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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03885713
Date of registration: 04/03/2019
Prospective Registration: Yes
Primary sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Public title: Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease BioIBD
Scientific title: Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches
Date of first enrolment: September 10, 2019
Target sample size: 180
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03885713
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Spain
Contacts
Name:     Ana Garre
Address: 
Telephone: 913093911
Email: anagarre.laprincesa@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

Group 1: Patients with IBD

Inclusion Criteria:

- Over 18 years.

- Diagnosis of IBD according to the criteria of the European Crohns and Colitis
Organization (ECCO).

- Have indication of treatment with a biologic drug.

- Be the first received biologic drug with a given mechanism of action (anti-TNFa,
anti-a4ß7 or anti-p40).

- Have endoscopic activity of IBD within 1 month of starting the biologic treatment (see
definitions section: SES-CD = 3 in CD and endoscopic sub-index of May = 2 in UC).

- In the case of CD, receive the biologic treatment by luminal activity (not perianal).

- Previous treatments (including corticosteroids and immunosuppressants) are allowed
provided that they have been stable for the last 3 months prior to beginning treatment
with biologics and that they are maintained at a stable dose for the duration of the
study.

Exclusion Criteria:

- Under 18 years old.

- Having an immune-mediated disease other than IBD at the baseline visit.

- Having a neoplasm or an active infection at the time of the baseline visit.

- Pregnancy or lactation.

- Alcohol or drug abuse.

- Ostomy.

- Abdominal surgery in the last 6 months.

- Colectomy in patients with UC.

- Active infection with hepatitis B, C or HIV virus.

- Indication of biologic treatment for a cause other than IBD.

- Indication of biologic treatment to prevent postoperative recurrence in CD.

- Have previously received a biologic drug with the same mechanism of action of the drug
indicated by your doctor (anti-TNFa, anti-a4ß7 or anti-p40).

- Refusal to give consent for participation in the study.

Group 2: patients without IBD

Inclusion Criteria:

- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune
diseases, where a ileocolonoscopy is performed due to the normal clinical practice.

Exclusion Criteria:

- Under 18 years old.

- Advanced chronic disease or any other pathology that prevents the follow-up of the
protocol of this study.

- Pregnancy or lactation.

- Active infection with hepatitis B, C or HIV virus.

- Alcohol or drug abuse.

- Finding of macroscopic alterations during the ileocolonoscopy, or finding of relevant
inflammatory alterations in the biopsies obtained during the ileocolonoscopy.

- Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs
that alter the immune system.

- Refusal to give consent for participation in the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Inflammatory Bowel Diseases
Ulcerative Colitis
Intervention(s)
Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab
Primary Outcome(s)
Identify predictive tissue and blood biomarkers for response to biologic therapies in Crohn´s disease and ulcerative colitis [Time Frame: 14 weeks]
Secondary Outcome(s)
Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated [Time Frame: 14 weeks]
Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple) [Time Frame: 14 weeks]
Identify non-invasive blood biomarkers of endoscopical inflammation [Time Frame: 14 weeks]
Secondary ID(s)
GIS-2018-BioIBD
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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