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NCT02130362 Clinical Trial

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)

Crohn's Disease Clinical Trial

— CAPE  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02130362
Other study ID # P11-292
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 28, 2014
Est. completion date March 2, 2028

Study information
Verified date June 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1446
Est. completion date March 2, 2028
Est. primary completion date March 2, 2028
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Related Conditions & MeSH terms

Locations
Country Name City State
Bosnia and Herzegovina University Clinical Center Tuzla /ID# 130638 Tuzla Tuzlanski
Bulgaria SHAT Hematologic Diseases /ID# 143572 Sofia
Canada Alberta Health Services /ID# 128717 Edmonton Alberta
Canada IWK Health Center /ID# 127912 Halifax Nova Scotia
Canada The Univ of Western Ontario /ID# 137962 London Ontario
Canada Hospital for Sick Children /ID# 127910 Toronto Ontario
Canada Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310 Winnipeg Manitoba
Croatia Zadar General Hospital /ID# 129830 Zadar
Croatia Klinicki bolnicki centar Sestre milosrdnice /ID# 128256 Zagreb Grad Zagreb
Czechia Fakultni nemocnice Hradec Kralove /ID# 128521 Hradec Kralove
Czechia Fakultni nemocnice Olomouc /ID# 127437 Olomouc
Czechia Fakultni Nemocnice Ostrava /ID# 127913 Ostrava
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
Denmark Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013 Hvidovre Hovedstaden
Estonia Tallinn Children's Hospital /ID# 126974 Tallinn
Estonia Children's Clinic Of Tartu Uni /ID# 146017 Tartu
France Duplicate_Hôpital Pierre Wertheimer /ID# 128193 Bron Rhone
France AP-HP - Hopital Necker /ID# 147702 Paris
Germany Universitaetsklinikum Aachen /ID# 126591 Aachen Nordrhein-Westfalen
Germany Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696 Dresden
Germany Duplicate_Universitaetsklinikum Erlangen /ID# 137274 Erlangen Bayern
Germany Froehlich Gemeinschaftspraxis /ID# 127975 Forchheim
Germany Duplicate_Universitaetsklinikum Freiburg /ID# 130010 Freiburg
Germany Kinderarztpraxis Neuhausen /ID# 144402 Munich
Germany Duplicate_Universitaetsklinikum Muenster /ID# 148441 Munster Niedersachsen
Germany Christliches Kinderhospital Osnabrueck /ID# 136629 Osnabrueck
Germany Universitaetsklinikum Regensburg /ID# 137140 Regensburg
Germany Universitaetsklinikum Ulm /ID# 148444 Ulm Baden-Wuerttemberg
Greece Agia Sofia Hospital /ID# 134349 Athens Attiki
Greece General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690 Athens Attiki
Greece Venizeleio General Hospital /ID# 147335 Heraklion
Greece Iatriko Kentro Athinon /ID# 130639 Maroussi Attiki
Greece General Hospital of Thessaloniki Gennimatas /Id# 163658 Thessaloniki
Ireland Our Lady's Hospital /ID# 127438 Manorhamilton Leitrim
Israel Duplicate_Ha'Emek Medical Center /ID# 156316 Afula
Israel Rambam Health Care Campus /ID# 162061 Haifa H_efa
Israel The Lady Davis Carmel Medical Center /ID# 151519 Haifa H_efa
Israel Shaare Zedek Medical Center /ID# 144277 Jerusalem Yerushalayim
Israel Schneider Children's Medical Center /ID# 152683 Petah Tikva HaMerkaz
Israel Edmond And Lily Safra Children /ID# 148730 Ramat Gan Tel-Aviv
Israel Duplicate_Kaplan Medical Center /ID# 152945 Rehovot HaMerkaz
Israel Yitzhak Shamir Medical Center /ID# 157182 Zerifin HaMerkaz
Italy Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347 Bologna
Italy Duplicate_A.O.U. Policlinico G. Martino /ID# 141683 Messina
Italy ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679 Milan
Italy ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279 Milano
Italy Duplicate_Universita di Napoli Federico II /ID# 144280 Naples
Italy A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684 Palermo
Italy Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410 Palermo
Italy Azienda Ospedaliero-Universitaria di Parma /ID# 147441 Parma
Italy Azienda Sanitaria Locale di Pescara /ID# 141307 Pescara
Italy Sapienza University /ID# 141962 Rome Roma
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809 Kaunas
Lithuania Vilnius University Hospital Santaros Klinikos /ID# 127810 Vilnius
Netherlands Duplicate_Academisch Medisch Centrum /ID# 141843 Amsterdam Noord-Holland
Netherlands Duplicate_Erasmus Medisch Centrum /ID# 141841 Rotterdam Zuid-Holland
Portugal 2CA-Braga, Hospital de Braga /ID# 138269 Braga
Portugal Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146 Porto
Puerto Rico Ctr. Gastroenterologia Ped Oes /ID# 140875 Mayaguez
Romania Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358 Bucharest
Romania Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297 Cluj-Napoca Cluj
Romania Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014 Targu Mures
Romania Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251 Timisoara Timis
Spain Complejo Hospitalario Universitario A Coruña /ID# 137235 A Coruña A Coruna
Spain Hospital Universitario Germans Trias i Pujol /ID# 139400 Badalona Barcelona
Spain OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781 Barakaldo Vizcaya
Spain Hospital General de Granollers /ID# 140882 Barcelona
Spain Hospital Universitario Vall d'Hebron /ID# 141778 Barcelona
Spain Hospital Universitario Vall d'Hebron /ID# 146015 Barcelona
Spain Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460 El Palmar Murcia
Spain Hospital Sant Joan de Deu /ID# 152059 Esplugues de Llobregat Barcelona
Spain Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462 Ferrol A Coruna
Spain Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572 Girona
Spain Hospital Universitario Severo Ochoa /ID# 141545 Leganes Madrid
Spain Hospital Infantil Universitario Nino Jesus /ID# 165738 Madrid
Spain Hospital Universitario 12 de Octubre /ID# 136998 Madrid
Spain Hospital Universitario La Paz /ID# 161152 Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872 Majadahonda Madrid
Spain Hospital Regional Universitario de Malaga /ID# 144289 Malaga
Spain Hospital Universitario Central de Asturias /ID# 163053 Oviedo Asturias
Spain Hospital Universitari Son Espases /ID# 147446 Palma de Mallorca Illes Balears
Spain Compl Hospital Univer de Vigo /ID# 136999 Pontevedra
Spain Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029 Sabadell Barcelona
Spain Hospital Clínico Universitario de Santiago-CHUS /ID# 141667 Santiago de Compostela A Coruna
Spain Hospital Universitario Dr. Peset /ID# 159484 Valencia
Spain Hospital Universitario y Politecnico La Fe /ID# 141847 Valencia
Sweden Karolinska University Hospital Solna /ID# 129045 Solna Stockholms Lan
United Kingdom NHS Grampian /ID# 131296 Aberdeen
United Kingdom Birmingham Women's and Children's NHS Foundation Trust /ID# 136631 Birmingham
United Kingdom Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779 Cambridge
United Kingdom St Helier Hospital /ID# 150097 Carshalton Surrey
United Kingdom 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 Barts Health NHS Trust /ID# 128471 London London, City Of
United Kingdom Manchester University NHS Foundation Trust /ID# 128476 Manchester
United Kingdom Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438 Newcastle upon Tyne
United Kingdom Sheffield Children's Hospital NHS Foundation Trust /ID# 130370 Sheffield England
United Kingdom University Hospital Southampton NHS Foundation Trust /ID# 147538 Southampton Hampshire
United Kingdom St George's University Hospitals NHS Foundation Trust /ID# 131590 Tooting
United States Children's Ctr Digestive, US /ID# 144625 Atlanta Georgia
United States Emory Midtown Infectious Disease Clinic /ID# 144274 Atlanta Georgia
United States Children's Hospital Colorado - Aurora /ID# 137261 Aurora Colorado
United States Univ Alabama, Birmingham CCC /ID# 146060 Birmingham Alabama
United States Boston Children's Hospital /ID# 164102 Boston Massachusetts
United States Massachusetts General Hospital /ID# 141552 Boston Massachusetts
United States Tufts Medical Center /ID# 143581 Boston Massachusetts
United States Women and Childrens Hosp /ID# 143778 Buffalo New York
United States University Of Vermont Medical /ID# 137263 Burlington Vermont
United States Univ NC Chapel Hill /ID# 137236 Chapel Hill North Carolina
United States Duplicate_Medical University of South Carolina /ID# 144473 Charleston South Carolina
United States Children's Medical Center /ID# 149256 Dallas Texas
United States Geisinger Medical Center /ID# 149910 Danville Pennsylvania
United States Duke Cancer Center /ID# 137268 Durham North Carolina
United States Pediatric Specialty of VA /ID# 142831 Fairfax Virginia
United States Cook Children's Med. Center /ID# 144474 Fort Worth Texas
United States Connecticut Children's Medical Center - Hartford /ID# 137265 Hartford Connecticut
United States Penn State Child Hosp.Hersh,PA /ID# 144476 Hershey Pennsylvania
United States Texas Children's Hospital /ID# 148211 Houston Texas
United States Univ of Mississippi Med Ctr,US /ID# 137239 Jackson Mississippi
United States Nemours Children's Health System /ID# 148498 Jacksonville Florida
United States Children's Hospital Los Angeles /ID# 141551 Los Angeles California
United States Private practice: Dr. Shervin Rabizadeh /ID# 137269 Los Angeles California
United States University of Miami /ID# 140893 Miami Florida
United States M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238 Minneapolis Minnesota
United States University of South Alabama /ID# 137255 Mobile Alabama
United States Goryeb Children's Hospital /ID# 144275 Morristown New Jersey
United States Yale University School of Medicine /ID# 137257 New Haven Connecticut
United States CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266 New Hyde Park New York
United States Children's Hospital New Orleans /ID# 144477 New Orleans Louisiana
United States Columbia Univ Medical Center /ID# 144440 New York New York
United States Columbia Univ Medical Center /ID# 144475 New York New York
United States Children's Hospital Oklahoma /ID# 144047 Oklahoma City Oklahoma
United States Phoenix Children's Hospital /ID# 141336 Phoenix Arizona
United States Maine Medical Partners /ID# 147685 Portland Maine
United States Mayo Clinic - Rochester /ID# 149245 Rochester Minnesota
United States Rady Children's Hospital San Diego /ID# 140883 San Diego California
United States Univ California, San Francisco /ID# 141312 San Francisco California
United States Seattle Children's Hospital /ID# 140879 Seattle Washington
United States Swedish Medical Center /ID# 137258 Seattle Washington
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 MultiCare Institute for Research & Innovation /ID# 152120 Tacoma Washington
United States Duplicate_UMass Chan Medical School /ID# 148325 Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Lithuania,  Netherlands,  Portugal,  Puerto Rico,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent AESI per 100 PYs of infections and malignancies Up to 10 years
Primary Percentage of subjects with SAEs Up to 10 years
Primary Number of treatment-emergent other AESI per 100 PYs Up to 5 years
Primary Percentage of subjects with other AESI Percentages of subjects with AESIs other than infections and malignancies Up to 5 years
Primary Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies Up to 10 years
Primary Number of subjects with other AESI Number of subjects with AESIs other than infections and malignancies Up to 5 years
Primary Number of treatment-emergent SAEs per 100 patient years (PYs) Up to 10 years
Primary Number of subjects with Serious Adverse Events (SAEs) Up to 10 years
Primary Percentage of subjects with AESI of infections, malignancies, and pregnancies Up to 10 years
Secondary Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) Patient completed questionnaires Up to 5 years
Secondary Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Completed by the patients who are 18 years of age or older Up to 5 years
Secondary 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
Secondary Physician's Global Assessment of Disease Activity (PGA) Completed by the physician Up to 5 years
Secondary IMPACT III Completed by patients ages 10 through 17 years old Up to 5 years
See also
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Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
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Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3

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