IBDI-CARENCT02377258
IBD Cancer and Serious Infection in Europe
An observational study of IBD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
Trial summary
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD
- What is being tested?
- Non Interventional
- How many people
- 13,262 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2016to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)
Who may be able to join
- CD or UC
- Capable to complete eDiary on a regular basis, and have access to smartphone or internet
- Accepted to participate and provide personal information (name, phone and email) for contact
- Accepted to be contacted by study coordinators on a regular basis for follow up with missing information
Who cannot join
- Unable to sign consent
- Unable to access internet or use smartphone
- Refused to sign consent or to provide personal identification information
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
Read the detailed description
The four main secondary objectives of the I-CARE project are:
- To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
- To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
- To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
- To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years
- use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
- chemoprevention of CRC: first study that will specifically and accurately address this question
- use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
- safety of steroids (infections etc)
STUDY DESIGN:
22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)
- Conditions
- IBD
- Being tested
- Non Interventional
- Keywords
- Lymphoma, safety, biologic therapies
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionalOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed) Receives: Other: Non Interventional | |
| 2 | with on-going anti-TNF monotherapy Receives: Other: Non Interventional | |
| 3 | with thiopurines monotherapy Receives: Other: Non Interventional | |
| 4 | with on-going combination therapy Receives: Other: Non Interventional | |
| 5 | patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy) Receives: Other: Non Interventional | |
| 6 | patients on ustekinumab (alone or on combination therapy) Receives: Other: Non Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
Measured: 3 years
Secondary outcomes (4)
Disease modification
To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalisations
Measured: 3 Years
ePRO
To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
Measured: 3 Years
Benefit-Risk
To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
Measured: 3 Years
Cost Efficacy
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start4 Mar 2016
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- 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
- 13,262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Peyrin-Biroulet, MD, PhD, Principal investigator, Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377258
- Sponsor's protocol ID
- GETAID 2015-01
- Acronym
- I-CARE
- Status last verified
- Aug 2022
- First submitted
- 26 Feb 2015
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirchgesner J, Beaugerie L, Baumann C, Baert F, Rahier JF, Bergemalm D, Canete F, Caron B, Cossignani M, Dias S, Farkas K, Girod P, Goren I, Holvoet T, Krasz S, Kumar A, Rimmer P, Sheridan J, Thut J, Uzzan M, Viazis N, Weimers P, Zagorowicz E, Buisson A, Avedano L, Rousseau H, Peyrin-Biroulet L, Sebastian S; I-CARE Collaborator Group. Building a Robust Investigator-Initiated Platform: The I-CARE Experience. Clin Pharmacol Ther. 2026 Jun;119(6):1537-1546. doi: 10.1002/cpt.70231. Epub 2026 Feb 15.
PubMed 41693257Peyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2026 Jan;58(1):74-81. doi: 10.1016/j.dld.2025.09.026. Epub 2025 Oct 25.
PubMed 41139534Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.
PubMed 36152897
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBD Cancer and Serious Infection in Europe
- ClinicalTrials.gov ID
- NCT02377258
- Acronym / sponsor ID
- I-CARE / GETAID 2015-01
- Conditions
- IBD
- Keywords
- Lymphoma, safety, biologic therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,262 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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 primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
Detailed description
The four main secondary objectives of the I-CARE project are:
- To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
- To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
- To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
- To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years
- use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
- chemoprevention of CRC: first study that will specifically and accurately address this question
- use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
- safety of steroids (infections etc)
STUDY DESIGN:
22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Non Interventionalwithout previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed) |
| 2 | – | Other: Non Interventionalwith on-going anti-TNF monotherapy |
| 3 | – | Other: Non Interventionalwith thiopurines monotherapy |
| 4 | – | Other: Non Interventionalwith on-going combination therapy |
| 5 | – | Other: Non Interventionalpatients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy) |
| 6 | – | Other: Non Interventionalpatients on ustekinumab (alone or on combination therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)
Key inclusion criteria (4 listed)
- CD or UC
- Capable to complete eDiary on a regular basis, and have access to smartphone or internet
- Accepted to participate and provide personal information (name, phone and email) for contact
- Accepted to be contacted by study coordinators on a regular basis for follow up with missing information
Key exclusion criteria (3 listed)
- Unable to sign consent
- Unable to access internet or use smartphone
- Refused to sign consent or to provide personal identification information
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 |
|---|---|---|
| Non Interventional | Other | 1, 2, 3, 4, 5, 6 |
Primary outcome
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
Time frame: 3 years
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
4 secondary outcomes
Disease modification
Time frame: 3 Years
ePRO
Time frame: 3 Years
Benefit-Risk
Time frame: 3 Years
Cost Efficacy
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 41693257Kirchgesner J, Beaugerie L, Baumann C, Baert F, Rahier JF, Bergemalm D, Canete F, Caron B, Cossignani M, Dias S, Farkas K, Girod P, Goren I, Holvoet T, Krasz S, Kumar A, Rimmer P, Sheridan J, Thut J, Uzzan M, Viazis N, Weimers P, Zagorowicz E, Buisson A, Avedano L, Rousseau H, Peyrin-Biroulet L, Sebastian S; I-CARE Collaborator Group. Building a Robust Investigator-Initiated Platform: The I-CARE Experience. Clin Pharmacol Ther. 2026 Jun;119(6):1537-1546. doi: 10.1002/cpt.70231. Epub 2026 Feb 15.
- Derived from this study: PubMed 41139534Peyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2026 Jan;58(1):74-81. doi: 10.1016/j.dld.2025.09.026. Epub 2025 Oct 25.
- Derived from this study: PubMed 36152897Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.
- Baseline characteristics of cohort on 2000 patientsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Laurent Peyrin-Biroulet, MD, PhD principal investigator
Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients. (time frame: 3 years). 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 NCT02377258, which also lists 3 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 3 Aug 2022.