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This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.
This registry will assess the incidence and rate of Humira (monotherapy or combination therapy with MTX) or MTX observational and treatment-emergent SAEs, Adverse Events of Special Interest (AESI) and Pregnancy in patients diagnosed with moderately to severely active polyarticular or polyarticular-course JIA through Year 5. From Year 6 through Year 10 SAEs, a subset of AESI that includes congestive heart failure (CHF), malignancies, AEs at least possibly related to and/or leading to discontinuation of registry treatment and pregnancies will be collected. For 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, emergent AESI, SAEs and pregnancy (at the age when a patient can become pregnant) will be collected for the full 10 years. The approved age range for HUMIRA in the U.S., European Union (EU) and in Australia is 4 years of age and older, and recent approval in EU for JIA patients 2 to < 4 years of age.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUMIRA® Treatment Arm | For patients taking HUMIRA® |
| |
| Methotrexate Treatment Arm | For patients taking Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | As prescribed by treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) | Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process. | Up to 10 years |
| Incidence of Adverse Events (AEs) of Interest | Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric American College of Rheumatology (PedACR) 50 | Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population. | Up to 10 years |
| Pediatric American College of Rheumatology (PedACR) 70 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA, (defined as arthritis affecting greater than 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA), prescribed and treated in a routine clinical setting either with Humira® (adalimumab), or MTX. Approximately 800 patients will be enrolled in the United States, EU countries, and Australia. Approximately 40 to 45 physicians will be included based on participation in prior AbbVie Humira sponsored clinical JIA studies.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Arthritis and Rheumotology Research, PLLC /ID# 21023 | Phoenix | Arizona | 85032-9306 | United States | ||
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| Methotrexate | Drug | As prescribed by treating physician |
|
|
Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
| Up to 10 years |
| Pediatric American College of Rheumatology (PedACR) - 30 | Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population. | Up to 10 years |
| Child Health Questionnaire (CHQ-PF50) | The results will be summarized at each visit and will be used in exploratory analyses. | Assessed in months 1,3, 6 and every 6 months through Year 5 |
| Pediatric American College of Rheumatology (PedACR) 90 | Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population. | Up to 10 years |
| Juvenile arthritis disease activity score (JADAS) | Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population. Is the total scores of four activity scales (Physician's Global Assessment of patient's disease, Parents' Global Assessment of patient's overall well-being, Number of active joints and Normalized erythrocyte sedimentation rate (ESR) if collected and available. | Assessed in months 1,3, 6 and every 6 months through Year 5 |
| Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ) | Effectiveness of therapy through clinical assessment. | Assessed in months 1,3, 6 and every 6 months through Year 5 |
| Catalina Pointe Clinical Research /ID# 40227 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Arkansas Children's Hospital /ID# 23505 | Little Rock | Arkansas | 72202 | United States |
| Children's Hospital Los Angeles /ID# 24386 | Los Angeles | California | 90027 | United States |
| Children's National Medical Center /ID# 23506 | Washington D.C. | District of Columbia | 20010-2916 | United States |
| Duplicate_Arthritis Associates South FL /ID# 17001 | Delray Beach | Florida | 33484 | United States |
| Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966 | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Center /ID# 21981 | Chicago | Illinois | 60637-1443 | United States |
| Methodist Medical Group Rheum /ID# 46343 | Peoria | Illinois | 61602 | United States |
| Indiana University /ID# 11421 | Indianapolis | Indiana | 46202 | United States |
| University of Louisville /ID# 23507 | Louisville | Kentucky | 40202 | United States |
| Arthritis Care Spec. of MD /ID# 21961 | Ellicott City | Maryland | 21042 | United States |
| Tufts Medical Center /ID# 21965 | Boston | Massachusetts | 02111-1552 | United States |
| Creighton Univ Med Ctr /ID# 11423 | Omaha | Nebraska | 68131 | United States |
| St. Barnabas Ambulatory Care /ID# 21025 | West Orange | New Jersey | 07052 | United States |
| North Shore University Hospital /ID# 21022 | New Hyde Park | New York | 11040 | United States |
| University of Rochester Medical Center /ID# 20967 | Rochester | New York | 14642 | United States |
| New York Medical College /ID# 21964 | Valhalla | New York | 10595 | United States |
| Duke Cancer Center /ID# 22904 | Durham | North Carolina | 27710-3000 | United States |
| Bone Spine Sports/Medctr One /ID# 21962 | Bismarck | North Dakota | 58501 | United States |
| Akron Children's Hospital /ID# 22907 | Akron | Ohio | 44308 | United States |
| University of Cincinnati /ID# 14101 | Cincinnati | Ohio | 45267-0585 | United States |
| Nationwide Children's Hospital /ID# 21963 | Columbus | Ohio | 43205-2664 | United States |
| Legacy Emanuel Medical Center /ID# 14102 | Portland | Oregon | 97227 | United States |
| St. Christopher's Hospital /ID# 24385 | Philadelphia | Pennsylvania | 19134 | United States |
| Arthritis Associates of Kingsport /ID# 44462 | Kingsport | Tennessee | 37660 | United States |
| Dr. Ramesh Gupta /ID# 45342 | Memphis | Tennessee | 38119 | United States |
| Scott & White Health Care /ID# 36762 | Round Rock | Texas | 78665 | United States |
| University of Utah /ID# 21041 | Salt Lake City | Utah | 84112-5500 | United States |
| Children's Speciality Center /ID# 11503 | Burlington | Vermont | 05401 | United States |
| Seattle Children's Hospital /ID# 20968 | Seattle | Washington | 98105 | United States |
| Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226 | Milwaukee | Wisconsin | 53226 | United States |
| Duplicate_Womens and Childrens Hospital /ID# 59182 | Adelaide | South Australia | 5006 | Australia |
| Medizinische Universitaet Wien /ID# 26127 | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universitaet Graz /ID# 26126 | Graz | Styria | 8010 | Austria |
| Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068 | Linz | Upper Austria | 4021 | Austria |
| Landeskrankenhaus Bregenz /ID# 26128 | Bregenz | Vorarlberg | 6900 | Austria |
| Fakultni Nemocnice Brno /ID# 37343 | Brno | 625 00 | Czechia |
| Revmatologicky ustav v Praze /ID# 43344 | Prague | 128 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze /ID# 47401 | Prague | 128 08 | Czechia |
| Fakultni Nemocnice v Motole /ID# 37342 | Prague | 150 06 | Czechia |
| Aarhus University Hospital /ID# 25445 | Aarhus N | Central Jutland | 8200 | Denmark |
| Duplicate_Rigshospitalet, Finsen Centre /ID# 25444 | Copenhagen | 2100 | Denmark |
| CHU Strasbourg - Hopital de Hautepierre /ID# 25450 | Strasbourg | Bas-Rhin | 67200 | France |
| Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454 | Bordeaux | Gironde | 33000 | France |
| CHRU Tours - Hopital Bretonneau /ID# 27126 | Tours | Indre-et-Loire | 37044 | France |
| CHRU Nancy - Hopitaux de Brabois /ID# 25452 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| CHRU Lille - Hopital Claude Huriez /ID# 25449 | Lille | Nord | 59037 | France |
| CHU Toulouse /ID# 37347 | Toulouse | Occitanie | 31300 | France |
| AP-HP - Hôpital Bicêtre /ID# 25443 | Le Kremlin-Bicêtre | 94270 | France |
| Duplicate_AP-HP - Hopital Cochin /ID# 37345 | Paris | 75014 | France |
| AP-HP - Hopital Necker /ID# 25442 | Paris | 75015 | France |
| Duplicate_CHU de Rennes - Hospital Sud /ID# 27123 | Rennes | 35203 | France |
| Universitaetsklinikum Tuebingen /ID# 39070 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623 | Berlin | 10117 | Germany |
| Helios Klinikum Berlin-Buch /ID# 37348 | Berlin | 13125 | Germany |
| Klinikum Bremen Mitte /ID# 45942 | Bremen | 28205 | Germany |
| Klinikum Dortmund gGmbH /ID# 44003 | Dortmund | 44137 | Germany |
| Center Rheumatology Child&Adol /ID# 39069 | Garmisch-Patenkirchen | 82467 | Germany |
| Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223 | Hamburg | 22081 | Germany |
| Klinikum St. Georg gGmbH /ID# 37349 | Leipzig | 04129 | Germany |
| Asklepios Klinik Sankt Augustin /ID# 41622 | Sankt Augustin | 53757 | Germany |
| Rheumazentrum Wedel /ID# 37350 | Wedel | 22880 | Germany |
| Children's Hosp P. A. Kyriakou /ID# 25448 | Athens | Attica | 11527 | Greece |
| General Hospital of Thessaloniki Hippokrateio /ID# 25447 | Thessaloniki | 54642 | Greece |
| Debreceni Egyetem Klinikai Kozpont /ID# 95863 | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095 | Budapest | 1023 | Hungary |
| Azienda Ospedaliero Universitaria Meyer /ID# 26123 | Florence | Firenze | 50139 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074 | Rome | Roma | 00165 | Italy |
| Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077 | Brescia | 25123 | Italy |
| Duplicate_Universita di Catania /ID# 39075 | Catania | 95123 | Italy |
| Ospedale Ss. Annunziata /ID# 37353 | Chieti | 66100 | Italy |
| Istituto Giannina Gaslini /ID# 26668 | Genova | 16147 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124 | Milan | 20122 | Italy |
| Azienda Ospedaliera Universitaria Federico II /ID# 39072 | Naples | 80131 | Italy |
| Duplicate_Universita di Napoli Federico II /ID# 39078 | Naples | 80131 | Italy |
| Fondazione IRCCS Policlinico /ID# 39076 | Pavia | 27100 | Italy |
| Universitair Medisch Centrum Utrecht /ID# 48842 | Utrecht | 3584 CX | Netherlands |
| Oslo Universitetssykehus, Radiumhospitalet /ID# 46402 | Oslo | 0310 | Norway |
| Hospital Garcia de Orta, EPE /ID# 37355 | Almada | 2805-267 | Portugal |
| Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682 | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081 | Porto | 4099-001 | Portugal |
| Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047 | Bayamón | 00959 | Puerto Rico |
| Puerto Rico Children Hospital /ID# 47742 | Bayamón | 00960 | Puerto Rico |
| Narodny ustav reumatickych chorob /ID# 38102 | Piešťany | 921 12 | Slovakia |
| Hospital Sant Joan de Deu /ID# 37358 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Severo Ochoa /ID# 41751 | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 37357 | Barcelona | 08035 | Spain |
| Hospital Infantil Universitario Nino Jesus /ID# 37360 | Madrid | 28009 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 41624 | Madrid | 28034 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 37359 | Valencia | 46026 | Spain |
| Queen Silvia Children's Hosp /ID# 26125 | Gothenburg | Västra Götaland County | 416 85 | Sweden |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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