A Phase 4 interventional study of Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Completed at 21 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Phase 4, Interventional, and Treatment
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab, ustekinumab and tofacitinib 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.
Background
IBD, including CD and UC, is a chronic disorder of unknown etiology that involves a pathological response of the immune system, resulting in chronic inflammation of the gastrointestinal tract. IBD generally affects young patients, being a highly disabling disease. Unfortunately IBD has no current treatment, so the therapeutic goal is to keep the inflammatory process under control in order to prevent the onset of symptoms and the development of further complications.
The complexity and costs associated with the treatment of IBD make it a very relevant disease. Specifically in the USA, where it is one of the five diseases with the greatest social burden, with an annual cost of 1,700 million dollars for health services. In Europe, the annual costs (direct and indirect) associated with IBD exceed 25,000 million euros. Together, this highlights the strategic importance of IBD for society, including both patients and the health system.
IBD prevalence is high, affecting more than 1.6 million inhabitants in the US and more than 2.2 million in Europe. On the other hand, its incidence varies widely depending on the different countries. Nevertheless, in a generalized manner, it is increasing rapidly, probably due to the "westernization" of lifestyles. Indeed, a large multicenter study leaded by the host institution suggests that the current incidence is greater than previously described.
In addition, the cost associated with IBD diagnosis and treatment is increasing over time, either because of the costs associated with the treatment itself or due to the greater complexity of the diagnostic tests and tools to which these patients are subjected.
Despite the increasingly frequent use of immunosuppressant drugs, the need for surgery due to IBD has not changed substantially in recent decades. It has been suggested that early initiation of treatment with immunosuppressants and biologics to induce remission would prevent the onset of complications of the disease. However, this widely applied strategy would lead to overtreatment of patients who would have had a benign course of the disease. On the other hand, the current treatment strategy is similar in almost all patients with IBD: it starts, in general, with the less aggressive drugs, progressively moving to more potent therapies when previous treatments have failed. In this way, the window of opportunity to prevent complications in more complex patients is often lost. Thus, because there are no prognostic factors that have proven useful in clinical practice, the selection of a treatment for each patient remains empirical, adapted according to clinical evolution and difficulties of each case.
Anti-TNFα drugs have been shown to be effective for induction of remission and maintenance thereof in patients with IBD. In 2014, the use of vedolizumab was approved, both for CD and UC, whose therapeutic targets are α4β7 integrins. In 2016, ustekinumab, directed against the p40 subunit shared by interleukins 12 and 23, was approved in patients with CD, thus increasing the therapeutic arsenal against IBD. All these biologic drugs have a high cost, so they pose a great economic burden for health systems. However, approximately only one third of patients will achieve remission. At present, the medical community does not have reliable criteria for selecting which patients will benefit from any of the above-mentioned drugs. Thus, the variables (epidemiological, clinical, analytical, etc.) usually used to predict patients' response to biological therapy have shown little utility. Therefore, it is a priority in the study of IBD the identification of those molecular and cellular pathways involved in the onset of IBD in each patient, in order to make a more rational use of resources. Achieving that goal will allow us to indicate the most appropriate treatment to each individual, hence avoiding administering drugs to patients who will not respond (which implies an inadequate use of resources and an unjustified risk of adverse effects).
The identification of biomarkers with capacity to predict clinical response to biologic drugs is, therefore, an area of great interest. In this context, "omic" techniques allow massive searches at various levels, including DNA (genomics) and its modifications (epigenome), RNA (transcriptome), proteins (proteome), bacterial composition (microbiome), etc. This project aims to deepen this aspect through the use of 2 massive last-generation approaches that will identify the signaling routes (proteomics) and the immune cell subsets (mass cytometry) involved in the response to biologic drugs. This will ultimately lead to the identification, in an unbiased manner, of novel predictive biomarkers for response to biologic therapies in IBD.
Study population
Definitions
Endoscopic activity:
Endoscopic response (main endpoint):
Endoscopic remission:
Clinical activity:
Sample size
The sample size for the laboratory analyses will be 30 in each of the subgroups of patients: 1) CD treated with anti-TNFα drugs; 2) CD treated with vedolizumab; 3) CD treated with ustekinumab; 4) UC treated with anti-TNFα; 5) UC treated with vedolizumab; 6) UC treated with tofacitinib. Since the total number of patients is 180, the inclusion for each of the 17 participating centers will be approximately 9 patients, a perfectly viable figure in the allocated timeframe. It is estimated that the percentage of endoscopic response (primary endpoint) is 30% so in each subgroup there will be 10 responding patients and 20 patients with treatment failure, an adequate number for the evaluation of biomarkers predictors of response. In addition, 30 healthy controls will be included to compare the obtained results in the IBD patients.
Development of the study
The present study is organized in 3 visits: visit 1, prior to initiating the treatment; visit 2, at 14 weeks after starting treatment; and visit end of study. The investigators will use their proved expertise in previous clinical trials to coordinate and monitor all the research centers using the online AEG-RedCap platform. Data collection forms will be provided to all the centers prior to start the study. The overall duration of the study is estimated at 3 years (20 months of inclusion + 4 months of follow-up + 12 months for analysis).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 180 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1: Patients with IBD
Inclusion Criteria:
Exclusion Criteria:
Group 2: patients without IBD
Inclusion Criteria:
Exclusion Criteria:
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)) per clinical practice, or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)) per clinical practice or tofacitinib (oral 5mg bid oral) per clinical practice
Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib
Patients without treatment
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)) 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)) per clinical practice or tofacitinib (oral 5mg bid)
Identify predictive tissue and blood biomarkers for response to biologic therapies and tofacitinib in Crohn´s disease and ulcerative colitis
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio
Time frame: 14 weeks
Identify non-invasive blood biomarkers of endoscopical inflammation
will be calculated for each of the selected biomarkers: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio
Time frame: 14 weeks
Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated
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
Time frame: 14 weeks
Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple)
these samples will be use to reach the outcomes of this study and will be used in future studies
Time frame: 14 weeks
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa