Inflammatory bowel disease MedDRA version: 19.0 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS System Organ Class: 100000004856
Conditions
Interventions
Pharmaceutical Form: Infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Pharmaceutical
Sponsors
Fundación de Investigación Biomédica Hospital Universitario de la Princesa
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Objective: To compare treatment discontinuation vs. treatment continuation of anti-TNF agents in patients with Crohn?s disease or ulcerative colitis in terms of: a) remission (relapse-free) time, b) phenotype changes with both strategies c) mucosal healing, d) radiologic healing e) impact on quality of life and productivity f) safety g) to identify relapse predictive factors. h) To identify relapse predictive factors after anti-TNF drug discontinuation i) Determining the profile of serum cytokines in patients with both strategies, depending on drug exposure and if maintained clinical remission or relapse.;Primary end point(s): Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).;Timepoint(s) of evaluation of this end point: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Clinical activity assessment * Endoscopic activity assessment * Radiologic activity assessment * Quality of life assessment * Work productivity and activity assessment;Timepoint(s) of evaluation of this end point: * Clinical activity assessment - Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12 * Endoscopic activity assessment - Month 0, month 12 or relapse * Radiologic activity assessment - Month 0, month 12 or relapse * Quality of life assessment - Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12 * Work productivity and activity assessment - Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12 | — |
Countries
Spain
Contacts
Public ContactEva Rodríguez
Fundación de Investigación Biomédica Hospital Universitario de la Princesa
Outcome results
None listed