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Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease (BioIBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885713
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab and ustekinumab will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patients with treatment
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice, or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice
Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice

No Intervention: healthy control



Primary Outcome Measures :
  1. Identify predictive tissue and blood biomarkers for response to biologic therapies in Crohn´s disease and ulcerative colitis [ Time Frame: 14 weeks ]
    will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio


Secondary Outcome Measures :
  1. Identify non-invasive blood biomarkers of endoscopical inflammation [ Time Frame: 14 weeks ]
    will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio

  2. Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated [ Time Frame: 14 weeks ]
    To achieve this outcome will be used endoscopic response defined in CD patients as a decrease of 50% in SES-CD(78) 14 weeks after starting treatment and defined in UC patients as a decrease ≥1 point in the mayo score (82) 14 weeks after starting treatment

  3. Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple) [ Time Frame: 14 weeks ]
    these samples will be use to reach the outcomes of this study and will be used in future studies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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-TNFα, anti-α4β7 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-TNFα, anti-α4β7 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885713


Contacts
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Contact: Ana Garre 913093911 anagarre.laprincesa@gmail.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Publications:

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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03885713    
Other Study ID Numbers: GIS-2018-BioIBD
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
inflammatory bowel diseases
Crohn Disease
Ulcerative Colitis
Infliximab
Adalimumab
Golimumab
Vedolizumab
Ustekinumab
Anti-TNF
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Adalimumab
Infliximab
Ustekinumab
Vedolizumab
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents