ClinCom
12June2019

Report from IIS Award Winner 2019: Erwin Dreesen

Erwin Dreesen, ECCO Member

E.Dreesen
Erwin Dreesen
© ECCO

Targeting endoscopic outcomes through combined pharmacokinetic and pharmacodynamic monitoring of infliximab therapy in patients with Crohn’s Disease

In the multicentre, randomised, controlled TAILORIX trial, it was not possible to show a benefit of infliximab dose escalation based on a combination of pharmacokinetic monitoring (i.e. serum concentrations of infliximab) and pharmacodynamic monitoring (i.e. symptoms and biomarker) as compared to dose escalation based on symptoms alone [1]. However, infliximab dose escalations only commenced after the induction regimen. In the current post hoc pharmacokinetic–pharmacodynamic analysis of TAILORIX, we examined the roles of pharmacokinetic and pharmacodynamic monitoring during infliximab induction and maintenance therapy for targeting endoscopic outcomes [2].

Posted in ECCO News, Volume 14, Issue 2, Committee News, ClinCom

12June2019

Report from IIS Award Winner 2019: Amit Assa

Amit Assa, P-ECCO Member

Proactive adalimumab trough measurement is associated with improved treatment outcomes in children with Crohn’s Disease: The PAILOT randomised controlled trial

Amit Assa 2019
Amit Assa
© ECCO

Loss of response (LOR) during anti-TNF treatment for Crohn's Disease (CD) is commonly approached through the measurement of trough concentration (TC) and anti-drug antibodies, with subsequent modification of treatment (reactive therapeutic drug measurement, TDM). It is appealing to speculate that tailored treatment based on routine TC and antibody measurements (proactive TDM) may assist in sustaining adequate drug levels and thus in improving efficacy and preventing the evolution of anti-drug antibodies. Nevertheless, two randomised controlled trials, the TAXIT [1] and the TAILORIX [2], have failed to demonstrate superiority of level-based over clinically based adjustment of infliximab treatment. To date, there are no prospective studies comparing proactive vs reactive TDM in paediatric CD nor are there any studies evaluating the proactive approach among adults or children treated with adalimumab. Hence, we aimed to investigate the effect of proactive drug monitoring-based treatment, in comparison with clinical and biologic-based monitoring of disease activity in children with CD treated with adalimumab.

Posted in ECCO News, Volume 14, Issue 2, Committee News, ClinCom

30April2019

Y-ECCO/ClinCom call for Y-ECCO Small Research Survey Proposals

Gianluca Pellino & Mark Samaan, Y-ECCO Members

Gianluca Pellino 2019Gianluca Pellino 
© ECCO
Mark Samaan 2019Mark Samaan 
© ECCO

The call for research proposals returns with opportunities for Y-ECCO Members to propose and perform a brief, focused research project with ClinCom/Y-ECCO guidance and ECCO support.

Posted in ECCO News, ClinCom, Volume 14, Issue 1, Y-ECCO

30April2019

COllaborative Network For Exceptionally Rare case reports (ECCO CONFER)

Uri Kopylov, Head of CONFER Steering Committee and ClinCom Member

Uri Kopylov
Uri Kopylov
© ECCO

Call for similar cases now open!

 

Rare manifestations of Inflammatory Bowel Diseases (IBD) and rare adverse effects of IBD medications are significantly underreported in the current literature. Case reports are becoming increasingly difficult to publish, and the motivation to publish them is diminishing. Moreover, accumulation of data from such reports usually does not result in a better understanding of these events. In the last five years, ECCO has created a project that aims to shed light on rare disease manifestations and treatment-related events. 

Posted in ECCO News, ECCO'19, Committee News, Volume 14, Issue 1, Congress News, ClinCom

30April2019

Report on the 3rd School for Clinical Trialists at ECCO'19

John Mansfield, former ClinCom Member

John Mansfield John Mansfield
© ECCO

The ECCO Clinical Research Committee (ClinCom) organises The School for Clinical Trialists as a half-day workshop at the ECCO Congress. This year the topics covered were: The Evolution of Trial Design and How to Optimise Recruitment to Clinical Trials. 

Posted in ECCO News, Committee News, Volume 14, Issue 1, ClinCom

30April2019

News on ClinCom Structure

Krisztina Gecse, ClinCom Chair

Krisztina GecseKrisztina Gecse
© ECCO

It was our pleasure to welcome three new members, Laurent Beaugerie, Peter Bossuyt and Shaji Sebastian, onto the Clinical Research Committee of ECCO at the ECCO’19 Copenhagen Congress.

Posted in ECCO News, ECCO'19, Committee News, Volume 14, Issue 1, Congress News, ClinCom

11December2018

ClinCom’s School for Clinical Trialists programme for ECCO Congress 2019

John Mansfield, ClinCom Member

John Mansfield John Mansfield
© ECCO

ClinCom is pleased to present the 3rd School for Clinical Trialists: Clinical Trial Evolution and Recruitment in IBD, on Wednesday, March 6, 2019, 08:00-11:30.

ClinCom exists as an ECCO Committee to further develop and encourage clinical trial activity in IBD within ECCO. This, the 3rd School for Clinical Trialists, will give clinicians, nurses, research coordinators and all those interested in clinical trials a state-of-the-art view of the evolution of clinical trial design and practical aspects of the key problem of how to optimise trial recruitment.

Posted in ECCO News, Committee News, ClinCom, Volume 13, Issue 4

04October2018

Call: Y-ECCO Small Research Proposals

John Nik Ding, Y-ECCO Member

The call for research proposals returns with opportunities for Y-ECCO Members to propose and perform a brief, focused research project with ClinCom/Y-ECCO guidance and ECCO support.

Posted in ECCO News, ClinCom, Volume 13, Issue 3, Y-ECCO

04October2018

Starting an investigator-initiated study with the help of ClinCom

Javier Gisbert, ClinCom Member

Javier GisbertJavier Gisbert
© ECCO

An interview with María Chaparro

Javier P. Gisbert: Investigator-initiated studies (IIS) are clinical studies initiated and managed by non-pharmaceutical company researchers, including individual investigators, institutions, collaborative study groups and cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations. Your group at La Princesa Hospital (Madrid, Spain) has remarkable experience in this type of study. What attracts you most to such studies?

Posted in ECCO News, Committee News, ClinCom, Volume 13, Issue 3

08June2018

ECCO'18 IIS Award Winner: Nicholas Kennedy

The PANTS study

04 02 Portrait
Nicholas Kennedy
© ECCO

 

Use of the anti-TNF alpha monoclonal antibodies infliximab and adalimumab has transformed the management of patients with refractory Crohn’s Disease. However, clinicians and patients are all too aware that anti-TNF treatment failure is common: 10%–40% of patients fail to respond to induction therapy (referred to as primary non-response: PNR), up to 40% of patients suffer secondary loss of response in the first year of therapy and approximately 10% suffer an adverse drug reaction that curtails treatment.

Posted in ECCO News, Committee News, ClinCom, Volume 13, Issue 2