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: 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
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).
Hospital Universitario de La Princesa
Madrid, Spain
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
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Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
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