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)

July 14, 2025 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
    • Tuzlanski
      • Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 130638
  • Bulgaria
      • Sofia, Bulgaria, 1797
        • SHAT Hematologic Diseases /ID# 143572
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Alberta Health Services /ID# 128717
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /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
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc /ID# 127437
      • 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
    • Hradec Kralove
      • Hradec Králové, Hradec Kralove, Czechia, 500 05
        • Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 708 52
        • Fakultni Nemocnice Ostrava /ID# 127913
  • Denmark
    • Hovedstaden
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 13419
        • Tallinn Children's Hospital /ID# 126974
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 51014
        • Children's Clinic Of Tartu Uni /ID# 146017
  • France
      • Paris, France, 75015
        • AP-HP - Hopital Necker /ID# 147702
    • Rhone
      • Bron, Rhone, France, 69677
        • Duplicate_Hôpital Pierre Wertheimer /ID# 128193
  • Germany
      • Forchheim, Germany, 91301
        • Froehlich Gemeinschaftspraxis /ID# 127975
      • Freiburg, Germany, 79106
        • Duplicate_Universitaetsklinikum Freiburg /ID# 130010
      • Munich, Germany, 80634
        • Kinderarztpraxis Neuhausen /ID# 144402
      • Regensburg, Germany, 93042
        • Universitaetsklinikum Regensburg /ID# 137140
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 148444
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Duplicate_Universitaetsklinikum Erlangen /ID# 137274
    • Niedersachsen
      • Munster, Niedersachsen, Germany, 48149
        • Duplicate_Universitaetsklinikum Muenster /ID# 148441
      • Osnabrueck, Niedersachsen, Germany, 49074
        • Christliches Kinderhospital Osnabrueck /ID# 136629
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Universitaetsklinikum Aachen /ID# 126591
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696
  • 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
      • Maroussi, 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
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 162061
      • Haifa, Israel, 34362
        • The Lady Davis Carmel Medical Center /ID# 151519
    • HaMerkaz
      • Petah Tikva, HaMerkaz, Israel, 4920235
        • Schneider Children's Medical Center /ID# 152683
      • Rehovot, HaMerkaz, Israel, 7661041
        • Duplicate_Kaplan Medical Center /ID# 152945
      • Zerifin, HaMerkaz, Israel, 70300
        • Yitzhak Shamir Medical Center /ID# 157182
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5262100
        • Edmond And Lily Safra Children /ID# 148730
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91031
        • Shaare Zedek Medical Center /ID# 144277
  • Italy
      • Bologna, Italy, 40133
        • Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347
      • Messina, Italy, 98125
        • Duplicate_A.O.U. Policlinico G. Martino /ID# 141683
      • Milan, Italy, 20154
        • ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679
      • Naples, Italy, 80131
        • Duplicate_Universita di Napoli Federico II /ID# 144280
      • Palermo, Italy, 90127
        • Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma /ID# 147441
      • Pescara, Italy, 65124
        • Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307
    • Milano
      • Milan, Milano, Italy, 20122
        • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279
    • Roma
      • Rome, Roma, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962
  • 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
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Duplicate_Academisch Medisch Centrum /ID# 141843
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Duplicate_Erasmus Medisch Centrum /ID# 141841
  • Portugal
      • Braga, Portugal, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 138269
      • Porto, Portugal, 4200-319
        • Unidade Local de Saude Sao Joao, EPE /ID# 138146
  • Puerto Rico
      • Mayaguez, Puerto Rico, 00680
        • Ctr. Gastroenterologia Ped Oes /ID# 140875
      • San Juan, Puerto Rico, 00912-3310
        • San Jorge Children Hospital /ID# 138067
  • 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
      • 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
      • A Coruña, A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña /ID# 137235
      • Ferrol, A Coruna, Spain, 15405
        • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Complejo Hospitalario 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
      • Stockholm, Stockholms Lan, Sweden, 118 83
        • Sodersjukhuset /ID# 152685
  • 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
        • Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital /ID# 138013
      • Manchester, United Kingdom, M9 2AA
        • Manchester University NHS Foundation Trust /ID# 128476
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438
      • 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
    • England
      • Sheffield, England, United Kingdom, S10 2TH
        • Sheffield Children's Hospital NHS Foundation Trust /ID# 130370
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 147538
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • Duplicate_NHS Greater Glasgow and Clyde /ID# 127436
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • St Helier Hospital /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 - Aurora /ID# 137261
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center - Hartford /ID# 137265
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine /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, 30342
        • Children's Ctr Digestive, US /ID# 144625
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University /ID# 144274
    • 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
        • Duplicate_UMass Chan Medical School /ID# 148325
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 149245
    • 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
        • Duplicate_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, 98105
        • Seattle Children's Hospital /ID# 140879
      • Seattle, Washington, United States, 98104
        • Duplicate_Swedish Medical Center /ID# 137258
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation /ID# 152120
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent AESI per 100 PYs of infections and malignancies
Time Frame: Up to 10 years
Up to 10 years
Percentage of subjects with SAEs
Time Frame: Up to 10 years
Up to 10 years
Number of treatment-emergent other AESI per 100 PYs
Time Frame: Up to 5 years
Up to 5 years
Percentage of subjects with other AESI
Time Frame: Up to 5 years
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
Time Frame: Up to 10 years
Up to 10 years
Number of subjects with other AESI
Time Frame: Up to 5 years
Number of subjects with AESIs other than infections and malignancies
Up to 5 years
Number of treatment-emergent SAEs per 100 patient years (PYs)
Time Frame: Up to 10 years
Up to 10 years
Number of subjects with Serious Adverse Events (SAEs)
Time Frame: Up to 10 years
Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)
Time Frame: Up to 5 years
Patient completed questionnaires
Up to 5 years
Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame: Up to 5 years
Completed by the patients who are 18 years of age or older
Up to 5 years
Work Productivity and Activity Impairment (WPAI) questionnaire
Time Frame: Up to 5 years
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)
Time Frame: Up to 5 years
Completed by the physician
Up to 5 years
IMPACT III
Time Frame: Up to 5 years
Completed by patients ages 10 through 17 years old
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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