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This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunosuppressant Therapy | Pediatric patients who are being prescribed and treated with immunosuppressant therapy | ||
| Adalimumab (Humira) Treatment | Pediatric patients who are prescribed and treated with adalimumab |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent AESI per 100 PYs of infections and malignancies | Up to 10 years | |
| Percentage of subjects with SAEs | Up to 10 years | |
| Number of treatment-emergent other AESI per 100 PYs | Up to 5 years | |
| Percentage of subjects with other AESI | Percentages of subjects with AESIs other than infections and malignancies | Up to 5 years |
| Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies | Up to 10 years | |
| Number of subjects with other AESI | Number of subjects with AESIs other than infections and malignancies | Up to 5 years |
| Number of treatment-emergent SAEs per 100 patient years (PYs) | Up to 10 years | |
| Number of subjects with Serious Adverse Events (SAEs) | Up to 10 years | |
| Percentage of subjects with AESI of infections, malignancies, and pregnancies | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) | Patient completed questionnaires | Up to 5 years |
| Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) | Completed by the patients who are 18 years of age or older |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with moderately to severely active Crohn's Disease (CD) who have been prescribed HUMIRA according to the local label and pediatric patients being prescribed and treated with IMM (azathioprine, 6-mercaptopurine, or methotrexate). Patients being prescribed and treated with immunosuppressant therapy with no concurrent biologic use will be enrolled as a reference group.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ Alabama, Birmingham CCC /ID# 146060 | Birmingham | Alabama | 35294-3300 | United States | ||
| University of South Alabama /ID# 137255 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Up to 5 years |
| Work Productivity and Activity Impairment (WPAI) questionnaire | Completed by caregiver up to the age of 17 years and completed by the patients of age 18 years or above. | Up to 5 years |
| Physician's Global Assessment of Disease Activity (PGA) | Completed by the physician | Up to 5 years |
| IMPACT III | Completed by patients ages 10 through 17 years old | Up to 5 years |
| Mobile |
| Alabama |
| 36617 |
| United States |
| Phoenix Children's Hospital /ID# 141336 | Phoenix | Arizona | 85016-7710 | United States |
| Children's Hospital Los Angeles /ID# 141551 | Los Angeles | California | 90027 | United States |
| Private practice: Dr. Shervin Rabizadeh /ID# 137269 | Los Angeles | California | 90048 | United States |
| Rady Children's Hospital San Diego /ID# 140883 | San Diego | California | 92123 | United States |
| Univ California, San Francisco /ID# 141312 | San Francisco | California | 94143-2204 | United States |
| Children's Hospital Colorado - Aurora /ID# 137261 | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center - Hartford /ID# 137265 | Hartford | Connecticut | 06106 | United States |
| Yale University School of Medicine /ID# 137257 | New Haven | Connecticut | 06510 | United States |
| Nemours Children's Health System /ID# 148498 | Jacksonville | Florida | 32207 | United States |
| University of Miami /ID# 140893 | Miami | Florida | 33136 | United States |
| Winship Cancer Institute of Emory University /ID# 144274 | Atlanta | Georgia | 30322 | United States |
| Children's Ctr Digestive, US /ID# 144625 | Atlanta | Georgia | 30342 | United States |
| Children's Hospital New Orleans /ID# 144477 | New Orleans | Louisiana | 70118 | United States |
| Maine Medical Partners /ID# 147685 | Portland | Maine | 04102 | United States |
| Tufts Medical Center /ID# 143581 | Boston | Massachusetts | 02111-1552 | United States |
| Massachusetts General Hospital /ID# 141552 | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital /ID# 164102 | Boston | Massachusetts | 02115 | United States |
| Duplicate_UMass Chan Medical School /ID# 148325 | Worcester | Massachusetts | 01655 | United States |
| M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238 | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic - Rochester /ID# 149245 | Rochester | Minnesota | 55905-0001 | United States |
| Univ of Mississippi Med Ctr,US /ID# 137239 | Jackson | Mississippi | 39216-4643 | United States |
| Goryeb Children's Hospital /ID# 144275 | Morristown | New Jersey | 07960 | United States |
| Women and Childrens Hosp /ID# 143778 | Buffalo | New York | 14222 | United States |
| CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266 | New Hyde Park | New York | 11042-2057 | United States |
| Columbia Univ Medical Center /ID# 144440 | New York | New York | 10032-3725 | United States |
| Columbia Univ Medical Center /ID# 144475 | New York | New York | 10032-3725 | United States |
| Univ Med Ctr at Stony Brook /ID# 140913 | Stony Brook | New York | 11794 | United States |
| SUNY Upstate Medical University /ID# 148437 | Syracuse | New York | 13210 | United States |
| Univ NC Chapel Hill /ID# 137236 | Chapel Hill | North Carolina | 27514-4220 | United States |
| Duke Cancer Center /ID# 137268 | Durham | North Carolina | 27710-3000 | United States |
| Children's Hospital Oklahoma /ID# 144047 | Oklahoma City | Oklahoma | 73104 | United States |
| Geisinger Medical Center /ID# 149910 | Danville | Pennsylvania | 17822 | United States |
| Penn State Child Hosp.Hersh,PA /ID# 144476 | Hershey | Pennsylvania | 17033 | United States |
| Duplicate_Medical University of South Carolina /ID# 144473 | Charleston | South Carolina | 29425 | United States |
| Children's Medical Center /ID# 149256 | Dallas | Texas | 75235 | United States |
| Cook Children's Med. Center /ID# 144474 | Fort Worth | Texas | 76104 | United States |
| Texas Children's Hospital /ID# 148211 | Houston | Texas | 77030-2608 | United States |
| University Of Vermont Medical /ID# 137263 | Burlington | Vermont | 05405 | United States |
| Pediatric Specialty of VA /ID# 142831 | Fairfax | Virginia | 22031 | United States |
| Duplicate_Swedish Medical Center /ID# 137258 | Seattle | Washington | 98104 | United States |
| Seattle Children's Hospital /ID# 140879 | Seattle | Washington | 98105 | United States |
| MultiCare Institute for Research & Innovation /ID# 152120 | Tacoma | Washington | 98405 | United States |
| Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259 | Milwaukee | Wisconsin | 53226 | United States |
| University Clinical Center Tuzla /ID# 130638 | Tuzla | Tuzlanski | 75000 | Bosnia and Herzegovina |
| SHAT Hematologic Diseases /ID# 143572 | Sofia | 1797 | Bulgaria |
| Alberta Health Services /ID# 128717 | Edmonton | Alberta | T6G 1C9 | Canada |
| Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310 | Winnipeg | Manitoba | R3E 3P4 | Canada |
| IWK Health Center /ID# 127912 | Halifax | Nova Scotia | B3K 6R8 | Canada |
| The Univ of Western Ontario /ID# 137962 | London | Ontario | N6A 5K8 | Canada |
| Hospital for Sick Children /ID# 127910 | Toronto | Ontario | M5G 1X8 | Canada |
| Klinicki bolnicki centar Sestre milosrdnice /ID# 128256 | Zagreb | City of Zagreb | 10000 | Croatia |
| Zadar General Hospital /ID# 129830 | Zadar | 23000 | Croatia |
| Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521 | Hradec Králové | Hradec Kralove | 500 05 | Czechia |
| Fakultni Nemocnice Ostrava /ID# 127913 | Ostrava | Ostrava-mesto | 708 52 | Czechia |
| Fakultni nemocnice Olomouc /ID# 127437 | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady /ID# 127697 | Prague | 100 34 | Czechia |
| Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829 | Ústí nad Labem | 401 13 | Czechia |
| Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013 | Hvidovre | Capital Region | 2650 | Denmark |
| Tallinn Children's Hospital /ID# 126974 | Tallinn | Harju | 13419 | Estonia |
| Children's Clinic Of Tartu Uni /ID# 146017 | Tartu | Tartu | 51014 | Estonia |
| Duplicate_Hôpital Pierre Wertheimer /ID# 128193 | Bron | Rhone | 69677 | France |
| AP-HP - Hopital Necker /ID# 147702 | Paris | 75015 | France |
| Universitaetsklinikum Ulm /ID# 148444 | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Duplicate_Universitaetsklinikum Erlangen /ID# 137274 | Erlangen | Bavaria | 91054 | Germany |
| Duplicate_Universitaetsklinikum Muenster /ID# 148441 | Munster | Lower Saxony | 48149 | Germany |
| Christliches Kinderhospital Osnabrueck /ID# 136629 | Osnabrück | Lower Saxony | 49074 | Germany |
| Universitaetsklinikum Aachen /ID# 126591 | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696 | Dresden | Saxony | 01307 | Germany |
| Froehlich Gemeinschaftspraxis /ID# 127975 | Forchheim | 91301 | Germany |
| Duplicate_Universitaetsklinikum Freiburg /ID# 130010 | Freiburg im Breisgau | 79106 | Germany |
| Kinderarztpraxis Neuhausen /ID# 144402 | Munich | 80634 | Germany |
| Universitaetsklinikum Regensburg /ID# 137140 | Regensburg | 93042 | Germany |
| Agia Sofia Hospital /ID# 134349 | Athens | Attica | 11527 | Greece |
| General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690 | Athens | Attica | 11527 | Greece |
| Iatriko Kentro Athinon /ID# 130639 | Marousi | Attica | 15125 | Greece |
| Venizeleio General Hospital /ID# 147335 | Heraklion | 71409 | Greece |
| General Hospital of Thessaloniki Gennimatas /Id# 163658 | Thessaloniki | 54635 | Greece |
| Our Lady's Hospital /ID# 127438 | Manorhamilton | Leitrim | Ireland |
| Schneider Children's Medical Center /ID# 152683 | Petah Tikva | Central District | 4920235 | Israel |
| Duplicate_Kaplan Medical Center /ID# 152945 | Rehovot | Central District | 7661041 | Israel |
| Yitzhak Shamir Medical Center /ID# 157182 | Ẕerifin | Central District | 70300 | Israel |
| Shaare Zedek Medical Center /ID# 144277 | Jerusalem | Jerusalem | 91031 | Israel |
| Edmond And Lily Safra Children /ID# 148730 | Ramat Gan | Tel Aviv | 5262100 | Israel |
| Duplicate_Ha'Emek Medical Center /ID# 156316 | Afula | 18341 | Israel |
| Rambam Health Care Campus /ID# 162061 | Haifa | 3109601 | Israel |
| The Lady Davis Carmel Medical Center /ID# 151519 | Haifa | 34362 | Israel |
| ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279 | Milan | Milano | 20122 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962 | Rome | Roma | 00161 | Italy |
| Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347 | Bologna | 40133 | Italy |
| Duplicate_A.O.U. Policlinico G. Martino /ID# 141683 | Messina | 98125 | Italy |
| ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679 | Milan | 20154 | Italy |
| Duplicate_Universita di Napoli Federico II /ID# 144280 | Naples | 80131 | Italy |
| Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410 | Palermo | 90127 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684 | Palermo | 90146 | Italy |
| Azienda Ospedaliero-Universitaria di Parma /ID# 147441 | Parma | 43126 | Italy |
| Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307 | Pescara | 65124 | Italy |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809 | Kaunas | 50161 | Lithuania |
| Vilnius University Hospital Santaros Klinikos /ID# 127810 | Vilnius | 08661 | Lithuania |
| Duplicate_Academisch Medisch Centrum /ID# 141843 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Duplicate_Erasmus Medisch Centrum /ID# 141841 | Rotterdam | South Holland | 3015 GD | Netherlands |
| 2CA-Braga, Hospital de Braga /ID# 138269 | Braga | 4710-243 | Portugal |
| Unidade Local de Saude Sao Joao, EPE /ID# 138146 | Porto | 4200-319 | Portugal |
| Ctr. Gastroenterologia Ped Oes /ID# 140875 | Mayagüez | 00680 | Puerto Rico |
| San Jorge Children Hospital /ID# 138067 | San Juan | 00912-3310 | Puerto Rico |
| Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297 | Cluj-Napoca | Cluj | 400177 | Romania |
| Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251 | Timișoara | Timiș County | 500063 | Romania |
| Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358 | Bucharest | 011743 | Romania |
| Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014 | Târgu Mureş | 540136 | Romania |
| Complejo Hospitalario Universitario A Coruña /ID# 137235 | A Coruña | A Coruna | 15006 | Spain |
| Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462 | Ferrol | A Coruna | 15405 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 141667 | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitari Son Espases /ID# 147446 | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Universitario Germans Trias i Pujol /ID# 139400 | Badalona | Barcelona | 08916 | Spain |
| Hospital Sant Joan de Deu /ID# 152059 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029 | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Severo Ochoa /ID# 141545 | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872 | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460 | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitario Central de Asturias /ID# 163053 | Oviedo | Principality of Asturias | 33011 | Spain |
| OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781 | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 141778 | Barcelona | 08035 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 146015 | Barcelona | 08035 | Spain |
| Hospital General de Granollers /ID# 140882 | Barcelona | 08042 | Spain |
| Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572 | Girona | 17007 | Spain |
| Hospital Infantil Universitario Nino Jesus /ID# 165738 | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre /ID# 136998 | Madrid | 28041 | Spain |
| Hospital Universitario La Paz /ID# 161152 | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Malaga /ID# 144289 | Málaga | 29011 | Spain |
| Compl Hospital Univer de Vigo /ID# 136999 | Pontevedra | 36312 | Spain |
| Hospital Universitario Dr. Peset /ID# 159484 | Valencia | 46017 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 141847 | Valencia | 46026 | Spain |
| Karolinska University Hospital Solna /ID# 129045 | Solna | Stockholm County | 171 64 | Sweden |
| Sodersjukhuset /ID# 152685 | Stockholm | Stockholm County | 118 83 | Sweden |
| University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592 | Derby | Derbyshire | DE22 3NE | United Kingdom |
| Sheffield Children's Hospital NHS Foundation Trust /ID# 130370 | Sheffield | England | S10 2TH | United Kingdom |
| Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471 | London | Greater London | E1 2ES | United Kingdom |
| University Hospital Southampton NHS Foundation Trust /ID# 147538 | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Duplicate_NHS Greater Glasgow and Clyde /ID# 127436 | Glasgow | Scotland | G12 0XH | United Kingdom |
| St Helier Hospital /ID# 150097 | Carshalton | Surrey | SM5 1AA | United Kingdom |
| NHS Grampian /ID# 131296 | Aberdeen | AB15 6RE | United Kingdom |
| Birmingham Women's and Children's NHS Foundation Trust /ID# 136631 | Birmingham | B4 6NH | United Kingdom |
| Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779 | Cambridge | CB2 0QQ | United Kingdom |
| Alder Hey Children's Hospital /ID# 138013 | Liverpool | L12 2AP | United Kingdom |
| Manchester University NHS Foundation Trust /ID# 128476 | Manchester | M9 2AA | United Kingdom |
| Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438 | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| St George's University Hospitals NHS Foundation Trust /ID# 131590 | Tooting | SW17 0QT | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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