Possibia

2994836

Last Update Posted: 2023-03-01

Recruiting has ended

All Genders

accepted

18 Years +

139 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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

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).

Eligibility

Relevant conditions:

Crohn's Disease

Inflammatory Bowel Disease

Ulcerative Colitis

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

No valid contacts available

Data sourced from ClinicalTrials.gov