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) (CAPE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn's Disease

• Study Type: Observational
• Enrollment (Actual): 1446

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Tuzlanski
    • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
      • University Clinical Center Tuzla /ID# 130638
• Bulgaria
  • Sofia, Bulgaria, 1756
    • SHAT Hematologic Diseases /ID# 143572
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C9
      • Alberta Health Services /ID# 128717
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 141310
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Center /ID# 127912
  • Ontario
    • London, Ontario, Canada, N6A 5K8
      • The Univ of Western Ontario /ID# 137962
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children /ID# 127910
• Croatia
  • Zadar, Croatia, 23000
    • Zadar General Hospital /ID# 129830
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Sestre milosrdnice /ID# 128256
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove /ID# 128521
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc /ID# 127437
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava /ID# 127913
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady /ID# 127697
  • Usti Nad Labem, Czechia, 401 13
    • Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829
• Denmark
  • Hovedstaden
    • Hvidovre, Hovedstaden, Denmark, 2650
      • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013
• Estonia
  • Tallinn, Estonia, 13419
    • Tallinn Children's Hospital /ID# 126974
  • Tartu, Estonia, 51014
    • Children's Clinic Of Tartu Uni /ID# 146017
• France
  • Bron, France, 69677
    • Hôpital Pierre Wertheimer /ID# 128193
  • Paris, France, 75015
    • AP-HP - Hopital Necker /ID# 147702
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696
  • Forchheim, Germany, 91301
    • Froehlich Gemeinschaftspraxis /ID# 127975
  • Freiburg, Germany, 79106
    • Duplicate_Universitaetsklinikum Freiburg /ID# 130010
  • Munich, Germany, 80634
    • Kinderarztpraxis Neuhausen /ID# 144402
  • Osnabrueck, Germany, 49074
    • Christliches Kinderhospital Osnabrueck /ID# 136629
  • Regensburg, Germany, 93042
    • Universitaetsklinikum Regensburg /ID# 137140
  • Baden-Wuerttemberg
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 148444
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 137274
  • Niedersachsen
    • Munster, Niedersachsen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 148441
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Universitaetsklinikum Aachen /ID# 126591
• Greece
  • Heraklion, Greece, 71409
    • Venizeleio General Hospital /ID# 147335
  • Thessaloniki, Greece, 54635
    • General Hospital of Thessaloniki Gennimatas /Id# 163658
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Agia Sofia Hospital /ID# 134349
    • Athens, Attiki, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690
    • Marousi, Attiki, Greece, 15125
      • Iatriko Kentro Athinon /ID# 130639
• Ireland
  • Leitrim
    • Manorhamilton, Leitrim, Ireland
      • Our Lady's Hospital /ID# 127438
• Israel
  • Afula, Israel, 18341
    • Duplicate_Ha'Emek Medical Center /ID# 156316
  • Be'Er Ya'Akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 157182
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 162061
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center /ID# 151519
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 144277
  • Petah Tikva, Israel, 4920235
    • Schneider Children's Medical Center /ID# 152683
  • Ramat Gan, Israel, 5262100
    • Edmond And Lily Safra Children /ID# 148730
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center /ID# 152945
• Italy
  • Bologna, Italy, 40133
    • Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347
  • Messina, Italy, 98125
    • A.O.U. Policlinico G. Martino /ID# 141683
  • Milan, Italy, 20154
    • ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679
  • Milano, Italy, 20121
    • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279
  • Naples, Italy, 80131
    • Duplicate_Universita di Napoli Federico II /ID# 144280
  • Palermo, Italy, 90146
    • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma /ID# 147441
  • Pescara, Italy, 65124
    • Azienda Sanitaria Locale di Pescara /ID# 141307
  • Lazio
    • Rome, Lazio, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos /ID# 127810
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum /ID# 141843
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum /ID# 141841
• Portugal
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 138269
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146
• Puerto Rico
  • Mayaguez, Puerto Rico, 00680
    • Ctr. Gastroenterologia Ped Oes /ID# 140875
• Romania
  • Bucharest, Romania, 011743
    • Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358
  • Targu Mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400177
      • Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297
  • Timis
    • Timisoara, Timis, Romania, 500063
      • Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 137235
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 141778
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 146015
  • Barcelona, Spain, 08042
    • Hospital General de Granollers /ID# 140882
  • Girona, Spain, 17007
    • Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus /ID# 165738
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 136998
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 161152
  • Malaga, Spain, 29011
    • Hospital Regional Universitario de Malaga /ID# 144289
  • Pontevedra, Spain, 36312
    • Compl Hospital Univer de Vigo /ID# 136999
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset /ID# 159484
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 141847
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clínico Universitario de Santiago-CHUS /ID# 141667
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias /ID# 163053
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 139400
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu /ID# 152059
    • Sabadell, Barcelona, Spain, 08208
      • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07120
      • Hospital Universitari Son Espases /ID# 147446
  • Madrid
    • Leganes, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa /ID# 141545
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157872
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781
• Sweden
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 129045
• United Kingdom
  • Aberdeen, United Kingdom, AB15 6RE
    • NHS Grampian /ID# 131296
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Women's and Children's NHS Foundation Trust /ID# 136631
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust /ID# 143779
  • Liverpool, United Kingdom, L12 2AP
    • Alder Hey Children's NHS Foundation Trust /ID# 138013
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's NHS Foundation Trust /ID# 130370
  • Tooting, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust /ID# 131590
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 147538
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M13 9WL
      • Manchester University NHS Foundation Trust /ID# 128476
  • London, City Of
    • London, London, City Of, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 128471
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 127436
  • Surrey
    • Carshalton, Surrey, United Kingdom, SM5 1AA
      • Epsom & St Helier University Hospital NHS Trust /ID# 150097
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • Univ Alabama, Birmingham CCC /ID# 146060
    • Mobile, Alabama, United States, 36617
      • University of South Alabama /ID# 137255
  • Arizona
    • Phoenix, Arizona, United States, 85016-7710
      • Phoenix Children's Hospital /ID# 141336
  • California
    • Los Angeles, California, United States, 90048
      • Private practice: Dr. Shervin Rabizadeh /ID# 137269
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles /ID# 141551
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego /ID# 140883
    • San Francisco, California, United States, 94143-2204
      • Univ California, San Francisco /ID# 141312
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado /ID# 137261
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center - Hartford /ID# 137265
    • New Haven, Connecticut, United States, 06510
      • Yale University /ID# 137257
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Health System /ID# 148498
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 140893
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Midtown Infectious Disease Clinic /ID# 144274
    • Atlanta, Georgia, United States, 30342
      • Children's Ctr Digestive, US /ID# 144625
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital New Orleans /ID# 144477
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Partners /ID# 147685
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 143581
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 141552
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital /ID# 164102
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School /ID# 148325
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455-0356
      • University of Minnesota /ID# 137238
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4643
      • Univ of Mississippi Med Ctr,US /ID# 137239
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Goryeb Children's Hospital /ID# 144275
  • New York
    • Buffalo, New York, United States, 14222
      • Women and Childrens Hosp /ID# 143778
    • New Hyde Park, New York, United States, 11042-2057
      • CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266
    • New York, New York, United States, 10032-3725
      • Columbia Univ Medical Center /ID# 144440
    • New York, New York, United States, 10032-3725
      • Columbia Univ Medical Center /ID# 144475
    • Stony Brook, New York, United States, 11794
      • Univ Med Ctr at Stony Brook /ID# 140913
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University /ID# 148437
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 137236
    • Durham, North Carolina, United States, 27710-3000
      • Duke Cancer Center /ID# 137268
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Children's Hospital Oklahoma /ID# 144047
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center /ID# 149910
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Child Hosp.Hersh,PA /ID# 144476
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 144473
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center /ID# 149256
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Med. Center /ID# 144474
    • Houston, Texas, United States, 77030-2608
      • Texas Children's Hospital /ID# 148211
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University Of Vermont Medical /ID# 137263
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Pediatric Specialty of VA /ID# 142831
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center /ID# 137258
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital /ID# 140879
    • Tacoma, Washington, United States, 98405
      • Multicare Institute for Research and Innovation /ID# 152120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2014
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): March 2, 2028

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimated): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gastrointestinal Diseases; Registry; Crohn's Disease; Inflammatory Bowel Diseases; Adalimumab; Crohn's
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: P11-292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No