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NCT03885713CompletedPhase 4

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

Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Source: ClinicalTrials.gov · Last updated 17 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
180 (actual)
First submitted
4 Mar 2019
Start date
10 Sept 2019
Primary completion date
31 Dec 2024
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
NCT number
NCT03885713

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 180
  • From 10 Sept 2019 to the primary completion date, 31 Dec 2024
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Alcohol or drug abuse.
  • Abdominal surgery in the last 6 months.
  • 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).
  • Alcohol or drug abuse.

Other illness

  • 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.
  • Active infection with hepatitis B, C or HIV virus.
  • Advanced chronic disease or any other pathology that prevents the follow-up of the protocol of this study.
  • Active infection with hepatitis B, C or HIV virus.

Age

  • Under 18 years old.
  • Under 18 years old.

Other

  • Pregnancy or lactation.
  • Ostomy.
  • Colectomy in patients with UC.
  • Indication of biologic treatment for a cause other than IBD.
  • Indication of biologic treatment to prevent postoperative recurrence in CD.
  • Refusal to give consent for participation in the study.
    • Group 2: patients without IBD
  • Pregnancy or lactation.
  • 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.

Who the study is looking for

  • 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).
  • \- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ileocolonoscopy is performed due to the normal clinical practice.

Criteria the registry did not label

  • Group 1: Patients with IBD

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital General Universitario de Alicante
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AlicanteSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Universitario Donostia
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Donostia / San SebastianSpainUnknown status
Hospital Universitario de Fuenlabrada
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FuenlabradaSpainUnknown status
Hospital de Galdakao
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GaldakaoSpainUnknown status
Hospital Universitario Dr. Josep Trueta
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GironaSpainUnknown status
Hospital Juan Ramon Jimenez
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HuelvaSpainUnknown status
Hospital San Jorge
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HuescaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario de Navarra
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PamplonaSpainUnknown status
Hospital Universitario Parc Tauli
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SabadellSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Clínico de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Público General de Tomelloso
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TomellosoSpainUnknown status
Hospital Universitario de Torrejon
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Torrejón de ArdozSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
Hospital Rio Hortega
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ValladolidSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.