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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 November 2023 |
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Main ID: |
NCT03885713 |
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Date of registration:
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04/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
BioIBD |
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Scientific title:
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Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches |
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Date of first enrolment:
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September 10, 2019 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03885713 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Diana Acosta |
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Address:
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Telephone:
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913093911 |
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Email:
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diana.acosta.hlp@gmail.com |
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Affiliation:
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Name:
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Javier P Gisbert |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
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Key inclusion & exclusion criteria
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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 or tofacitinib.
- Be the first received drug with a given mechanism of action (anti-TNFa, anti-a4ß7,
anti-p40 or Janus kinase (JAK) inhibitor).
- 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).
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 drug with the same mechanism of action of the drug
indicated by your doctor (anti-TNFa, anti-a4ß7, anti-p40 or JAK inhibitor).
- 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.
- Refusal to give consent for participation in the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Inflammatory Bowel Diseases
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Ulcerative Colitis
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Intervention(s)
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Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib
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Primary Outcome(s)
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Identify predictive tissue and blood biomarkers for response to biologic therapies and tofacitinib in Crohn´s disease and ulcerative colitis
[Time Frame: 14 weeks]
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Secondary Outcome(s)
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Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple)
[Time Frame: 14 weeks]
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Identify non-invasive blood biomarkers of endoscopical inflammation
[Time Frame: 14 weeks]
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Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated
[Time Frame: 14 weeks]
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Secondary ID(s)
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GIS-2018-BioIBD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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