Inflammatory Bowel DiseasesPIBD-SETQNCT03571373
PIBD-SETQuality: the Inception Cohort and Safety Registry
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Erasmus Medical Center at 2 sites in 2 countries.
Trial summary
The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors. Read more about this study
- Who is it for?
- Ages 0 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jan 2017to 31 Dec 2030
- How long will I take part?
- 20 Years
- 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 0 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).
Who may be able to join
- Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:
- Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
- Diagnosis has been made or is confirmed within 2 months of inclusion
- Data on all diagnostic procedures are available for inclusion in the database
- Informed consent of patient (if indicated) and parents has been obtained
- Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet
- Any child with IBD <19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.
Who cannot join
- Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)
- Informed consent of patient or parents has not been obtained when required
- Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC - Sophia Children's Hospital
Rotterdam, 3015GD
Lissy De Ridder, MD, PhD, l.deridder@erasmusmc.nl
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Hospital London
London
Nicholas Croft, MD, PhD, n.m.croft@qmul.ac.uk
About this study
Official title: Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry
The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.
Read the detailed description
In this prospective observational study children with newly diagnosed inflammatory bowel disease (IBD) will be included in the inception cohort. The primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. In order to capture information on rare and severe complications in PIBD as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.
- Being tested
- No intervention
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention due to the observational set-up of this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors for outcome and treatment response or non-response
Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery).
Measured: Over a period of three years after inclusion of the last patient.
Secondary outcomes (2)
New biomarkers as classifiers of response or non-response to therapy
Part of the children in the inception cohort will deliver biological specimens to develop new biomarkers as classifiers of disease risk of complicated disease or side effects in PIBD patients, as well as predictors of (non-)response to a specific immunomodulator or biological agent.
Measured: Over a period of three years after inclusion of the last patient.
Identification of patients with rare and serious complications
Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment.
Measured: Until the end of patients recruitment, for a period of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start3 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Queen Mary University of London, Hôpital Necker-Enfants Malades, Paris
- Responsible party
- Principal investigator, Lissy de Ridder, Erasmus Medical Center
- Investigators
- Lissy de Ridder, Professor, MD, Principal investigator, Erasmus Medical CenterNicholas Croft, Professor, MD, Principal investigator, Barts and the London School of Medicine, Queen Mary University of LondonFrank Ruemmele, Professor, MD, Principal investigator, Hopital Necker-Enfants Malades, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571373
- Sponsor's protocol ID
- PIBD-Net 2016-02
- Acronym
- PIBD-SETQ
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timmer A, Behrens R, Buderus S, Findeisen A, Hauer A, Keller KM, Kliemann G, Lang T, Lohr W, Rzehak P, Koletzko S; CEDATA-GPGE Study Group. Childhood onset inflammatory bowel disease: predictors of delayed diagnosis from the CEDATA German-language pediatric inflammatory bowel disease registry. J Pediatr. 2011 Mar;158(3):467-473.e2. doi: 10.1016/j.jpeds.2010.09.014. Epub 2010 Nov 4.
PubMed 21051046De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132.
PubMed 26835906Vuijk SA, Klomberg RCW, Katgert E, Wessels MMS, Miele E, Cameron FL, Milovanovich ID, Muhammed R, Devadason D, Hart J, Rizopoulos D, Croft NM, de Ridder L; PIBD-SETQuality Consortium; PIBD-SETQuality Consortium. Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study. Crohns Colitis 360. 2026 Jul 3;8(3):otag069. doi: 10.1093/crocol/otag069. eCollection 2026 Jul.
PubMed 42549261Klomberg RCW, Griffiths AM, Aloi M, Kiparissi F, Lawrence S, Otley AR, Critch J, van der Feen C, Rodrigues A, Mack DR, Huynh HQ, Church PC, Rizopoulos D, Croft NM, de Ridder L, Walters TD; European Paediatric IBD Network for Safety, Efficicacy of Treatment and Quality Improvement of Care (PIBD-SETQuality); Canadian Children IBD Network (CIDsCaNN). A comparative analysis of corticosteroids and exclusive enteral nutrition induction therapy in children with small bowel Crohn's disease: results of two prospective cohorts. Eur J Pediatr. 2026 May 19;185(6):413. doi: 10.1007/s00431-026-07061-8.
PubMed 42154069Vuijk SA, Klomberg RCW, Schwerd T, Griffiths AM, Hussey S, Carroll MW, Malmborg P, Deb P, Wessels M, Mouratidou N, van Biervliet S, Friedt M, Minson S, Vrieling-Prince FHM, Croft NM, de Ridder L; PIBD-SETQuality Safety Registry Collaborative Group. Significant kidney impairment in pediatric inflammatory bowel disease and practice points for pediatric gastroenterologists. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1251-1260. doi: 10.1002/jpn3.70391. Epub 2026 Mar 10.
PubMed 41807295Nugteren S, Simons-Oosterhuis Y, Menckeberg CL, Hulleman-van Haaften DH, Lindenbergh-Kortleve DJ, Samsom JN. Endogenous secretory leukocyte protease inhibitor inhibits microbial-induced monocyte activation. Eur J Immunol. 2023 Feb;53(2):e2249964. doi: 10.1002/eji.202249964. Epub 2022 Dec 22.
PubMed 36480463Aardoom MA, Kemos P, Tindemans I, Aloi M, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Russell RK, Walters TD, Ruemmele FM, Samsom JN, Croft NM, de Ridder L; PIBD-SETQuality consortium and PIBD-NET. International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study. BMJ Open. 2020 Jul 1;10(7):e035538. doi: 10.1136/bmjopen-2019-035538.
PubMed 32611739
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry
- ClinicalTrials.gov ID
- NCT03571373
- Acronym / sponsor ID
- PIBD-SETQ / PIBD-Net 2016-02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- European Commission, Queen Mary University of London, Hôpital Necker-Enfants Malades, Paris
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.
Detailed description
In this prospective observational study children with newly diagnosed inflammatory bowel disease (IBD) will be included in the inception cohort. The primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. In order to capture information on rare and severe complications in PIBD as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 0 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).
Key inclusion criteria (7 listed)
- Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:
- Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
- Diagnosis has been made or is confirmed within 2 months of inclusion
- Data on all diagnostic procedures are available for inclusion in the database
- Informed consent of patient (if indicated) and parents has been obtained
Key exclusion criteria (3 listed)
- Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)
- Informed consent of patient or parents has not been obtained when required
- Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention due to the observational set-up of this study. | Other | – |
Primary outcome
Predictors for outcome and treatment response or non-response
Time frame: Over a period of three years after inclusion of the last patient.
Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery).
2 secondary outcomes
New biomarkers as classifiers of response or non-response to therapy
Time frame: Over a period of three years after inclusion of the last patient.
Identification of patients with rare and serious complications
Time frame: Until the end of patients recruitment, for a period of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 21051046Timmer A, Behrens R, Buderus S, Findeisen A, Hauer A, Keller KM, Kliemann G, Lang T, Lohr W, Rzehak P, Koletzko S; CEDATA-GPGE Study Group. Childhood onset inflammatory bowel disease: predictors of delayed diagnosis from the CEDATA German-language pediatric inflammatory bowel disease registry. J Pediatr. 2011 Mar;158(3):467-473.e2. doi: 10.1016/j.jpeds.2010.09.014. Epub 2010 Nov 4.
- Background: PubMed 26835906De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132.
- Derived from this study: PubMed 42549261Vuijk SA, Klomberg RCW, Katgert E, Wessels MMS, Miele E, Cameron FL, Milovanovich ID, Muhammed R, Devadason D, Hart J, Rizopoulos D, Croft NM, de Ridder L; PIBD-SETQuality Consortium; PIBD-SETQuality Consortium. Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study. Crohns Colitis 360. 2026 Jul 3;8(3):otag069. doi: 10.1093/crocol/otag069. eCollection 2026 Jul.
- Derived from this study: PubMed 42154069Klomberg RCW, Griffiths AM, Aloi M, Kiparissi F, Lawrence S, Otley AR, Critch J, van der Feen C, Rodrigues A, Mack DR, Huynh HQ, Church PC, Rizopoulos D, Croft NM, de Ridder L, Walters TD; European Paediatric IBD Network for Safety, Efficicacy of Treatment and Quality Improvement of Care (PIBD-SETQuality); Canadian Children IBD Network (CIDsCaNN). A comparative analysis of corticosteroids and exclusive enteral nutrition induction therapy in children with small bowel Crohn's disease: results of two prospective cohorts. Eur J Pediatr. 2026 May 19;185(6):413. doi: 10.1007/s00431-026-07061-8.
- Derived from this study: PubMed 41807295Vuijk SA, Klomberg RCW, Schwerd T, Griffiths AM, Hussey S, Carroll MW, Malmborg P, Deb P, Wessels M, Mouratidou N, van Biervliet S, Friedt M, Minson S, Vrieling-Prince FHM, Croft NM, de Ridder L; PIBD-SETQuality Safety Registry Collaborative Group. Significant kidney impairment in pediatric inflammatory bowel disease and practice points for pediatric gastroenterologists. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1251-1260. doi: 10.1002/jpn3.70391. Epub 2026 Mar 10.
- Derived from this study: PubMed 36480463Nugteren S, Simons-Oosterhuis Y, Menckeberg CL, Hulleman-van Haaften DH, Lindenbergh-Kortleve DJ, Samsom JN. Endogenous secretory leukocyte protease inhibitor inhibits microbial-induced monocyte activation. Eur J Immunol. 2023 Feb;53(2):e2249964. doi: 10.1002/eji.202249964. Epub 2022 Dec 22.
- Derived from this study: PubMed 32611739Aardoom MA, Kemos P, Tindemans I, Aloi M, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Russell RK, Walters TD, Ruemmele FM, Samsom JN, Croft NM, de Ridder L; PIBD-SETQuality consortium and PIBD-NET. International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study. BMJ Open. 2020 Jul 1;10(7):e035538. doi: 10.1136/bmjopen-2019-035538.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lissy de Ridder, Professor, MD principal investigator
Erasmus Medical Center
Nicholas Croft, Professor, MD principal investigator
Barts and the London School of Medicine, Queen Mary University of London
Frank Ruemmele, Professor, MD principal investigator
Hopital Necker-Enfants Malades, Paris
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Erasmus Medical Center at 2 sites in 2 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. 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?
Contact Lissy de Ridder, Professor, MD (+31715262824, l.deridder@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors for outcome and treatment response or non-response (time frame: Over a period of three years after inclusion of the last patient.). 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 NCT03571373, which also lists 7 linked publications.
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 11 Aug 2026.