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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital Universitario de Fuenlabrada Coordinator of this site? Confirm its status | Fuenlabrada | Spain | Unknown status |
| Hospital de Galdakao Coordinator of this site? Confirm its status | Galdakao | Spain | Unknown status |
| Hospital Universitario Dr. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital San Jorge Coordinator of this site? Confirm its status | Huesca | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Público General de Tomelloso Coordinator of this site? Confirm its status | Tomelloso | Spain | Unknown status |
| Hospital Universitario de Torrejon Coordinator of this site? Confirm its status | Torrejón de Ardoz | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.