Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease

NCT03885713 | Completed Phase 4

• 1 other identifier: GIS-2018-BioIBD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 21

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, 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

inflammatory bowel diseases; Crohn Disease; Ulcerative Colitis; Infliximab; Adalimumab; Golimumab; Vedolizumab; Ustekinumab; Anti-TNF; Tofacitinib

Outcome Measures

Primary Outcomes (1)

• 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

  14 weeks

Secondary Outcomes (3)

• Identify non-invasive blood biomarkers of endoscopical inflammation

  14 weeks

• Evaluate the effect of the treatment on the immune subsets and study the signaling pathways specifically modulated

  14 weeks

• Generate a collection of biological simple (Blood sample, urine sample, stool sample, biopsy simple)

  14 weeks

Study Arms (2)

Patients with treatment

ACTIVE COMPARATOR

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

healthy control

NO INTERVENTION

Patients without treatment

Interventions

Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib BIOLOGICAL

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)

Patients with treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-TNFα, anti-α4β7, 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).

You may not qualify if:

• 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-TNFα, anti-α4β7, anti-p40 or JAK inhibitor).
• Refusal to give consent for participation in the study.
• Group 2: patients without IBD
• \- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ileocolonoscopy is performed due to the normal clinical practice.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (21)

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Location

Hospital Universitario Parc Taulí

Sabadell, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Público General de Tomelloso

Tomelloso, Ciudad Real, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Donostia, Spain

Location

Hospital Universitario Dr. Josep Trueta

Girona, Gerona, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, Huelva, Spain

Location

Hospital San Jorge

Huesca, Huesca, Spain

Location

Hospital Clínico de Santiago

Santiago de Compostela, La Coruña, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Location

Hospital Rio Hortega

Valladolid, Valladolid, 47012, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Location

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Location

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; Adalimumab; golimumab; vedolizumab; Ustekinumab; tofacitinib

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Javier P Gisbert

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 22, 2019
• Study Start: September 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

ES (21)