GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Treatments: Adalimumab; Infliximab; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.

• Patients older than 18 years.

• 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 clinical remission period with the drug at non-intensified dose it must have been at least 6 months.

The administration of ≥10 mg/kg/8 weeks or 5 mg / kg / ≤ 4 weeks, in the case of infliximab, and 40 mg / week, in the case of adalimumab, is considered an intensified dose.

• 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 3 months prior to the screening visit) 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.(made up to 3 months prior to the screening visit)

Exclusion Criteria:

• Age less than 18 years.

• Patients who have been treated with anti-TNF for other indication than the IBD.

• 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 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.