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)
- Conditions
- Crohn's Disease
- Registration Number
- NCT02130362
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1446
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of treatment-emergent other AESI per 100 PYs Up to 5 years Number of treatment-emergent AESI per 100 PYs of infections and malignancies Up to 10 years Number of treatment-emergent SAEs per 100 patient years (PYs) Up to 10 years Percentage of subjects with AESI of infections, malignancies, and pregnancies Up to 10 years Percentage of subjects with SAEs Up to 10 years Number of subjects with other AESI Up to 5 years Number of subjects with AESIs other than infections and malignancies
Percentage of subjects with other AESI Up to 5 years Percentages of subjects with AESIs other than infections and malignancies
Number of subjects with Serious Adverse Events (SAEs) Up to 10 years Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies Up to 10 years
- Secondary Outcome Measures
Name Time Method Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) Up to 5 years Patient completed questionnaires
IMPACT III Up to 5 years Completed by patients ages 10 through 17 years old
Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Up to 5 years Completed by the patients who are 18 years of age or older
Work Productivity and Activity Impairment (WPAI) questionnaire Up to 5 years Completed by caregiver up to the age of 17 years and completed by the patients of age 18 years or above.
Physician's Global Assessment of Disease Activity (PGA) Up to 5 years Completed by the physician
Trial Locations
- Locations (145)
Massachusetts General Hospital /ID# 141552
🇺🇸Boston, Massachusetts, United States
Rady Children's Hospital San Diego /ID# 140883
🇺🇸San Diego, California, United States
General Hospital of Thessaloniki Gennimatas /Id# 163658
🇬🇷Thessaloniki, Greece
The Lady Davis Carmel Medical Center /ID# 151519
🇮🇱Haifa, H_efa, Israel
Our Lady's Hospital /ID# 127438
🇮🇪Manorhamilton, Leitrim, Ireland
Schneider Children's Medical Center /ID# 152683
🇮🇱Petah Tikva, HaMerkaz, Israel
Duplicate_Kaplan Medical Center /ID# 152945
🇮🇱Rehovot, HaMerkaz, Israel
Yitzhak Shamir Medical Center /ID# 157182
🇮🇱Zerifin, HaMerkaz, Israel
University of South Alabama /ID# 137255
🇺🇸Mobile, Alabama, United States
Private practice: Dr. Shervin Rabizadeh /ID# 137269
🇺🇸Los Angeles, California, United States
Children's Hospital Los Angeles /ID# 141551
🇺🇸Los Angeles, California, United States
Connecticut Children's Medical Center - Hartford /ID# 137265
🇺🇸Hartford, Connecticut, United States
Nemours Children's Health System /ID# 148498
🇺🇸Jacksonville, Florida, United States
University of Miami /ID# 140893
🇺🇸Miami, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 144274
🇺🇸Atlanta, Georgia, United States
Children's Ctr Digestive, US /ID# 144625
🇺🇸Atlanta, Georgia, United States
Maine Medical Partners /ID# 147685
🇺🇸Portland, Maine, United States
Tufts Medical Center /ID# 143581
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital /ID# 164102
🇺🇸Boston, Massachusetts, United States
Goryeb Children's Hospital /ID# 144275
🇺🇸Morristown, New Jersey, United States
Duplicate_UMass Chan Medical School /ID# 148325
🇺🇸Worcester, Massachusetts, United States
Women and Childrens Hosp /ID# 143778
🇺🇸Buffalo, New York, United States
Univ of Mississippi Med Ctr,US /ID# 137239
🇺🇸Jackson, Mississippi, United States
CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266
🇺🇸New Hyde Park, New York, United States
Columbia Univ Medical Center /ID# 144475
🇺🇸New York, New York, United States
Univ Med Ctr at Stony Brook /ID# 140913
🇺🇸Stony Brook, New York, United States
SUNY Upstate Medical University /ID# 148437
🇺🇸Syracuse, New York, United States
Geisinger Medical Center /ID# 149910
🇺🇸Danville, Pennsylvania, United States
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238
🇺🇸Minneapolis, Minnesota, United States
Duke Cancer Center /ID# 137268
🇺🇸Durham, North Carolina, United States
Penn State Child Hosp.Hersh,PA /ID# 144476
🇺🇸Hershey, Pennsylvania, United States
Children's Medical Center /ID# 149256
🇺🇸Dallas, Texas, United States
Cook Children's Med. Center /ID# 144474
🇺🇸Fort Worth, Texas, United States
University Of Vermont Medical /ID# 137263
🇺🇸Burlington, Vermont, United States
Texas Children's Hospital /ID# 148211
🇺🇸Houston, Texas, United States
Seattle Children's Hospital /ID# 140879
🇺🇸Seattle, Washington, United States
Pediatric Specialty of VA /ID# 142831
🇺🇸Fairfax, Virginia, United States
Swedish Medical Center /ID# 137258
🇺🇸Seattle, Washington, United States
Alberta Health Services /ID# 128717
🇨🇦Edmonton, Alberta, Canada
SHAT Hematologic Diseases /ID# 143572
🇧🇬Sofia, Bulgaria
MultiCare Institute for Research & Innovation /ID# 152120
🇺🇸Tacoma, Washington, United States
Hospital for Sick Children /ID# 127910
🇨🇦Toronto, Ontario, Canada
The Univ of Western Ontario /ID# 137962
🇨🇦London, Ontario, Canada
Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310
🇨🇦Winnipeg, Manitoba, Canada
IWK Health Center /ID# 127912
🇨🇦Halifax, Nova Scotia, Canada
Zadar General Hospital /ID# 129830
ðŸ‡ðŸ‡·Zadar, Croatia
Fakultni nemocnice Hradec Kralove /ID# 128521
🇨🇿Hradec Kralove, Czechia
Klinicki bolnicki centar Sestre milosrdnice /ID# 128256
ðŸ‡ðŸ‡·Zagreb, Grad Zagreb, Croatia
Fakultni Nemocnice Ostrava /ID# 127913
🇨🇿Ostrava, Czechia
Fakultni nemocnice Olomouc /ID# 127437
🇨🇿Olomouc, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 127697
🇨🇿Praha, Czechia
Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829
🇨🇿Usti Nad Labem, Czechia
AP-HP - Hopital Necker /ID# 147702
🇫🇷Paris, France
Duplicate_Hôpital Pierre Wertheimer /ID# 128193
🇫🇷Bron, Rhone, France
Children's Clinic Of Tartu Uni /ID# 146017
🇪🇪Tartu, Estonia
Rambam Health Care Campus /ID# 162061
🇮🇱Haifa, H_efa, Israel
Universitaetsklinikum Ulm /ID# 148444
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Aachen /ID# 126591
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Duplicate_Universitaetsklinikum Erlangen /ID# 137274
🇩🇪Erlangen, Bayern, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696
🇩🇪Dresden, Germany
Christliches Kinderhospital Osnabrueck /ID# 136629
🇩🇪Osnabrueck, Germany
Duplicate_Universitaetsklinikum Muenster /ID# 148441
🇩🇪Munster, Niedersachsen, Germany
Froehlich Gemeinschaftspraxis /ID# 127975
🇩🇪Forchheim, Germany
Kinderarztpraxis Neuhausen /ID# 144402
🇩🇪Munich, Germany
Duplicate_Universitaetsklinikum Freiburg /ID# 130010
🇩🇪Freiburg, Germany
Universitaetsklinikum Regensburg /ID# 137140
🇩🇪Regensburg, Germany
Agia Sofia Hospital /ID# 134349
🇬🇷Athens, Attiki, Greece
Venizeleio General Hospital /ID# 147335
🇬🇷Heraklion, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690
🇬🇷Athens, Attiki, Greece
Iatriko Kentro Athinon /ID# 130639
🇬🇷Maroussi, Attiki, Greece
Duplicate_Ha'Emek Medical Center /ID# 156316
🇮🇱Afula, Israel
Edmond And Lily Safra Children /ID# 148730
🇮🇱Ramat Gan, Tel-Aviv, Israel
Sapienza University /ID# 141962
🇮🇹Rome, Roma, Italy
Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347
🇮🇹Bologna, Italy
Shaare Zedek Medical Center /ID# 144277
🇮🇱Jerusalem, Yerushalayim, Israel
Duplicate_A.O.U. Policlinico G. Martino /ID# 141683
🇮🇹Messina, Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279
🇮🇹Milano, Italy
Duplicate_Universita di Napoli Federico II /ID# 144280
🇮🇹Naples, Italy
ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679
🇮🇹Milan, Italy
Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410
🇮🇹Palermo, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684
🇮🇹Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma /ID# 147441
🇮🇹Parma, Italy
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809
🇱🇹Kaunas, Lithuania
Azienda Sanitaria Locale di Pescara /ID# 141307
🇮🇹Pescara, Italy
Duplicate_Academisch Medisch Centrum /ID# 141843
🇳🇱Amsterdam, Noord-Holland, Netherlands
Vilnius University Hospital Santaros Klinikos /ID# 127810
🇱🇹Vilnius, Lithuania
Duplicate_Erasmus Medisch Centrum /ID# 141841
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146
🇵🇹Porto, Portugal
Ctr. Gastroenterologia Ped Oes /ID# 140875
🇵🇷Mayaguez, Puerto Rico
Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297
🇷🇴Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358
🇷🇴Bucharest, Romania
Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251
🇷🇴Timisoara, Timis, Romania
Complejo Hospitalario Universitario A Coruña /ID# 137235
🇪🇸A Coruña, A Coruna, Spain
Hospital Universitario Vall d'Hebron /ID# 141778
🇪🇸Barcelona, Spain
Hospital ClÃnico Universitario de Santiago-CHUS /ID# 141667
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital Sant Joan de Deu /ID# 152059
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Germans Trias i Pujol /ID# 139400
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Severo Ochoa /ID# 141545
🇪🇸Leganes, Madrid, Spain
Hospital Universitari Son Espases /ID# 147446
🇪🇸Palma de Mallorca, Illes Balears, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029
🇪🇸Sabadell, Barcelona, Spain
OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781
🇪🇸Barakaldo, Vizcaya, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460
🇪🇸El Palmar, Murcia, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872
🇪🇸Majadahonda, Madrid, Spain
Hospital General de Granollers /ID# 140882
🇪🇸Barcelona, Spain
Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572
🇪🇸Girona, Spain
Hospital Universitario Vall d'Hebron /ID# 146015
🇪🇸Barcelona, Spain
Hospital Infantil Universitario Nino Jesus /ID# 165738
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 161152
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 136998
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga /ID# 144289
🇪🇸Malaga, Spain
Compl Hospital Univer de Vigo /ID# 136999
🇪🇸Pontevedra, Spain
Hospital Universitario Dr. Peset /ID# 159484
🇪🇸Valencia, Spain
Hospital Universitario y Politecnico La Fe /ID# 141847
🇪🇸Valencia, Spain
Karolinska University Hospital Solna /ID# 129045
🇸🇪Solna, Stockholms Lan, Sweden
University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592
🇬🇧Derby, Derbyshire, United Kingdom
NHS Greater Glasgow and Clyde /ID# 127436
🇬🇧Glasgow, Scotland, United Kingdom
Alder Hey Children's Hospital /ID# 138013
🇬🇧Liverpool, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 136631
🇬🇧Birmingham, United Kingdom
St Helier Hospital /ID# 150097
🇬🇧Carshalton, Surrey, United Kingdom
Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779
🇬🇧Cambridge, United Kingdom
NHS Grampian /ID# 131296
🇬🇧Aberdeen, United Kingdom
Manchester University NHS Foundation Trust /ID# 128476
🇬🇧Manchester, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 131590
🇬🇧Tooting, United Kingdom
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438
🇬🇧Newcastle upon Tyne, United Kingdom
University Clinical Center Tuzla /ID# 130638
🇧🇦Tuzla, Tuzlanski, Bosnia and Herzegovina
Hospital Universitario Central de Asturias /ID# 163053
🇪🇸Oviedo, Asturias, Spain
Tallinn Children's Hospital /ID# 126974
🇪🇪Tallinn, Estonia
2CA-Braga, Hospital de Braga /ID# 138269
🇵🇹Braga, Portugal
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014
🇷🇴Targu Mures, Romania
University Hospital Southampton NHS Foundation Trust /ID# 147538
🇬🇧Southampton, Hampshire, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust /ID# 130370
🇬🇧Sheffield, England, United Kingdom
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013
🇩🇰Hvidovre, Hovedstaden, Denmark
Barts Health NHS Trust /ID# 128471
🇬🇧London, London, City Of, United Kingdom
Univ Alabama, Birmingham CCC /ID# 146060
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital /ID# 141336
🇺🇸Phoenix, Arizona, United States
Univ California, San Francisco /ID# 141312
🇺🇸San Francisco, California, United States
Mayo Clinic - Rochester /ID# 149245
🇺🇸Rochester, Minnesota, United States
Children's Hospital Oklahoma /ID# 144047
🇺🇸Oklahoma City, Oklahoma, United States
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462
🇪🇸Ferrol, A Coruna, Spain
Columbia Univ Medical Center /ID# 144440
🇺🇸New York, New York, United States
Children's Hospital Colorado - Aurora /ID# 137261
🇺🇸Aurora, Colorado, United States
Children's Hospital New Orleans /ID# 144477
🇺🇸New Orleans, Louisiana, United States
Yale University School of Medicine /ID# 137257
🇺🇸New Haven, Connecticut, United States
Duplicate_Medical University of South Carolina /ID# 144473
🇺🇸Charleston, South Carolina, United States
Univ NC Chapel Hill /ID# 137236
🇺🇸Chapel Hill, North Carolina, United States