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

NCT ID: NCT02994836

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2022-12-31

Brief 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

Detailed Description

A multicentre prospective randomized trial.

Hypothesis:

The discontinuation of anti-TNF treatment in inflammatory bowel disease (IBD) patients in clinical remission is associated with an increased risk of recurrence compared with maintaining such treatment.

Main objective:

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

Secondary objectives:

To compare treatment discontinuation vs. treatment continuation of anti-TNF agents in patients with Crohn´s disease or ulcerative colitis in terms of:

1. remission (relapse-free) time,

2. phenotype changes with both strategies

3. mucosal healing,

4. radiologic healing

5. impact on quality of life and productivity

6. safety

7. to identify relapse predictive factors.

8. To identify relapse predictive factors after anti-TNF drug discontinuation

9. Determining the profile of serum cytokines in patients with both strategies, depending on drug exposure and if maintained clinical remission or relapse.

Planned number of subject to be included: 194

The participation of at 50 hospitals in Spain with an inclusion of about 5 patients per hospital is required..

Case report Form was designed on REDCap (a free, secure, web-based application designed to support data capture for research studies).

Conditions

Crohn's Disease; Inflammatory Bowel Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Anti-TNF

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)

Group Type: ACTIVE_COMPARATOR

Anti-TNF: Infliximab (Infusion)

Intervention Type: BIOLOGICAL

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Anti-TNF:Adalimumab (Subcutaneus)

Intervention Type: BIOLOGICAL

Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Anti-TNF discontinuation (Placebo)

Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)

Group Type: PLACEBO_COMPARATOR

Anti-TNF discontinuation: Physiological saline solution

Intervention Type: DRUG

Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Anti-TNF discontinuation: Physiological saline solution

Intervention Type: DRUG

Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Interventions

Anti-TNF: Infliximab (Infusion)

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Intervention Type: BIOLOGICAL

Anti-TNF discontinuation: Physiological saline solution

Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Intervention Type: DRUG

Anti-TNF:Adalimumab (Subcutaneus)

Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Intervention Type: BIOLOGICAL

Anti-TNF discontinuation: Physiological saline solution

Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier MD Perez Gisbert, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Locations

Hospital Universitario de La Princesa

Madrid, , Spain

Countries

Spain

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Other Identifiers

GIS-SUSANTI-TNF-2015

Identifier Type: -

Identifier Source: org_study_id