa Recruiting
Villajoyosa, Alicante, Spain, 03570
Contact    34630392500      
Principal Investigator: Jose Rosas Gomez De Salazar         
Clínica Sagrada Família Recruiting
Barcelona, Catalunya, Spain, 08022
Contact    0034932938159      
Principal Investigator: Violant Poca         
Corporació Sanitaria Parc Tauli Recruiting
Sabadell, Catalunya, Spain, 08208
Contact    937231010      
Principal Investigator: Antonio Gomez Centeno         
Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí Recruiting
Sant Joan Despi, Catalunya, Spain, 08970
Contact    34935531200      
Principal Investigator: Paula Valentina Estrada Alarcón         
Hospital Clinico Universitario de Santiago Recruiting
Santiago de Compostela, La Coruna, Spain, 15706
Contact    34981951036      
Principal Investigator: Antonio Mera Varela         
Hospital De Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28944
Contact    34916006288      
Principal Investigator: Raul Veiga Cabello         
Hospital Universitario De Getafe Recruiting
Getafe, Madrid, Spain, 28905
Contact    4 683-9360      
Principal Investigator: Jaime Zubieta Tabernero         
Hospital Puerta De Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact    34911917102      
Principal Investigator: Jose Campos         
Osi Bilbao-Basurto Recruiting
Bilbo, País Vasco, Spain, 48013
Contact    34944006000 6068      
Principal Investigator: Mº Luz Garcia Vivar         
Hospital Meixoeiro Recruiting
Vigo, Pontevedra, Spain, 36200
Contact    986811111      
Principal Investigator: Ceferino Barbazan Alvarez         
Complejo Hospitalario Universitario A Coruna Recruiting
A Coruña, Spain, 15006
Contact    981176399      
Principal Investigator: Francisco Blanco         
Hospital Quironsalud Barcelona- END Recruiting
Barcelona, Spain, 08023
Contact    34675175518      
Principal Investigator: Maria Llop Vilaltella         
Hospital Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact    957010107      
Principal Investigator: Alejandro Escudero Contreras         
Hospital Quirónsalud Córdoba Not yet recruiting
Córdoba, Spain, 14004
Contact    686515599      
Principal Investigator: Manuel Romero Jurado         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact    34917792851      
Principal Investigator: Jose Luis Pablos Alvarez         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact    34917277193      
Principal Investigator: Alejandro Balsa Criado         
Hospital Regional Universitario de Málaga Recruiting
Malaga, Spain, 29009
Contact    +34951290360      
Principal Investigator: Antonio Fernandez Nebro         
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41007
Contact    34600162262      
Principal Investigator: Jose Perez Venegas         
Hospital Infanta Luisa Recruiting
Sevilla, Spain, 41010
Contact    34954330856      
Principal Investigator: Juan Miguel Sanchez Burson         
Switzerland
University Hospital Basel - Rheumatology Recruiting
Basel, Basel-Stad, Switzerland, 4031
Contact    41613287481      
Principal Investigator: Diego Kyburz         
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact    0041714941439      
Principal Investigator: Andrea Rubbert-Roth         
Hôpital Cantonal Fribourg Recruiting
Fribourg, Switzerland, 1708
Contact    41263061900      
Principal Investigator: Jean Dudler         
Turkey
Ankara University Ibni Sina Hospital - Rheumatology Recruiting
Ankara, Turkey, 06230
Contact    905322711076      
Principal Investigator: Sebnem Ataman         
Hacettepe University Recruiting
Ankara, Turkey, 06230
Contact    00905324618805      
Principal Investigator: Ali Ihsan Ertenli         
Trakya University Faculty of Medicine Recruiting
Edirne, Turkey, 22030
Contact    902842357641      
Principal Investigator: Hakan Emmungil         
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Contact    905325229501      
Principal Investigator: Gulen Hatemi         
Istanbual University School of Medicine Recruiting
Istanbul, Turkey, 34390
Contact    902125340050      
Principal Investigator: Murat İnanç         
Marmara University Pendik Research and Training Hospital Recruiting
İstanbul, Turkey, 34899
Contact    00905323101210      
Principal Investigator: Nevsun Inanç         
Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi Recruiting
Izmir, Turkey, 35620
Contact    905055252005      
Principal Investigator: Servet Akar         
United Kingdom
Addenbrookes Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact    01223586518      
Principal Investigator: Andra Negoescu         
Royal Cornwall Hospital Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact    01872 253849      
Principal Investigator: David Hutchinson         
Derriford Hospital Recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact    01752430068      
Principal Investigator: Jonathan King         
Torbay Hospital Recruiting
Torquay, Devon, United Kingdom, TQ2 7AA
Contact    07817175460      
Principal Investigator: Catherine Elizabeth Gwynne         
Christchurch Hospital Recruiting
Christchurch, Dorset, United Kingdom, BH232JX
Contact    07725313208      
Principal Investigator: Jonathan Marks         
Hull Royal Infirmary Recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact    441482875875      
Principal Investigator: Yusuf Patel         
Broomfield Hospital Recruiting
Chelmsford, Essex, United Kingdom, CM2 5ET
Contact    01245515231      
Principal Investigator: Win Win Maw         
Princess Alexandra Hospital Not yet recruiting
Harlow, Essex, United Kingdom, CM20 1QX
Contact    441279444455      
Principal Investigator: Khalid Ahmed         
Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, P06 3LY
Contact    01705286000      
Principal Investigator: Ernest Wong         
Royal Free Hospital Recruiting
London, Hampstead, United Kingdom, NW3 2QG
Contact    0442073177544      
Principal Investigator: Voon Hong Ong         
Kings Mill Hospital Recruiting
Sutton In Ashfield, Nottinghamshire, United Kingdom, NG17 4JT
Contact    00441158231766      
Principal Investigator: David Andrew Walsh         
Whipps Cross University Hospital Recruiting
London, Surrey, United Kingdom, E11 1NR
Contact    +447917726149      
Principal Investigator: Stephen Kelly         
North Tyneside General Hospital Recruiting
North Shields, Tyneside, United Kingdom, NE29 8NH
Contact    448448118111      
Principal Investigator: Ismael Atchia         
The Dudley Group NHS Foundation Trust Recruiting
Dudley, West Midlands, United Kingdom, DY1 2HQ
Contact    01384244754      
Principal Investigator: Karen Douglas         
New Cross Hospital Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Contact    441902307999      
Principal Investigator: Sabrina Raizada         
Aintree Hospitals Recruiting
Liverpool, United Kingdom, L9 7AL
Contact    01515295889      
Principal Investigator: Nicola Goodson         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2JF
Contact    01142711937      
Principal Investigator: James Maxwell         
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03915964    
Other Study ID Numbers: 17172
I4V-MC-JAJA ( Other Identifier: Eli Lilly and Company )
2018-003351-37 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors