Back to resultsGIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )
Primary Purpose
Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Anti-TNF: Infliximab (Infusion)
Anti-TNF discontinuation: Physiological saline solution
Anti-TNF:Adalimumab (Subcutaneus)
Anti-TNF discontinuation: Physiological saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Inflammatory bowel disease, Anti-TNF discontinuation, Ulcerative colitis
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.
Sites / Locations
- Hospital Universitario de La Princesa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Anti-TNF
Anti-TNF discontinuation (Placebo)
Arm Description
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)
Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)
Outcomes
Primary Outcome Measures
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Secondary Outcome Measures
Clinical activity assessment
On Crohn´s Disease: Measure by Crohn´s Disease Activity Index (CDAI)
Endoscopic activity assessment
On Crohn´s Disease: Measure by Simplified endoscopic activity score for Crohn´s disease (SES-CD).
Radiologic activity assessment
Measure by absence of contrast enhancement, edema or presence of ulcers
Quality of life assessment
Measure by the Inflammatory Bowel Disease Questionnaire (IBDQ-9)
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.
Clinical activity assessment
On the Ulcerative Colitis disease: Measure by Mayo Scoring System
Endoscopic activity assessment
On the Ulcerative Colitis disease: Measure by Mayo endoscopic score.
Full Information
NCT ID
NCT02994836
First Posted
October 24, 2016
Last Updated
February 28, 2023
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1. Study Identification
Unique Protocol Identification Number
NCT02994836
Brief Title
GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )
Official Title
Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
remission (relapse-free) time,
phenotype changes with both strategies
mucosal healing,
radiologic healing
impact on quality of life and productivity
safety
to identify relapse predictive factors.
To identify relapse predictive factors after anti-TNF drug discontinuation
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Keywords
Crohn's Disease, Inflammatory bowel disease, Anti-TNF discontinuation, Ulcerative colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-TNF
Arm Type
Active Comparator
Arm Description
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)
Arm Title
Anti-TNF discontinuation (Placebo)
Arm Type
Placebo Comparator
Arm Description
Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)
Intervention Type
Biological
Intervention Name(s)
Anti-TNF: Infliximab (Infusion)
Intervention Description
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Intervention Type
Drug
Intervention Name(s)
Anti-TNF discontinuation: Physiological saline solution
Intervention Description
Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Intervention Type
Biological
Intervention Name(s)
Anti-TNF:Adalimumab (Subcutaneus)
Intervention Description
Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
Intervention Type
Drug
Intervention Name(s)
Anti-TNF discontinuation: Physiological saline solution
Intervention Description
Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
Primary Outcome Measure Information:
Title
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Time Frame
Change at 12 months.
Secondary Outcome Measure Information:
Title
Clinical activity assessment
Description
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
Title
Endoscopic activity assessment
Description
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
Title
Radiologic activity assessment
Description
Measure by absence of contrast enhancement, edema or presence of ulcers
Time Frame
12 Months. Month 0, month 12 or relapse
Title
Quality of life assessment
Description
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
Title
The Work productivity and activity assessment
Description
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
Title
Clinical activity assessment
Description
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
Title
Endoscopic activity assessment
Description
On the Ulcerative Colitis disease: Measure by Mayo endoscopic score.
Time Frame
12 Months. On the Month 0, month 12 or relapse
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier MD Perez Gisbert, PhD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
12. IPD Sharing Statement
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GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )
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