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

February 28, 2023 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anti-TNF
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)
Biological: 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)
Biological: 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).
Placebo Comparator: Anti-TNF discontinuation (Placebo)
Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)
Drug: Anti-TNF discontinuation: Physiological saline solution
Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Time Frame: Change at 12 months.
Change at 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical activity assessment
Time Frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
On Crohn´s Disease: Measure by Crohn´s Disease Activity Index (CDAI)
Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
Time Frame: 12 Months. On the Month 0, month 12 or relapse
On Crohn´s Disease: Measure by Simplified endoscopic activity score for Crohn´s disease (SES-CD).
12 Months. On the Month 0, month 12 or relapse
Radiologic activity assessment
Time Frame: 12 Months. Month 0, month 12 or relapse
Measure by absence of contrast enhancement, edema or presence of ulcers
12 Months. Month 0, month 12 or relapse
Quality of life assessment
Time Frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Measure by the Inflammatory Bowel Disease Questionnaire (IBDQ-9)
Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
The Work productivity and activity assessment
Time Frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
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.
Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Clinical activity assessment
Time Frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
On the Ulcerative Colitis disease: Measure by Mayo Scoring System
Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
Time Frame: 12 Months. On the Month 0, month 12 or relapse
On the Ulcerative Colitis disease: Measure by Mayo endoscopic score.
12 Months. On the Month 0, month 12 or relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIS-SUSANTI-TNF-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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