NCT02130362Active, not recruiting
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE
Source: ClinicalTrials.gov · Last updated 16 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1446 (actual)
- First submitted
- 1 May 2014
- Start date
- 28 Aug 2014
- Primary completion date
- 30 Nov 2030
- Lead sponsor
- AbbVie
- Diseases
- Crohn's disease
- NCT number
- NCT02130362
What you commit to
- Study type: Observational
- Participants enrolled: 1446
- From 28 Aug 2014 to the primary completion date, 30 Nov 2030
- 148 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures.
- Patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA.
Who the study is looking for
- For a patient enrolling into the HUMIRA treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed Humira therapy according to the routine clinical practice.
- For a patient enrolling into the immunosuppressant therapy treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed azathioprine, 6-mercaptopurine or methotrexate.
- Parent or guardian; or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric CD investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) after the nature of the registry has been explained and the patient, patient's parent or legal guardian has had the opportunity to ask questions.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (148)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SHAT Hematologic Diseases /ID# 143572 Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Alberta Health Services /ID# 128717 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| IWK Health Center /ID# 127912 Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| The Univ of Western Ontario /ID# 137962 Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Hospital for Sick Children /ID# 127910 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310 Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521 Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Fakultni nemocnice Olomouc /ID# 127437 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Fakultni Nemocnice Ostrava /ID# 127913 Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Fakultni nemocnice Kralovske Vinohrady /ID# 127697 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829 Coordinator of this site? Confirm its status | Ústí nad Labem | Czechia | Unknown status |
| Universitaetsklinikum Aachen /ID# 126591 Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Duplicate_Universitaetsklinikum Erlangen /ID# 137274 Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Froehlich Gemeinschaftspraxis /ID# 127975 Coordinator of this site? Confirm its status | Forchheim | Germany | Unknown status |
| Duplicate_Universitaetsklinikum Freiburg /ID# 130010 Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Kinderarztpraxis Neuhausen /ID# 144402 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Duplicate_Universitaetsklinikum Muenster /ID# 148441 Coordinator of this site? Confirm its status | Munster | Germany | Unknown status |
| Christliches Kinderhospital Osnabrueck /ID# 136629 Coordinator of this site? Confirm its status | Osnabrück | Germany | Unknown status |
| Universitaetsklinikum Regensburg /ID# 137140 Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Universitaetsklinikum Ulm /ID# 148444 Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013 Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| Tallinn Children's Hospital /ID# 126974 Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Children's Clinic Of Tartu Uni /ID# 146017 Coordinator of this site? Confirm its status | Tartu | Estonia | Unknown status |
| Complejo Hospitalario Universitario A Coruña /ID# 137235 Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario Germans Trias i Pujol /ID# 139400 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781 Coordinator of this site? Confirm its status | Barakaldo | Spain | Unknown status |
| Hospital Universitario Vall d'Hebron /ID# 141778 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Vall d'Hebron /ID# 146015 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General de Granollers /ID# 140882 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460 Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Sant Joan de Deu /ID# 152059 Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Unknown status |
| Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462 Coordinator of this site? Confirm its status | Ferrol | Spain | Unknown status |
| Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572 Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario Severo Ochoa /ID# 141545 Coordinator of this site? Confirm its status | Leganés | Spain | Unknown status |
| Hospital Universitario La Paz /ID# 161152 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Infantil Universitario Nino Jesus /ID# 165738 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre /ID# 136998 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872 Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Regional Universitario de Malaga /ID# 144289 Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Central de Asturias /ID# 163053 Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitari Son Espases /ID# 147446 Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Compl Hospital Univer de Vigo /ID# 136999 Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029 Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 141667 Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Dr. Peset /ID# 159484 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario y Politecnico La Fe /ID# 141847 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Duplicate_Hôpital Pierre Wertheimer /ID# 128193 Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| AP-HP - Hopital Necker /ID# 147702 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| NHS Grampian /ID# 131296 Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Birmingham Women's and Children's NHS Foundation Trust /ID# 136631 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779 Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| St Helier Hospital /ID# 150097 Coordinator of this site? Confirm its status | Carshalton | United Kingdom | Unknown status |
| University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592 Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Duplicate_NHS Greater Glasgow and Clyde /ID# 127436 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Alder Hey Children's Hospital /ID# 138013 Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust /ID# 128476 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438 Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Sheffield Children's Hospital NHS Foundation Trust /ID# 130370 Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust /ID# 147538 Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| St George's University Hospitals NHS Foundation Trust /ID# 131590 Coordinator of this site? Confirm its status | Tooting | United Kingdom | Unknown status |
| Agia Sofia Hospital /ID# 134349 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Venizeleio General Hospital /ID# 147335 Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| Iatriko Kentro Athinon /ID# 130639 Coordinator of this site? Confirm its status | Marousi | Greece | Unknown status |
| General Hospital of Thessaloniki Gennimatas /Id# 163658 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Zadar General Hospital /ID# 129830 Coordinator of this site? Confirm its status | Zadar | Croatia | Unknown status |
| Klinicki bolnicki centar Sestre milosrdnice /ID# 128256 Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Our Lady's Hospital /ID# 127438 Coordinator of this site? Confirm its status | Manorhamilton | Ireland | Unknown status |
| Duplicate_Ha'Emek Medical Center /ID# 156316 Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Rambam Health Care Campus /ID# 162061 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| The Lady Davis Carmel Medical Center /ID# 151519 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center /ID# 144277 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center /ID# 152683 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Edmond And Lily Safra Children /ID# 148730 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Duplicate_Kaplan Medical Center /ID# 152945 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Yitzhak Shamir Medical Center /ID# 157182 Coordinator of this site? Confirm its status | Tsrifin | Israel | Unknown status |
| Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Duplicate_A.O.U. Policlinico G. Martino /ID# 141683 Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Duplicate_Universita di Napoli Federico II /ID# 144280 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria di Parma /ID# 147441 Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307 Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809 Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
| Vilnius University Hospital Santaros Klinikos /ID# 127810 Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Duplicate_Academisch Medisch Centrum /ID# 141843 Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Duplicate_Erasmus Medisch Centrum /ID# 141841 Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Ctr. Gastroenterologia Ped Oes /ID# 140875 Coordinator of this site? Confirm its status | Mayagüez | Puerto Rico | Unknown status |
| San Jorge Children Hospital /ID# 138067 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| 2CA-Braga, Hospital de Braga /ID# 138269 Coordinator of this site? Confirm its status | Braga | Portugal | Unknown status |
| Unidade Local de Saude Sao Joao, EPE /ID# 138146 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014 Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
| Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251 Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Karolinska University Hospital Solna /ID# 129045 Coordinator of this site? Confirm its status | Solna | Sweden | Unknown status |
| Sodersjukhuset /ID# 152685 Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Children's Ctr Digestive, US /ID# 144625 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Winship Cancer Institute of Emory University /ID# 144274 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado - Aurora /ID# 137261 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Univ Alabama, Birmingham CCC /ID# 146060 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Tufts Medical Center /ID# 143581 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston Children's Hospital /ID# 164102 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital /ID# 141552 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Women and Childrens Hosp /ID# 143778 Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University Of Vermont Medical /ID# 137263 Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Univ NC Chapel Hill /ID# 137236 Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Duplicate_Medical University of South Carolina /ID# 144473 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Children's Medical Center /ID# 149256 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Geisinger Medical Center /ID# 149910 Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Duke Cancer Center /ID# 137268 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Pediatric Specialty of VA /ID# 142831 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Cook Children's Med. Center /ID# 144474 Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Connecticut Children's Medical Center - Hartford /ID# 137265 Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Penn State Child Hosp.Hersh,PA /ID# 144476 Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Texas Children's Hospital /ID# 148211 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Univ of Mississippi Med Ctr,US /ID# 137239 Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Health System /ID# 148498 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Private practice: Dr. Shervin Rabizadeh /ID# 137269 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital Los Angeles /ID# 141551 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami /ID# 140893 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| University of South Alabama /ID# 137255 Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Goryeb Children's Hospital /ID# 144275 Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Yale University School of Medicine /ID# 137257 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266 Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Children's Hospital New Orleans /ID# 144477 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Columbia Univ Medical Center /ID# 144440 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia Univ Medical Center /ID# 144475 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital Oklahoma /ID# 144047 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Phoenix Children's Hospital /ID# 141336 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Maine Medical Partners /ID# 147685 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Mayo Clinic - Rochester /ID# 149245 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Rady Children's Hospital San Diego /ID# 140883 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Univ California, San Francisco /ID# 141312 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Seattle Children's Hospital /ID# 140879 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Duplicate_Swedish Medical Center /ID# 137258 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Univ Med Ctr at Stony Brook /ID# 140913 Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| SUNY Upstate Medical University /ID# 148437 Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| MultiCare Institute for Research & Innovation /ID# 152120 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Duplicate_UMass Chan Medical School /ID# 148325 Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| University Clinical Center Tuzla /ID# 130638 Coordinator of this site? Confirm its status | Tuzla | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.