The primary objective of the PIBD-NET inception cohort is to search for factors predictive for outcome, specific severe adverse events (SAEs) and for predictors of response or non-response to therapy. The secondary objective is the identification of…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of the study is the identification of factors predictive for
outcome, specific severe adverse events (SAEs) and for predictors of response
or non-response to therapy and the identification of rare complications of
disease or treatment in PIBD.
Secondary outcome
Not applicable
Background summary
The incidence of paediatric onset Inflammatory Bowel Diseases (PIBD) has risen
dramatically in recent decades. Compared to adult forms, PIBD reflects a more
severe disease. Paediatric patients more often requiring aggressive treatment
with immunomodulators. Thereby children are exposed to a life-long risk of both
serious disease and treatment-related adverse events, such as infections and
malignancies. In addition, the risk profile for severe adverse events might
differ between children/adolescents and adults with IBD. Therefore, there is an
urgent need to generate a prospective large long term real world inception
cohort designed to analyze effectiveness and safety signals and correlate them
to individual risk factors in well phenotyped patients. Many side effects and
complications are rare and so to identify and study these in addition to the
inception cohort there is a requirement to establish a process for identifying
these complications using a European wide paediatric IBD safety monitoring
registry, next to the inception cohort.
Study objective
The primary objective of the PIBD-NET inception cohort is to search for factors
predictive for outcome, specific severe adverse events (SAEs) and for
predictors of response or non-response to therapy.
The secondary objective is the identification of rare complications of disease
or treatment in PIBD.
Study design
An observational registry including a subcohort of patients with biobanking
will be set up and collection of safety signalling on a wide scale will be
performed.
A robust and highly secured prospective multicentre long term database tool
(PIBD-cloud) for PIBD will be created in collaboration with a highly
experienced IT small/medium-size enterprise (SME) (WP6). Newly diagnosed
patients will be identified and carefully phenotyped. Patients will be closely
monitored for disease progression during follow up.
Next to this, a pan-European safety registry of rare complications of drugs and
the disease will be created.
Study burden and risks
Both the inception cohort study and the safety registry do not bring any risks
for the patients. The burden is considered minimal.
Rue de l'école de Medecine 12
Parijs 75270
NL
Rue de l'école de Medecine 12
Parijs 75270
NL
Listed location countries
Age
Inclusion criteria
Children with newly diagnosed IBD (age 0-18 years)
Exclusion criteria
• Insufficient knowledge of national language
• Informed consent of patient or parents has not been obtained
• Severe co-morbidity
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57248.078.16 |