Clinical trial NCT02130362: 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)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Registry
Adalimumab
Crohn's
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 1446
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

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