Research Projects

IBD National Study Group meeting at the ECCO Congress

Since IBD National Study Groups often come up with solid clinical research questions but face problems with recruiting a decent number of patients, the Clinical Research Committee of ECCO (ClinCom) decided to organise a meeting for representatives of European IBD National Study Groups to meet and to exchange views on study projects. The 1st edition of the IBD National Study Group meeting took place at the ECCO Congress 2016 Amsterdam, with the clear aim to support the collaboration among study groups. Following the successful experience, the IBD National Study Group meeting now takes place on a yearly basis, at the ECCO Congress.

Prior to the meeting, a call for study proposals is sent to the IBD Community, to give investigators the opportunity to present their study projects directly to representatives of IBD National Study Groups, to challenge their ideas and foster interest. Each protocol received goes through a free and thorough assessment in two stages (see details in section “Review of Study Protocol: A Two-Stage Process).

Which kind of studies are presented at the IBD National Study Group meeting?

        • Multicentric studies, executed predominantly in Europe
        • Studies with simple and practical designs, with the goal to recruit a high number of patients
        • Observational, non-interventional and retrospective studies. Randomised clinical trials are not recommended as these studies generally require a highly complex design
        • Studies proposed by independent researchers (investigation must be independent of industry interests)

   

The new Call for the Research Projects 2025 is now open.
Please see all the information by clicking the button below.
Deadline postponed to November 11, 2024

Research Projects Fact Sheet

Submit your project via email at This email address is being protected from spambots. You need JavaScript enabled to view it.

Review of study protocol: A two-stage process

The assessment of a clinical research protocol encompasses a two-stage process. During the first stage, applicants are called upon to provide a study synopsis including background, design, objectives, outcome parameters, major inclusion and exclusion criteria, statistics, and co-variates not exceeding 4 pages. The first stage’s template is sent by the ECCO Office to the interested submitters upon request, once the call is issued.

Once this first stage application is submitted, the project is reviewed by ClinCom who decides to either support or decline the presentation at the National Study Group Meeting. After the meeting, the PI is invited to submit a full protocol (2nd stage) taking into account the feedback given during the IBD National Study Group meeting. A 2nd stage template is sent by the ECCO Office to the PI.

After the review and approval of the 2nd stage protocol by ClinCom and by the ECCO Governing Board, ECCO offers to support the dissemination of a call to participate to the study project among the IBD Community, to support the recruitment of centres. ECCO does not provide any financial or logistical support to studies. The review by ClinCom of a study protocol is not an ECCO endorsement to the project. It is not allowed to use ECCO’s name and logo to promote a study. ClinCom’s support should be acknowledged in any publication.
Should you have any questions, please contact the ECCO Office (This email address is being protected from spambots. You need JavaScript enabled to view it.)

Open research studies

International, Multi-centre, Retrospective Cohort Study on Morbidity, Frequency Rates and Timings of Surgical Interventions for Ulcerative Colitis
Project leaders:

Mr Orestis Argyriou (Research fellow)
Dr Itai Ghersin (Research fellow)
Mr Guy Worley (Consultant colorectal surgeon)
Mr Kapil Sahnan (Consultant colorectal surgeon)
Professor Ailsa Hart (Consultant gastroenterologist)
Purpose and outcome:

This study intends to serve as a snapshot of the current practices in surgery for ulcerative colitis (UC) in Europe, by holistically assessing patients’ surgical journey, starting from the index subtotal colectomy.

The main aims of the study are to:

  1. Document morbidities and complications of procedures in UC in a large sample size
  1. Describe and understand variations in practice, particularly regarding reconstruction:
  • Choice of reconstructive technique
  • Stages used in IPAA surgery
  • Timings between stages in IPAA surgery
  • Surgical technique

To achieve the above, the main outcome parameters that will be assessed, are:

  • Morbidity after total/subtotal colectomy
  • Morbidity after any type of restorative surgery/stages
  • Percentage of patients that proceed with restorative surgery after colectomy (and which type)
  • Percentage of IPAA surgery performed in 1, 2 or 3 stages
  • Percentage of patients, following restorative surgery, that proceed with revisional surgery, excision or diversion, with respective morbidities.
Deadline to Participate:

October 11, 2024
Target group:

Collaborators/Centre inclusion criteria

  • Any European or UK hospital performing surgery for patients with UC (irrespective of volume)

Patient inclusion criteria

  • Age > 18 years old
  • Diagnosis of UC
  • Index colectomy for UC
Invitation Letter:

invitation letter
Maintenance therapy after an episode of steroidresponsive Acute Severe Ulcerative Colitis: what is the best strategy?
Project leaders:
 Ana Catarina Bravo, Joana Revés, Catarina Frias Gomes, Joana Torres
Purpose and outcome:

Purpose: study the course of steroid-responsive ASUC patients,

stratified by the type of medical therapy offered (advanced therapy vs 5 ASA/IMM).

  • Primary outcome: Time until disease relapse/complication after ASUC episode.
  • Secondary outcomes: Time until therapy escalation; Time until need for steroids; Time until hospitalization due to UC; Time until colectomy; Percentage of semesters with inactive disease.
Deadline to Participate: 

October 11, 2024
Target group: Adult patients with an ASUC episode according to Truelove and Witts Criteria who responded to IV steroids according to Oxford Criteria, between 01/01/2010 and 31/12/2021.
Invitation Letter:

 invitation letter
HEmorrhoidAl Disease in Inflammatory Bowel Disease (HEAD-IBD-II): A Multicentre Prospective Cohort Study
Project leaders:
 Ugo Grossi, Gaetano Gallo, Carla Felice
Purpose and outcome: To evaluate the safety and effectiveness of surgical treatments for hemorrhoidal disease in a large multicentre cohort of IBD patients based on clinical and surgical outcomes
Deadline to Participate: 

October 11, 2024
Target group: Adults with a current diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease
Invitation Letter:

 invitation letter
Sequencing JAK-inhibitors in ulcerative colitis: effectiveness and safety of switching within treatment class
Project leaders:

Tommaso Innocenti, MD, PhD student1; Gabriele Dragoni, MD, PhD1; Jurij Hanžel, MD, PhD2; Triana Lobaton, MD, PhD3

  1. IBD Referral Centre, Careggi University Hospital, Florence, Italy
  2. Department of Gastroenterology, UMC Ljubljana, Ljubljana, Slovenia
  3. Department of Gastroenterology, University Hospital Ghent, Ghent, Belgium
Purpose and outcome:

Rationale: Treatment failure remains a significant obstacle in the management of patients with ulcerative colitis, despite many new medications have been released. Switching within drug class is a valuable option for patients who lost response to an anti-TNF, but this is generally not recommended for patients with a primary non-response to a drug of the same class. However, less is known about the effectiveness and safety of cycling JAK-inhibitors within drug class in ulcerative colitis, although this is supported by some data in rheumatology. The aim of this retrospective multicentre European real-world study is to assess the effectiveness and safety of within treatment class switch for JAK-inhibitors in patients with ulcerative colitis having already been treated with a JAK-inhibitor.

Primary outcome: steroid-free clinical remission after a 12-week treatment with a second JAK-inhibitor in patients previously exposed to a JAK-inhibitor.

Secondary outcomes: clinical response at 12, 26 and 52 weeks; steroid-free clinical remission at 26 and 52 weeks; endoscopic improvement/remission at 26 and 52 weeks; CRP normalisation and biochemical remission at 12, 26 and 52 weeks; treatment persistence; start of a 3rd JAK inhibitor in patients who stop treatment.

Safety outcomes: serious adverse events, (colectomy, IBD-related or non-related hospitalisation, malignancy, death), infections including Herpes Zoster reactivations, major adverse cardiac events, abnormalities of the blood lipid panel and/or need for statins, abnormalities of the whole blood count, venous thrombo-embolic events, and acne
Deadline to Participate: 

October 11, 2024
Target group:
  • All IBD centres which kept track of all medical treatment of patients with ulcerative colitis
  • All IBD centres who are willing to fill out a complete REDCap® eCRF for all eligible patients, by doing everything to avoid missing data
All IBD centres who are willing to ask for approval to the local Ethics Committees according to the local jurisdiction
Invitation Letter

 invitation letter
EVOKE - Evaluation of the long-term outcomes of Crohn’s disease complicating intra-abdominal abscess - retrospective, multicentre cohort study
Project leaders:
 Prof. Tamás Molnár, MD, PhD principal investigator; Péter Bacsur, MD, PhD Student
Purpose and outcome:

The global aim of the study to assess the efficacy and safety of elective surgical intervention of intra-abdominal abscess compared to pharmacotherapeutic management after successful PD in CD patients.

The primary outcome is abscess recurrence, defined as the development of an enhancing fluid collection at the same site as the initial lesion after documented resolution.

Secondary outcomes are: All intestinal stoma rate defined as a need of a new stoma during FU connected to resection due to abdominal abscess. Permanent intestinal stoma rate, defined as a need of a new permanent stoma during FU connected to resection due to abdominal abscess, assessed at the day of the operation by colorectal surgeon. Post-procedural (PD and surgery) complications rate. Drain drop out, drain closure, catheter associated infection, surgical site infections etc. Surgery associated complications are defined the occurrence of any complications within 30 days after surgery. Adverse events. Severe infection, sepsis, thromboembolism etc
Deadline to Participate: 

October 11, 2024
Target group: Participation is open to all IBD centers with a medium-high IBD incidence who has retrospective data of CD patients complicating simplex intra-abdominal abscess and willingness to collect and share it.
Invitation Letter:

 invitation letter
Feasibility and safety of endoscopic submucosal dissection in inflammatory bowel disease: a multicenter European retrospective analysis (ESDEUR-IBD)
Project leaders:

María José García1, MD; Miguel Fraile2, PhD

  1. IBD Unit, Gastroenterology and Hepatology Department, Hospital Universitario Marqués de Valdecilla, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Santander, Spain.
  2. Endoscopy Unit, Gastroenterology and Hepatology Department, Hospital Universitario Marqués de Valdecilla, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Santander, Spain. 
Purpose and outcome:

Rational: Colectomy is the main treatment for dysplastic lesions. However, since the development of advanced endoscopic techniques, the management of dysplasia is evolving. Endoscopic resection and endoscopic submucosal resection have been suggested in selected cases and referral centres. However, the feasibility and safety of this technique in IBD patients is still lacking. 

Purpose: The purpose of the study is to obtain information about the feasibility of endoscopic submucosal dissection (ESD) and colectomy rate due to ESD failure in inflammatory bowel disease (IBD) patients.  

Primary outcome:

  • To evaluate en-bloc resection rate (technical success) and colectomy due to ESD failure (clinical success) in IBD patients.

Secondary outcomes:

  • To describe the immediate and delayed complications of ESD
  • To assess the local recurrence of ESD
  • To identify predictive factors for colectomy due to ESD failure
  • To investigate the presence of synchronous and metachronous lesions during surveillance colonoscopies
  • To assess the risk of IBD relapse following ESD
Deadline to Participate: 

October 11, 2024
Target group:

Target group:

  • IBD centres who have performed ESD in IBD patients
  • IBD centres who are willing to fill out an electronic clinical research form (eCRF) through REDCap® software

Inclusion criteria:

  • Patients older than 18 years who underwent ESD at least one month before the date of inclusion. All ESD procedures since 2004 could be included, when this technique was described for colonic lesions.
  • Ulcerative colitis, Crohn’s disease, or unclassified IBD diagnosed at least 3 months before ESD.

Exclusion criteria:

  • Pregnancy
  • Invisible dysplasia at the time of ESD
  • Total colectomy before ESD procedure
Invitation Letter:

 invitation letter
Assessing the effect of newer treatment molecules for IBD on extra- intestinal manifestations and concurrent immune mediated inflammatory diseases
Project leaders:

Dr. Marie Truyens1
Prof. Dr. Triana Lobatón

1 Department of Gastroenterology, University hospital Ghent, Belgium
Purpose and outcome: The aim of the current project is to assess the response and remission rates of extra-intestinal manifestations (EIMs) and immune mediated inflammatory disorders (IMIDs) after initiation of a JAK-inhibitor or anti-IL23 treatment for IBD.
Deadline to Participate: 

October 11, 2024
Target group: All IBD centres with information on the evolution of EIMs and IMIDs during treatment with JAK- and IL-23 inhibitors for IBD.
Invitation Letter:

 invitation letter
Evaluation of organizational and healthcare provider level readiness in European IBD centres for outcomes-based quality improvement cycles
Project leaders:
 Mariam Ali
Purpose and outcome:

This study aims to assess how patient care outcomes are used to improve the quality of care. We also examine whether key resources needed to monitor and implement these outcomes for quality improvement are available in European IBD centres. Finally, we evaluate the association between characteristics of IBD centres and healthcare professionals to the successful implementation of outcomes-based quality improvement. The results of this study will provide insight into the current state of outcomes-based quality improvement in Europe and identify factors associated with successful implementation.
Deadline to Participate: 

October 11, 2024
Target group: Survey: IBD Gastroenterologists from European IBD centres
Invitation Letter:

invitation letter

Ongoing - Prior Years

Fidaxomicin for Clostridium difficile Infection in IBD: a multicenter retrospective cohort study
Project leaders:

Prof. Flavio Caprioli, Dr. Daniele Noviello
University of Milan and Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Purpose and outcome:

Patients with inflammatory bowel disease (IBD) have an increased risk of Clostridium difficile Infection (CDI) and IBD patients with CDI have a higher rate of IBD exacerbation. In the general population, oral vancomycin and fidaxomicin are equally effective in treating CDI though recurrence rates are lower for fidaxomicin. Data on fidaxomicin in IBD patients are very limited, mostly from small single-center studies. The aim of this study is to assess long-term outcomes, predictors of efficacy, and safety of fidaxomicin in a large cohort of IBD patients.

The primary outcome is the CDI recurrence rate, defined as a positive test result for C. difficile toxin plus treatment with any antimicrobial directed at CDI, within 8 weeks after treatment of an initial episode of CDI. 

The secondary outcomes include: sustained response rate, escalation of IBD therapy rate, colectomy rate, all-cause mortality.
Target group: All IBD centres who are willing to fill out a REDCap® eCRF for all eligible patients
Invitation Letter:

 invitation letter
An audit on fertility and pregnancy after surgery for IBD
Project leaders:
 Prof. Gianluca Pellino, Dr. Alice Gori, Prof. Matteo Rottoli, Mr. Valerio Celentano, Salvatore Leone , Prof. Antonino Spinelli, Prof. Giuseppe S. Sica, Prof. Gianluca Sampietro, Prof. Francesco Selvaggi
Purpose and outcome:

Colorectal surgery centers from any country with high IBD incidence (>/= 50 patients in the study period) will be eligible for the study. Each center will create a work team composed by: 1 Hospital lead/Principal Investigator, 3 collaborators, 1 data validator.

Inclusion criteria

  • All female patients who underwent surgery for CD or UC before the age of 36 (at the time of the study) from 2000 to 2022.
  • Diagnosis of Crohn's disease or ulcerative colitis
  • Ability to understand the study
  • For the non-surgical group, all patients who received treatment for CD or UC from 2000 to 2022 will be considered

Exclusion criteria

  • ˂ 18 years of age at the time of the study
Lack of diagnostic certainty of Crohn's disease or ulcerative colitis
Target group: Participation is open to all IBD centers with a medium-high IBD incidence who has retrospective data of CD patients complicating simplex intra-abdominal abscess and willingness to collect and share it.
Invitation Letter:

invitation letter

Closed research studies

2022

Ustekinumab as a Second-line therapy after Anti-integrin Failure in anti-TNFα naïve patients – real-life international data on safety and Efficacy

Project leaders:
 João A. Cunha Neves, MD*; Joana Roseira, MD, PhD student*; Helena Tavares de Sousa, MD, PhD student*
*Gastroenterology Department – CHUA – Centro Hospitalar Universitário do Algarve, Portimão, Portugal
Purpose and outcome:

Rational: Vedolizumab and ustekinumab are considered the top-tier safest biologic medications for inflammatory bowel disease (IBD). Both these drugs are important therapeutic options in a particular pool of patients not suitable to anti-TNFα drugs, namely those with present or previous malignancies and elderly. Once vedolizumab failure is established, most patients will be offered ustekinumab therapy, and robust evidence on efficacy and safety of this second-line treatment regimen in this setting is lacking.

Research hypothesis:
1) Efficacy of ustekinumab will be less impacted by vedolizumab exposure compared to anti-TNFα exposure.
2) Safety profiles will be similar between ustekinumab after vedolizumab and ustekinumab after anti-TNFα.

Primary objective: To assess clinical remission of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients.

Secondary objectives:
1) To assess the durability of ustekinumab as second-line treatment after vedolizumab failure versus after anti-TNFα failure.
2) To assess objective (decrease in biomarker) efficacy of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients.
3) To assess endoscopic efficacy (response and remission) of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients.
4) To compare the efficacy of ustekinumab as second-line treatment after vedolizumab failure versus after anti-TNFα failure.
5) To assess the safety profile of ustekinumab either after vedolizumab or after anti-TNFα.
Target group: Every IBD centre with a retrospective database or list of adult IBD patients, with easily retrievable data and a low risk of missed cases, who are willing to provide information about their patients.
Results:

Not-Finalized

Long-term follow-up of checkpoint inhibitors-induced ileo-colitis

Project leaders:

Department of medical sciences, University of Turin, Turin, Italy.

Internal medicine, Department of internal medicine, IRCCS San Matteo Hospital Foundation, University of Pavia, Pavia, Italy
Purpose and outcome:

The main objective of this study is the evaluation of the incidence rate of colitis remission basing on the CTCAE scale within 12 months.


Secondary objectives of the study are:
1. to evaluate the clinical remission with specific colitis CTCAE scale and with the Physician Global Assessment (PGA)
2. to assess endoscopic and histological healing, whether the endoscopic examination is repeated after the diagnosis.
3. to evaluate the fatality rate and the causes of death among these patients; these will be calculated by gathering information on the modality of death during the follow-up period.
4. to identify all the different patterns of this kind of enterocolitis, by collecting data on the localisation (colonic, ileal, ileo-colonic), the endoscopic (ulcerative, oedematous) and histological features (granulomatosis, crypt abscesses, etc.), and their related prognosis.
5. to describe any epidemiological features of CIC such as male/female ratio, mean age, smoking habits, previous oncological treatments, tumour localisation and will assess any predictors of colitis development or clinical response to colitis-related treatment.
Target group:
  • Any IBD, gastroenterological, oncological, or internal medicine center dealing with ICIC that are willing to provide data with an (expected) date of delivery of 31st December 2022 for the retrospective part and to enroll prospectively patients from January 2023 to December 2023 and follow them up for 12 months (prospective part)
  • All centers that are willing to ask for approval to their local ethics committee, according to their local jurisdiction; each center will be responsible for the submission to the local ethics committee
Results:

Presentation at National Study Group meeting at ECCO’18. Project reviewed by ClinCom. GB approved the promotion of the survey to ECCO Community. Dissemination started in December 2022. Conference Paper, 30° Congresso Nazionale delle Malattie Digestive FISMAD. DOI: 10.1016/S1590-8658(24)00431-6

PANDORA: A European study about prevalence, clinical management and outcome  of acute pancreatitis in IBD

Project leaders:

Pancreas Institute, University of Verona, Italy
Purpose and outcome:

The primary aim of the study is to evaluate the prevalence of AP in IBD patients.

Secondary aims include:

  • To investigate the aetiology of AP in IBD patients
  • To investigate the relationship between IBD medications and AP
  • To investigate the relationship between IBD medications and CPEE
  • To define the role of different imaging modalities in improving diagnosis of pancreatic abnormalities
The explore the clinical outcome of specific pancreatic manifestations
Target group: Each IBD center which maintain a prospective or retrospective list of adult IBD patients, with easily retrievability of data and a low risk of missed cases, who are willing to provide information about their patients with one or more pancreatic disorders
Results: Conference paper DDW 2024 – DOI: 10.1016/S0016-5085(24)03053-1

Case controlled study of UC patients undergoing surgery after TOFA vs biologics

Project leaders:

Careggi University Hospital, Firenze, Italy
Purpose and outcome:

The aim of this study would be to determine the safety of TOFA administration in the weeks before total colectomy for medically refractory UC.

In addition, a subsequent analysis on potential predictive factors of adverse outcomes within TOFA group of treatment might provide precious information on safe patient selection.
Target group:
  • IBD centres with the possibility to retrieve data on UC patients undergoing colectomy and the necessary information in the perioperative period
  • IBD centres who are willing to fill out an electronic clinical research form (eCRF) through REDCap® software for all included patients.
  • IBD centres who are willing to verify themselves if approval by their local ethical committee and informed consent of the patient is mandatory in their jurisdiction for a retrospective non interventional study. If so, the IBD centre will be responsible for the submission to the local ethical committee as well as collection of the informed consent
Results: Article published on the American Journal of Gastroenterology, March 19, 2024. DOI: 10.14309/ajg.0000000000002676

2020

The Efficacy of Post-Operative Prophylaxis with either vedolizumab or ustekinumab for Crohn's Disease

Project leaders:

IBD center at Rabin Medical Center (Petah-Tikva, Israel)
Purpose and outcome: A multicenter retrospective cohort study to assess the efficacy of either vedolizumab or ustekinumab (cases) compared with anti-TNFs (controls) for the prevention of CD recurrence after a curative ileocecal resection.
Results:

 Submission of an abstract to ECCO'21 and a full manuscript thereafter

2019

Prophylactic versus endoscopy-driven treatment of Crohn's postoperative recurrence

Project leaders:
 IBD unit of the University Hospital Ghent
Purpose and outcome: The aim of this study is to compare the incidence of ePOR at short term in CD patients after ileocecal resection with two different strategies: prophylactic early postoperative initiation of medical treatment (“pro-active approach”) vs. treatment driven by postoperative endoscopic findings (“reactive approach”).
Target group:
  • IBD centres which kept track of Crohn’s patients that underwent ileocecal resection over at least the past decade
  • IBD centers who are willing to fill out completely and correctly an electronic clinical research form (eCRF) through REDCap® software for all included patients
  • IBD centers who are willing to verify themselves if approval by their local ethical committee and informed consent of the patient is mandatory in their jurisdiction for a retrospective non interventional study. If so, the IBD center will be responsible for the submission to the local ethical committee as well as collection of the informed consent. As mentioned, the study was already approved by the Ethical Committee of University Hospital Ghent (Belgium) on 05/03/2021
  • IBD centres who are willing to do everything to avoid missing data as much as possible by contacting patients, colleague gastroenterologists, general practitioners and any other physicians in charge of the patient

GlobalSurg | CovidSurg Week

Project leaders:
 NIHR Global Health Research Unit on Global Surgery
Purpose and outcome:
  • To determine the optimal timing of surgery following SARS-CoV-2 infection;
  • Determine assess key global surgical indicators, such as postoperative mortality.
Target group:
  • In order to achieve the above aims, this study will include all patients undergoing surgery
    with a preoperative, postoperative or no SARS-CoV-2 infection.
  • All hospitals are eligible
    to participate, regardless having admitted SARS-CoV-2 infected patients or not.

Prior

Safety and efficacy of combining two biological therapies together or a biological therapy with a new small molecule in patients with IBD and other immune mediated inflammatory diseases

Project leaders:
 Belgian IBD Research and Development group (BIRD)
Purpose and outcome: • To study the efficacy and safety of combining biological treatments together, or with new small molecules in IBD and IMID.
• To identify subgroups of patients who may present safety issues either due to the drugs combinations or patient characteristics  itself (age, comorbidities, previous medical history etc.)
• To study the outcome on extra-intestinal manifestations if any.
• To study the effect of the combination treatment on IBD and IMID disease activity.
Results: Submission of an abstract to ECCO'21 and a full manuscript thereafter

Effectiveness of dose escalation of ustekinumab in Crohn's disease

Project leaders:
 Sheba Medical Center (Ramat Gan, Israel)
Purpose and outcome: In patients losing response to ustekinumab, possible therapeutic options may include shortening of interval between doses and intravenous reinduction. However, there is very little evidence to support the effectiveness of dose-optimisation strategy to manage primary or secondary non-response to ustekinumab. Thus, we are proposing a wide collaborative retrospective study to evaluate the effectiveness of dose escalation strategy with usekinumab in CD.
Results:

Full manuscript: 

Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard‐dose subcutaneous maintenance therapy. Kopylov U, Hanzel J, Liefferinckx C, De Marco D, Imperatore N, Plevris N, Baston‐Rey I, Harris RJ, Truyens M, Domislovic V, Vavricka S, Biemans V, Myers S, Sebastian S, Ben‐Horin S, González Lama Y, Gilletta C,  Shitrit Ariella B-G, Zelinkova Z, Weishof R, Storan D, Zittan E, Farkas K, Molnar T, Franchimont D, Cremer A, Afif W, Castiglione F, Lees C, Barreiro‐de Acosta M, Lobaton T, Doherty G, Krznaric Z, Pierik M, Hoentjen F, Drobne D. AP&T https://doi.org/10.1111/apt.15784

Outcome of pregnancies in female IBD patients treated with vedolizumab (CONCEIVE)

Project leaders:
 University Hospitals of Leuven (Belgium), the Erasmus MC (Rotterdam, The Netherlands), the Shaare Zedek Medical Center (Jerusalem, Israel)
Purpose and outcome: Very few data are available regarding pregnancy outcomes in female patients with IBD treated with vedolizumab. Expanding the existing study initiatives to a European level would certainly provide more data on the safety of vedolizumab in pregnancy and offspring. European research groups and individual IBD centers are invited to collaborate on this topic in a retrospective, multi-center cohort study.
Publications:

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Moens A, van der Woude CJ, Julsgaard M, Humblet E, Sheridan J, Baumgart DC, Gilletta De Saint-Joseph C, Nancey S, Rahier JF, Bossuyt P, Cremer A, Dewit S, Eriksson C, Hoentjen F, Krause T, Louis E, Macken E, Milenkovic Z, Nijs J, Posen A, Van Hootegem A, Van Moerkercke W, Vermeire S, Bar-Gil Shitrit A, Ferrante M. Aliment Pharmacol Ther. 2019 Nov 6. doi: 10.1111/apt.15539

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