A Phase 4 interventional study of Anti-TNF: Infliximab (Infusion) and Anti-TNF discontinuation: Physiological saline solution in Crohn's Disease, Inflammatory Bowel Disease and Ulcerative Colitis, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Phase 4, Interventional, and Treatment
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
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:
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).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 139 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)
Biological: Anti-TNF: Infliximab (Infusion) · Biological: Anti-TNF:Adalimumab (Subcutaneus)
Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)
Drug: Anti-TNF discontinuation: Physiological saline solution
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Time frame: Change at 12 months.
Clinical activity assessment
On Crohn´s Disease: Measure by Crohn´s Disease Activity Index (CDAI)
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
On Crohn´s Disease: Measure by Simplified endoscopic activity score for Crohn´s disease (SES-CD).
Time frame: 12 Months. On the Month 0, month 12 or relapse
Radiologic activity assessment
Measure by absence of contrast enhancement, edema or presence of ulcers
Time frame: 12 Months. Month 0, month 12 or relapse
Quality of life assessment
Measure by the Inflammatory Bowel Disease Questionnaire (IBDQ-9)
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
The Work productivity and activity assessment
Measure by "Spanish Work Productivity and Activity Impairment Questionnaire".This questionnaire assessments the sum of work time missed because IBD and impairment while working yields the overall work impairment (productivity loss) score. Scores are expressed as percentages of impairment/productivity loss, with higher scores indicating greater impairment.
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Clinical activity assessment
On the Ulcerative Colitis disease: Measure by Mayo Scoring System
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
On the Ulcerative Colitis disease: Measure by Mayo endoscopic score.
Time frame: 12 Months. On the Month 0, month 12 or relapse
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa