Anti-TNF discontinuation in patients with inflammatory bowel disease

Phase 1

• Conditions: Inflammatory bowel disease; MedDRA version: 19.0Level: LLTClassification code 10021973Term: Inflammatory bowel disease NOSSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001410-10-ES
• Lead Sponsor: Fundación de Investigación Biomédica Hospital Universitario de la Princesa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-17
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

?Patients diagnosed with IBD (Crohn's disease or ulcerative colitis)
? Patients diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.
? Patients older than 18 years.
? Have received treatment with an anti-TNF drug to induce clinical remission of IBD by clinical practice.
? Being the first anti-TNF drug received and the first course of the drug.
? In the case of patients with Crohn's disease the indication treatment with anti-TNF it must have been for luminal involvement (no perianal).
? Are currently in clinical remission.
? The pretreatment period with anti-TNF must have been at least 1 year (and with stable doses during the last year).
? The clinical remission period it must have been at least 6 months.
? At the time of inclusion, the patient should be receiving concomitant immunosuppressants (thiopurine or methotrexate) to anti-TNF treatment, and must have received these immunosuppressive drugs at stable doses for at least the last 3 months.
? In patients with Crohn's disease or ulcerative colitis disease, at baseline colonoscopy (made up to 30 days before inclusion) should not be significant injuries.
? In the case of patients with Crohn's ileal or ileocolic disease, in magnetic resonance whole should not be significant injuries.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

? Age less than 18 years.
? Patients who have been treated with anti-TNF for other indication than the IBD.
? Patients who, at some point, have received an anti-TNF drug dose higher than the standard, intensified; that is, more than 5 mg / kg / 8 weeks, in the case of infliximab, or 40 mg / 2 weeks, in the case of adalimumab.
? Patients with Crohn's disease in which the indication for treatment with anti-TNF has been the perianal involvement (or luminal and perianal both); or showing active perianal disease at the time of inclusion.
? Patients who have previously discontinued treatment with anti-TNF and subsequently been restarted.
? Patients who have previously received it another anti-TNF drug.
? Patients with IBD who began treatment with anti-TNF being in clinical remission.
? Patients who are not receiving concomitant treatment with immunosuppressants (thiopurine or methotrexate) at the moment (and in the previous 3 months).
? Patients undergoing bowel resection surgery; therefore, patients who began anti-TNF therapy to prevent or treat postoperative recurrence in Crohn's disease will be excluded.
? Presence of significant endoscopic or radiological lesions
? Advanced chronic illness or any other condition that prevents the patient from coming to the clinic for monitoring or follow-up.
? Patients who are pregnant, breastfeeding or intending to become pregnant during the course of the study.
? Refusal to give consent for participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified