Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
849 participants
OBSERVATIONAL
2008-07-11
2024-02-01
Brief Summary
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Detailed Description
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Patients who discontinue from the registry before 10 years will be offered to participate in the direct to Health Care Provider follow-up process, as allowed by local regulations.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HUMIRA® Treatment Arm
For patients taking HUMIRA®
adalimumab
As prescribed by treating physician
Methotrexate Treatment Arm
For patients taking Methotrexate
Methotrexate
As prescribed by treating physician
Interventions
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adalimumab
As prescribed by treating physician
Methotrexate
As prescribed by treating physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled patients are 4 to 17 years of age as per approved HUMIRA® product label with the addition of JIA patients 2 to \< 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry.
* Newly initiated (within 24 months of registry entry) on HUMIRA® therapy and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy, and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy;
* Or is entering after participation (within 24 months of registry entry or, if longer, continuously treated at the same site) in an AbbVie Humira sponsored study, regardless of age or the number of joints with symptoms of JIA, and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
* For a patient enrolling into the MTX arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA (defined as arthritis affecting \>= 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA) who is prescribed MTX therapy alone or in combination with other disease modifying anti-rheumatic drugs (DMARDs) according to the local product labeling (initiated treatment within 24 months of registry entry) and has received continuous therapy and the physician can available provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
* Parent or guardian has voluntarily signed and dated an informed consent/patient authorization form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, after the nature of the registry has been explained and the patient's parent or legal guardian has had the opportunity to ask questions. Pediatric patients will be included in all discussions as per applicable local regulations in order to obtain verbal or written assent.
Exclusion Criteria
* Patients should not be enrolled into the HUMIRA® or MTX arm if they require on-going treatment with Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), Enbrel® (etanercept), and Remicade® (infliximab), or any other approved biologic agents or investigational agents.
* Patients should not be enrolled into the MTX arm if they have had prior treatment with any investigational agent or anti-rheumatic biologic therapy such as, but not limited to, Orencia® (abatacept), Enbrel® (etanercept), Remicade® (infliximab), Rituxan® (rituximab), or Actemra® (tocilizumab)
2 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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AZ Arthritis and Rheumotology Research, PLLC /ID# 21023
Phoenix, Arizona, United States
Catalina Pointe Clinical Research /ID# 40227
Tucson, Arizona, United States
Arkansas Children's Hospital /ID# 23505
Little Rock, Arkansas, United States
Children's Hospital Los Angeles /ID# 24386
Los Angeles, California, United States
Children's National Medical Center /ID# 23506
Washington D.C., District of Columbia, United States
Duplicate_Arthritis Associates South FL /ID# 17001
Delray Beach, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966
Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 21981
Chicago, Illinois, United States
Methodist Medical Group Rheum /ID# 46343
Peoria, Illinois, United States
Indiana University /ID# 11421
Indianapolis, Indiana, United States
University of Louisville /ID# 23507
Louisville, Kentucky, United States
Arthritis Care Spec. of MD /ID# 21961
Ellicott City, Maryland, United States
Tufts Medical Center /ID# 21965
Boston, Massachusetts, United States
Creighton Univ Med Ctr /ID# 11423
Omaha, Nebraska, United States
St. Barnabas Ambulatory Care /ID# 21025
West Orange, New Jersey, United States
North Shore University Hospital /ID# 21022
New Hyde Park, New York, United States
University of Rochester Medical Center /ID# 20967
Rochester, New York, United States
New York Medical College /ID# 21964
Valhalla, New York, United States
Duke Cancer Center /ID# 22904
Durham, North Carolina, United States
Bone Spine Sports/Medctr One /ID# 21962
Bismarck, North Dakota, United States
Akron Children's Hospital /ID# 22907
Akron, Ohio, United States
University of Cincinnati /ID# 14101
Cincinnati, Ohio, United States
Nationwide Children's Hospital /ID# 21963
Columbus, Ohio, United States
Legacy Emanuel Medical Center /ID# 14102
Portland, Oregon, United States
St. Christopher's Hospital /ID# 24385
Philadelphia, Pennsylvania, United States
Arthritis Associates of Kingsport /ID# 44462
Kingsport, Tennessee, United States
Dr. Ramesh Gupta /ID# 45342
Memphis, Tennessee, United States
Scott & White Health Care /ID# 36762
Round Rock, Texas, United States
University of Utah /ID# 21041
Salt Lake City, Utah, United States
Children's Speciality Center /ID# 11503
Burlington, Vermont, United States
Seattle Children's Hospital /ID# 20968
Seattle, Washington, United States
Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226
Milwaukee, Wisconsin, United States
Duplicate_Womens and Childrens Hospital /ID# 59182
Adelaide, South Australia, Australia
Medizinische Universitaet Graz /ID# 26126
Graz, Styria, Austria
Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 26127
Vienna, Vienna, Austria
Landeskrankenhaus Bregenz /ID# 26128
Bregenz, Vorarlberg, Austria
Fakultni Nemocnice Brno /ID# 37343
Brno, , Czechia
Revmatologicky ustav v Praze /ID# 43344
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 47401
Prague, , Czechia
Fakultni Nemocnice v Motole /ID# 37342
Prague, , Czechia
Aarhus University Hospital /ID# 25445
Aarhus N, Central Jutland, Denmark
Duplicate_Rigshospitalet, Finsen Centre /ID# 25444
Copenhagen, , Denmark
CHU Strasbourg - Hopital de Hautepierre /ID# 25450
Strasbourg, Bas-Rhin, France
Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454
Bordeaux, Gironde, France
CHRU Tours - Hopital Bretonneau /ID# 27126
Tours, Indre-et-Loire, France
CHRU Nancy - Hopitaux de Brabois /ID# 25452
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 25449
Lille, Nord, France
CHU Toulouse /ID# 37347
Toulouse, Occitanie, France
AP-HP - Hôpital Bicêtre /ID# 25443
Le Kremlin-Bicêtre, , France
Duplicate_AP-HP - Hopital Cochin /ID# 37345
Paris, , France
AP-HP - Hopital Necker /ID# 25442
Paris, , France
Duplicate_CHU de Rennes - Hospital Sud /ID# 27123
Rennes, , France
Universitaetsklinikum Tuebingen /ID# 39070
Tübingen, Baden-Wurttemberg, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623
Berlin, , Germany
Helios Klinikum Berlin-Buch /ID# 37348
Berlin, , Germany
Klinikum Bremen Mitte /ID# 45942
Bremen, , Germany
Klinikum Dortmund gGmbH /ID# 44003
Dortmund, , Germany
Center Rheumatology Child&Adol /ID# 39069
Garmisch-Patenkirchen, , Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223
Hamburg, , Germany
Klinikum St. Georg gGmbH /ID# 37349
Leipzig, , Germany
Asklepios Klinik Sankt Augustin /ID# 41622
Sankt Augustin, , Germany
Rheumazentrum Wedel /ID# 37350
Wedel, , Germany
Children's Hosp P. A. Kyriakou /ID# 25448
Athens, Attica, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 25447
Thessaloniki, , Greece
Debreceni Egyetem Klinikai Kozpont /ID# 95863
Debrecen, Hajdú-Bihar, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095
Budapest, , Hungary
Azienda Ospedaliero Universitaria Meyer /ID# 26123
Florence, Firenze, Italy
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074
Rome, Roma, Italy
Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077
Brescia, , Italy
Duplicate_Universita di Catania /ID# 39075
Catania, , Italy
Ospedale Ss. Annunziata /ID# 37353
Chieti, , Italy
Istituto Giannina Gaslini /ID# 26668
Genova, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124
Milan, , Italy
Duplicate_Universita di Napoli Federico II /ID# 39078
Naples, , Italy
Azienda Ospedaliera Universitaria Federico II /ID# 39072
Napoli, , Italy
Fondazione IRCCS Policlinico /ID# 39076
Pavia, , Italy
Universitair Medisch Centrum Utrecht /ID# 48842
Utrecht, , Netherlands
Oslo Universitetssykehus, Radiumhospitalet /ID# 46402
Oslo, , Norway
Hospital Garcia de Orta, EPE /ID# 37355
Almada, , Portugal
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682
Lisbon, , Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081
Porto, , Portugal
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047
Bayamón, , Puerto Rico
Puerto Rico Children Hospital /ID# 47742
Bayamón, , Puerto Rico
Narodny ustav reumatickych chorob /ID# 38102
Piešťany, , Slovakia
Hospital Sant Joan de Deu /ID# 37358
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Severo Ochoa /ID# 41751
Leganés, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 37357
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus /ID# 37360
Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 41624
Madrid, , Spain
Hospital Universitario y Politecnico La Fe /ID# 37359
Valencia, , Spain
Queen Silvia Children's Hosp /ID# 26125
Gothenburg, Västra Götaland County, Sweden
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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P10-262
Identifier Type: -
Identifier Source: org_study_id
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