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Crohn's DiseaseCAPENCT02130362

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)

An observational study of Crohn's Disease, run by AbbVie at 148 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Crohn's Disease
How many people
1,446 participants
Where
148 sitesin 22 countries
Study dates
28 Aug 2014to Nov 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

148 sites in 22 countries.

148 sites in 22 countries

United States45 sites

  • Winship Cancer Institute of Emory University /ID# 144274

    Atlanta, Georgia, 30322

  • Children's Ctr Digestive, US /ID# 144625

    Atlanta, Georgia, 30342

  • Children's Hospital Colorado - Aurora /ID# 137261

    Aurora, Colorado, 80045

  • Univ Alabama, Birmingham CCC /ID# 146060

    Birmingham, Alabama, 35294-3300

  • Tufts Medical Center /ID# 143581

    Boston, Massachusetts, 02111-1552

  • Massachusetts General Hospital /ID# 141552

    Boston, Massachusetts, 02114

  • Boston Children's Hospital /ID# 164102

    Boston, Massachusetts, 02115

  • Women and Childrens Hosp /ID# 143778

    Buffalo, New York, 14222

  • University Of Vermont Medical /ID# 137263

    Burlington, Vermont, 05405

  • Univ NC Chapel Hill /ID# 137236

    Chapel Hill, North Carolina, 27514-4220

  • Duplicate_Medical University of South Carolina /ID# 144473

    Charleston, South Carolina, 29425

  • Children's Medical Center /ID# 149256

    Dallas, Texas, 75235

  • Geisinger Medical Center /ID# 149910

    Danville, Pennsylvania, 17822

  • Duke Cancer Center /ID# 137268

    Durham, North Carolina, 27710-3000

  • Pediatric Specialty of VA /ID# 142831

    Fairfax, Virginia, 22031

  • Cook Children's Med. Center /ID# 144474

    Fort Worth, Texas, 76104

  • Connecticut Children's Medical Center - Hartford /ID# 137265

    Hartford, Connecticut, 06106

  • Penn State Child Hosp.Hersh,PA /ID# 144476

    Hershey, Pennsylvania, 17033

  • Texas Children's Hospital /ID# 148211

    Houston, Texas, 77030-2608

  • Univ of Mississippi Med Ctr,US /ID# 137239

    Jackson, Mississippi, 39216-4643

  • Nemours Children's Health System /ID# 148498

    Jacksonville, Florida, 32207

  • Children's Hospital Los Angeles /ID# 141551

    Los Angeles, California, 90027

  • Private practice: Dr. Shervin Rabizadeh /ID# 137269

    Los Angeles, California, 90048

  • University of Miami /ID# 140893

    Miami, Florida, 33136

  • Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259

    Milwaukee, Wisconsin, 53226

  • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238

    Minneapolis, Minnesota, 55455

  • University of South Alabama /ID# 137255

    Mobile, Alabama, 36617

  • Goryeb Children's Hospital /ID# 144275

    Morristown, New Jersey, 07960

  • Yale University School of Medicine /ID# 137257

    New Haven, Connecticut, 06510

  • CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266

    New Hyde Park, New York, 11042-2057

  • Children's Hospital New Orleans /ID# 144477

    New Orleans, Louisiana, 70118

  • Columbia Univ Medical Center /ID# 144440

    New York, New York, 10032-3725

  • Columbia Univ Medical Center /ID# 144475

    New York, New York, 10032-3725

  • Children's Hospital Oklahoma /ID# 144047

    Oklahoma City, Oklahoma, 73104

  • Phoenix Children's Hospital /ID# 141336

    Phoenix, Arizona, 85016-7710

  • Maine Medical Partners /ID# 147685

    Portland, Maine, 04102

  • Mayo Clinic - Rochester /ID# 149245

    Rochester, Minnesota, 55905-0001

  • Rady Children's Hospital San Diego /ID# 140883

    San Diego, California, 92123

  • Univ California, San Francisco /ID# 141312

    San Francisco, California, 94143-2204

  • Duplicate_Swedish Medical Center /ID# 137258

    Seattle, Washington, 98104

  • Seattle Children's Hospital /ID# 140879

    Seattle, Washington, 98105

  • Univ Med Ctr at Stony Brook /ID# 140913

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University /ID# 148437

    Syracuse, New York, 13210

  • MultiCare Institute for Research & Innovation /ID# 152120

    Tacoma, Washington, 98405

  • Duplicate_UMass Chan Medical School /ID# 148325

    Worcester, Massachusetts, 01655

Other trials in United States

Spain23 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 137235

    A Coruña, A Coruna, 15006

  • Hospital Universitario Germans Trias i Pujol /ID# 139400

    Badalona, Barcelona, 08916

  • OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781

    Barakaldo, Vizcaya, 48903

  • Hospital Universitario Vall d'Hebron /ID# 141778

    Barcelona, 08035

  • Hospital Universitario Vall d'Hebron /ID# 146015

    Barcelona, 08035

  • Hospital General de Granollers /ID# 140882

    Barcelona, 08042

  • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460

    El Palmar, Murcia, 30120

  • Hospital Sant Joan de Deu /ID# 152059

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462

    Ferrol, A Coruna, 15405

  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572

    Girona, 17007

  • Hospital Universitario Severo Ochoa /ID# 141545

    Leganés, Madrid, 28911

  • Hospital Infantil Universitario Nino Jesus /ID# 165738

    Madrid, 28009

  • Hospital Universitario 12 de Octubre /ID# 136998

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 161152

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga /ID# 144289

    Málaga, 29011

  • Hospital Universitario Central de Asturias /ID# 163053

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitari Son Espases /ID# 147446

    Palma de Mallorca, Balearic Islands, 07120

  • Compl Hospital Univer de Vigo /ID# 136999

    Pontevedra, 36312

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029

    Sabadell, Barcelona, 08208

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 141667

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Dr. Peset /ID# 159484

    Valencia, 46017

  • Hospital Universitario y Politecnico La Fe /ID# 141847

    Valencia, 46026

Other trials in Spain

United Kingdom13 sites

  • NHS Grampian /ID# 131296

    Aberdeen, AB15 6RE

  • Birmingham Women's and Children's NHS Foundation Trust /ID# 136631

    Birmingham, B4 6NH

  • Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779

    Cambridge, CB2 0QQ

  • St Helier Hospital /ID# 150097

    Carshalton, Surrey, SM5 1AA

  • University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592

    Derby, Derbyshire, DE22 3NE

  • Duplicate_NHS Greater Glasgow and Clyde /ID# 127436

    Glasgow, Scotland, G12 0XH

  • Alder Hey Children's Hospital /ID# 138013

    Liverpool, L12 2AP

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471

    London, Greater London, E1 2ES

  • Manchester University NHS Foundation Trust /ID# 128476

    Manchester, M9 2AA

  • Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438

    Newcastle upon Tyne, NE7 7DN

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 130370

    Sheffield, England, S10 2TH

  • University Hospital Southampton NHS Foundation Trust /ID# 147538

    Southampton, Hampshire, SO16 6YD

  • St George's University Hospitals NHS Foundation Trust /ID# 131590

    Tooting, SW17 0QT

Other trials in United Kingdom

Germany10 sites

  • Universitaetsklinikum Aachen /ID# 126591

    Aachen, North Rhine-Westphalia, 52074

  • Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696

    Dresden, Saxony, 01307

  • Duplicate_Universitaetsklinikum Erlangen /ID# 137274

    Erlangen, Bavaria, 91054

  • Froehlich Gemeinschaftspraxis /ID# 127975

    Forchheim, 91301

  • Duplicate_Universitaetsklinikum Freiburg /ID# 130010

    Freiburg im Breisgau, 79106

  • Kinderarztpraxis Neuhausen /ID# 144402

    Munich, 80634

  • Duplicate_Universitaetsklinikum Muenster /ID# 148441

    Munster, Lower Saxony, 48149

  • Christliches Kinderhospital Osnabrueck /ID# 136629

    Osnabrück, Lower Saxony, 49074

  • Universitaetsklinikum Regensburg /ID# 137140

    Regensburg, 93042

  • Universitaetsklinikum Ulm /ID# 148444

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Italy10 sites

  • Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347

    Bologna, 40133

  • Duplicate_A.O.U. Policlinico G. Martino /ID# 141683

    Messina, 98125

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279

    Milan, Milano, 20122

  • ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679

    Milan, 20154

  • Duplicate_Universita di Napoli Federico II /ID# 144280

    Naples, 80131

  • Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410

    Palermo, 90127

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684

    Palermo, 90146

  • Azienda Ospedaliero-Universitaria di Parma /ID# 147441

    Parma, 43126

  • Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307

    Pescara, 65124

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962

    Rome, Roma, 00161

Other trials in Italy

Israel8 sites

  • Duplicate_Ha'Emek Medical Center /ID# 156316

    Afula, 18341

  • Rambam Health Care Campus /ID# 162061

    Haifa, 3109601

  • The Lady Davis Carmel Medical Center /ID# 151519

    Haifa, 34362

  • Shaare Zedek Medical Center /ID# 144277

    Jerusalem, Jerusalem, 91031

  • Schneider Children's Medical Center /ID# 152683

    Petah Tikva, Central District, 4920235

  • Edmond And Lily Safra Children /ID# 148730

    Ramat Gan, Tel Aviv, 5262100

  • Duplicate_Kaplan Medical Center /ID# 152945

    Rehovot, Central District, 7661041

  • Yitzhak Shamir Medical Center /ID# 157182

    Ẕerifin, Central District, 70300

Other trials in Israel

Canada5 sites

  • Alberta Health Services /ID# 128717

    Edmonton, Alberta, T6G 1C9

  • IWK Health Center /ID# 127912

    Halifax, Nova Scotia, B3K 6R8

  • The Univ of Western Ontario /ID# 137962

    London, Ontario, N6A 5K8

  • Hospital for Sick Children /ID# 127910

    Toronto, Ontario, M5G 1X8

  • Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Czechia5 sites

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521

    Hradec Králové, Hradec Kralove, 500 05

  • Fakultni nemocnice Olomouc /ID# 127437

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava /ID# 127913

    Ostrava, Ostrava-mesto, 708 52

  • Fakultni nemocnice Kralovske Vinohrady /ID# 127697

    Prague, 100 34

  • Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829

    Ústí nad Labem, 401 13

Other trials in Czechia

Greece5 sites

  • Agia Sofia Hospital /ID# 134349

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690

    Athens, Attica, 11527

  • Venizeleio General Hospital /ID# 147335

    Heraklion, 71409

  • Iatriko Kentro Athinon /ID# 130639

    Marousi, Attica, 15125

  • General Hospital of Thessaloniki Gennimatas /Id# 163658

    Thessaloniki, 54635

Other trials in Greece

Romania4 sites

  • Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358

    Bucharest, 011743

  • Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297

    Cluj-Napoca, Cluj, 400177

  • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014

    Târgu Mureş, 540136

  • Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251

    Timișoara, Timiș County, 500063

Other trials in Romania

Croatia2 sites

  • Zadar General Hospital /ID# 129830

    Zadar, 23000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 128256

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Estonia2 sites

  • Tallinn Children's Hospital /ID# 126974

    Tallinn, Harju, 13419

  • Children's Clinic Of Tartu Uni /ID# 146017

    Tartu, Tartu, 51014

Other trials in Estonia

France2 sites

  • Duplicate_Hôpital Pierre Wertheimer /ID# 128193

    Bron, Rhone, 69677

  • AP-HP - Hopital Necker /ID# 147702

    Paris, 75015

Other trials in France

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 127810

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Duplicate_Academisch Medisch Centrum /ID# 141843

    Amsterdam, North Holland, 1105 AZ

  • Duplicate_Erasmus Medisch Centrum /ID# 141841

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Portugal2 sites

  • 2CA-Braga, Hospital de Braga /ID# 138269

    Braga, 4710-243

  • Unidade Local de Saude Sao Joao, EPE /ID# 138146

    Porto, 4200-319

Other trials in Portugal

Puerto Rico2 sites

  • Ctr. Gastroenterologia Ped Oes /ID# 140875

    Mayagüez, 00680

  • San Jorge Children Hospital /ID# 138067

    San Juan, 00912-3310

Other trials in Puerto Rico

Sweden2 sites

  • Karolinska University Hospital Solna /ID# 129045

    Solna, Stockholm County, 171 64

  • Sodersjukhuset /ID# 152685

    Stockholm, Stockholm County, 118 83

Other trials in Sweden

Bosnia and Herzegovina1 site

  • University Clinical Center Tuzla /ID# 130638

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Bulgaria1 site

  • SHAT Hematologic Diseases /ID# 143572

    Sofia, 1797

Other trials in Bulgaria

Denmark1 site

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013

    Hvidovre, Capital Region, 2650

Other trials in Denmark

Ireland1 site

  • Our Lady's Hospital /ID# 127438

    Manorhamilton, Leitrim

Other trials in Ireland

About this study

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

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.

Conditions
Crohn's Disease
Keywords
Crohn's Disease, Registry, Adalimumab, Crohn's, Inflammatory Bowel Diseases, Gastrointestinal Diseases
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02130362
Study groupRoleWhat they receive
Immunosuppressant TherapyPediatric patients who are being prescribed and treated with immunosuppressant therapy
Adalimumab (Humira) TreatmentPediatric patients who are prescribed and treated with adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment-emergent AESI per 100 PYs of infections and malignancies

    Measured: Up to 10 years

  2. Percentage of subjects with SAEs

    Measured: Up to 10 years

  3. Number of treatment-emergent other AESI per 100 PYs

    Measured: Up to 5 years

  4. Percentage of subjects with other AESI

    Percentages of subjects with AESIs other than infections and malignancies

    Measured: Up to 5 years

  5. Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies

    Measured: Up to 10 years

  6. Number of subjects with other AESI

    Number of subjects with AESIs other than infections and malignancies

    Measured: Up to 5 years

  7. Number of treatment-emergent SAEs per 100 patient years (PYs)

    Measured: Up to 10 years

  8. Number of subjects with Serious Adverse Events (SAEs)

    Measured: Up to 10 years

  9. Percentage of subjects with AESI of infections, malignancies, and pregnancies

    Measured: Up to 10 years

Secondary outcomes (5)

  1. Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)

    Patient completed questionnaires

    Measured: Up to 5 years

  2. Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Completed by the patients who are 18 years of age or older

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

  4. Physician's Global Assessment of Disease Activity (PGA)

    Completed by the physician

    Measured: Up to 5 years

  5. IMPACT III

    Completed by patients ages 10 through 17 years old

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2014 (estimated)
  2. Study start28 Aug 2014
  3. Primary completionNov 2030 (estimated)
  4. Study completionNov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02130362
Sponsor's protocol ID
P11-292
Acronym
CAPE
Status last verified
Jul 2025
First submitted
1 May 2014
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie at 148 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Spain, United Kingdom, Germany, Italy and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment-emergent AESI per 100 PYs of infections and malignancies (time frame: Up to 10 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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