EUCTR2018-002925-47-ES
Active, Not Recruiting
Phase 1
Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches
Fundación de Investigación Biomédica del Hospital Universitario de La Princesa0 sites180 target enrollmentNovember 16, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación de Investigación Biomédica del Hospital Universitario de La Princesa
- Enrollment
- 180
- Status
- Active, Not Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1: Patients with IBD
- •\- 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.
- •Group 2: patients without IBD
- •\- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ilecolonoscopy is performed due to the normal clinical practice.
Exclusion Criteria
- •Group 1: Patients with IBD
- •\- 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.
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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