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
1 other identifier
observational
1,446
21 countries
125
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 5, 2014
CompletedStudy Start
First participant enrolled
August 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
July 16, 2025
July 1, 2025
16.2 years
May 1, 2014
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (5)
Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)
Up to 5 years
Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)
Up to 5 years
Work Productivity and Activity Impairment (WPAI) questionnaire
Up to 5 years
Physician's Global Assessment of Disease Activity (PGA)
Up to 5 years
IMPACT III
Up to 5 years
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (148)
Univ Alabama, Birmingham CCC /ID# 146060
Birmingham, Alabama, 35294-3300, United States
University of South Alabama /ID# 137255
Mobile, Alabama, 36617, United States
Phoenix Children's Hospital /ID# 141336
Phoenix, Arizona, 85016-7710, United States
Children's Hospital Los Angeles /ID# 141551
Los Angeles, California, 90027, United States
Private practice: Dr. Shervin Rabizadeh /ID# 137269
Los Angeles, California, 90048, United States
Rady Children's Hospital San Diego /ID# 140883
San Diego, California, 92123, United States
Univ California, San Francisco /ID# 141312
San Francisco, California, 94143-2204, United States
Children's Hospital Colorado - Aurora /ID# 137261
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center - Hartford /ID# 137265
Hartford, Connecticut, 06106, United States
Yale University School of Medicine /ID# 137257
New Haven, Connecticut, 06510, United States
Nemours Children's Health System /ID# 148498
Jacksonville, Florida, 32207, United States
University of Miami /ID# 140893
Miami, Florida, 33136, United States
Winship Cancer Institute of Emory University /ID# 144274
Atlanta, Georgia, 30322, United States
Children's Ctr Digestive, US /ID# 144625
Atlanta, Georgia, 30342, United States
Children's Hospital New Orleans /ID# 144477
New Orleans, Louisiana, 70118, United States
Maine Medical Partners /ID# 147685
Portland, Maine, 04102, United States
Tufts Medical Center /ID# 143581
Boston, Massachusetts, 02111-1552, United States
Massachusetts General Hospital /ID# 141552
Boston, Massachusetts, 02114, United States
Boston Children's Hospital /ID# 164102
Boston, Massachusetts, 02115, United States
Duplicate_UMass Chan Medical School /ID# 148325
Worcester, Massachusetts, 01655, United States
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester /ID# 149245
Rochester, Minnesota, 55905-0001, United States
Univ of Mississippi Med Ctr,US /ID# 137239
Jackson, Mississippi, 39216-4643, United States
Goryeb Children's Hospital /ID# 144275
Morristown, New Jersey, 07960, United States
Women and Childrens Hosp /ID# 143778
Buffalo, New York, 14222, United States
CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266
New Hyde Park, New York, 11042-2057, United States
Columbia Univ Medical Center /ID# 144440
New York, New York, 10032-3725, United States
Columbia Univ Medical Center /ID# 144475
New York, New York, 10032-3725, United States
Univ Med Ctr at Stony Brook /ID# 140913
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University /ID# 148437
Syracuse, New York, 13210, United States
Univ NC Chapel Hill /ID# 137236
Chapel Hill, North Carolina, 27514-4220, United States
Duke Cancer Center /ID# 137268
Durham, North Carolina, 27710-3000, United States
Children's Hospital Oklahoma /ID# 144047
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center /ID# 149910
Danville, Pennsylvania, 17822, United States
Penn State Child Hosp.Hersh,PA /ID# 144476
Hershey, Pennsylvania, 17033, United States
Duplicate_Medical University of South Carolina /ID# 144473
Charleston, South Carolina, 29425, United States
Children's Medical Center /ID# 149256
Dallas, Texas, 75235, United States
Cook Children's Med. Center /ID# 144474
Fort Worth, Texas, 76104, United States
Texas Children's Hospital /ID# 148211
Houston, Texas, 77030-2608, United States
University Of Vermont Medical /ID# 137263
Burlington, Vermont, 05405, United States
Pediatric Specialty of VA /ID# 142831
Fairfax, Virginia, 22031, United States
Duplicate_Swedish Medical Center /ID# 137258
Seattle, Washington, 98104, United States
Seattle Children's Hospital /ID# 140879
Seattle, Washington, 98105, United States
MultiCare Institute for Research & Innovation /ID# 152120
Tacoma, Washington, 98405, United States
Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259
Milwaukee, Wisconsin, 53226, United States
University Clinical Center Tuzla /ID# 130638
Tuzla, Tuzlanski, 75000, Bosnia and Herzegovina
SHAT Hematologic Diseases /ID# 143572
Sofia, 1797, Bulgaria
Alberta Health Services /ID# 128717
Edmonton, Alberta, T6G 1C9, Canada
Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310
Winnipeg, Manitoba, R3E 3P4, Canada
IWK Health Center /ID# 127912
Halifax, Nova Scotia, B3K 6R8, Canada
The Univ of Western Ontario /ID# 137962
London, Ontario, N6A 5K8, Canada
Hospital for Sick Children /ID# 127910
Toronto, Ontario, M5G 1X8, Canada
Klinicki bolnicki centar Sestre milosrdnice /ID# 128256
Zagreb, City of Zagreb, 10000, Croatia
Zadar General Hospital /ID# 129830
Zadar, 23000, Croatia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521
Hradec Králové, Hradec Kralove, 500 05, Czechia
Fakultni Nemocnice Ostrava /ID# 127913
Ostrava, Ostrava-mesto, 708 52, Czechia
Fakultni nemocnice Olomouc /ID# 127437
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 127697
Prague, 100 34, Czechia
Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829
Ústí nad Labem, 401 13, Czechia
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013
Hvidovre, Capital Region, 2650, Denmark
Tallinn Children's Hospital /ID# 126974
Tallinn, Harju, 13419, Estonia
Children's Clinic Of Tartu Uni /ID# 146017
Tartu, Tartu, 51014, Estonia
Duplicate_Hôpital Pierre Wertheimer /ID# 128193
Bron, Rhone, 69677, France
AP-HP - Hopital Necker /ID# 147702
Paris, 75015, France
Universitaetsklinikum Ulm /ID# 148444
Ulm, Baden-Wurttemberg, 89081, Germany
Duplicate_Universitaetsklinikum Erlangen /ID# 137274
Erlangen, Bavaria, 91054, Germany
Duplicate_Universitaetsklinikum Muenster /ID# 148441
Munster, Lower Saxony, 48149, Germany
Christliches Kinderhospital Osnabrueck /ID# 136629
Osnabrück, Lower Saxony, 49074, Germany
Universitaetsklinikum Aachen /ID# 126591
Aachen, North Rhine-Westphalia, 52074, Germany
Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696
Dresden, Saxony, 01307, Germany
Froehlich Gemeinschaftspraxis /ID# 127975
Forchheim, 91301, Germany
Duplicate_Universitaetsklinikum Freiburg /ID# 130010
Freiburg im Breisgau, 79106, Germany
Kinderarztpraxis Neuhausen /ID# 144402
Munich, 80634, Germany
Universitaetsklinikum Regensburg /ID# 137140
Regensburg, 93042, Germany
Agia Sofia Hospital /ID# 134349
Athens, Attica, 11527, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690
Athens, Attica, 11527, Greece
Iatriko Kentro Athinon /ID# 130639
Marousi, Attica, 15125, Greece
Venizeleio General Hospital /ID# 147335
Heraklion, 71409, Greece
General Hospital of Thessaloniki Gennimatas /Id# 163658
Thessaloniki, 54635, Greece
Our Lady's Hospital /ID# 127438
Manorhamilton, Leitrim, Ireland
Schneider Children's Medical Center /ID# 152683
Petah Tikva, Central District, 4920235, Israel
Duplicate_Kaplan Medical Center /ID# 152945
Rehovot, Central District, 7661041, Israel
Yitzhak Shamir Medical Center /ID# 157182
Ẕerifin, Central District, 70300, Israel
Shaare Zedek Medical Center /ID# 144277
Jerusalem, Jerusalem, 91031, Israel
Edmond And Lily Safra Children /ID# 148730
Ramat Gan, Tel Aviv, 5262100, Israel
Duplicate_Ha'Emek Medical Center /ID# 156316
Afula, 18341, Israel
Rambam Health Care Campus /ID# 162061
Haifa, 3109601, Israel
The Lady Davis Carmel Medical Center /ID# 151519
Haifa, 34362, Israel
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279
Milan, Milano, 20122, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962
Rome, Roma, 00161, Italy
Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347
Bologna, 40133, Italy
Duplicate_A.O.U. Policlinico G. Martino /ID# 141683
Messina, 98125, Italy
ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679
Milan, 20154, Italy
Duplicate_Universita di Napoli Federico II /ID# 144280
Naples, 80131, Italy
Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410
Palermo, 90127, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684
Palermo, 90146, Italy
Azienda Ospedaliero-Universitaria di Parma /ID# 147441
Parma, 43126, Italy
Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307
Pescara, 65124, Italy
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809
Kaunas, 50161, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 127810
Vilnius, 08661, Lithuania
Duplicate_Academisch Medisch Centrum /ID# 141843
Amsterdam, North Holland, 1105 AZ, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 141841
Rotterdam, South Holland, 3015 GD, Netherlands
2CA-Braga, Hospital de Braga /ID# 138269
Braga, 4710-243, Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 138146
Porto, 4200-319, Portugal
Ctr. Gastroenterologia Ped Oes /ID# 140875
Mayagüez, 00680, Puerto Rico
San Jorge Children Hospital /ID# 138067
San Juan, 00912-3310, Puerto Rico
Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297
Cluj-Napoca, Cluj, 400177, Romania
Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251
Timișoara, Timiș County, 500063, Romania
Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358
Bucharest, 011743, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014
Târgu Mureş, 540136, Romania
Complejo Hospitalario Universitario A Coruña /ID# 137235
A Coruña, A Coruna, 15006, Spain
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462
Ferrol, A Coruna, 15405, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 141667
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari Son Espases /ID# 147446
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Germans Trias i Pujol /ID# 139400
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan de Deu /ID# 152059
Esplugues de Llobregat, Barcelona, 08950, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Severo Ochoa /ID# 141545
Leganés, Madrid, 28911, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872
Majadahonda, Madrid, 28222, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460
El Palmar, Murcia, 30120, Spain
Hospital Universitario Central de Asturias /ID# 163053
Oviedo, Principality of Asturias, 33011, Spain
OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario Vall d'Hebron /ID# 141778
Barcelona, 08035, Spain
Hospital Universitario Vall d'Hebron /ID# 146015
Barcelona, 08035, Spain
Hospital General de Granollers /ID# 140882
Barcelona, 08042, Spain
Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572
Girona, 17007, Spain
Hospital Infantil Universitario Nino Jesus /ID# 165738
Madrid, 28009, Spain
Hospital Universitario 12 de Octubre /ID# 136998
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 161152
Madrid, 28046, Spain
Hospital Regional Universitario de Malaga /ID# 144289
Málaga, 29011, Spain
Compl Hospital Univer de Vigo /ID# 136999
Pontevedra, 36312, Spain
Hospital Universitario Dr. Peset /ID# 159484
Valencia, 46017, Spain
Hospital Universitario y Politecnico La Fe /ID# 141847
Valencia, 46026, Spain
Karolinska University Hospital Solna /ID# 129045
Solna, Stockholm County, 171 64, Sweden
Sodersjukhuset /ID# 152685
Stockholm, Stockholm County, 118 83, Sweden
University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592
Derby, Derbyshire, DE22 3NE, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust /ID# 130370
Sheffield, England, S10 2TH, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471
London, Greater London, E1 2ES, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 147538
Southampton, Hampshire, SO16 6YD, United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 127436
Glasgow, Scotland, G12 0XH, United Kingdom
St Helier Hospital /ID# 150097
Carshalton, Surrey, SM5 1AA, United Kingdom
NHS Grampian /ID# 131296
Aberdeen, AB15 6RE, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 136631
Birmingham, B4 6NH, United Kingdom
Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779
Cambridge, CB2 0QQ, United Kingdom
Alder Hey Children's Hospital /ID# 138013
Liverpool, L12 2AP, United Kingdom
Manchester University NHS Foundation Trust /ID# 128476
Manchester, M9 2AA, United Kingdom
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438
Newcastle upon Tyne, NE7 7DN, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 131590
Tooting, SW17 0QT, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 5, 2014
Study Start
August 28, 2014
Primary Completion (Estimated)
November 1, 2030
Study Completion (Estimated)
November 1, 2030
Last Updated
July 16, 2025
Record last verified: 2025-07