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

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study ID
NCT02994836
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-TNF: Infliximab (Infusion) — BIOLOGICAL
    Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
  • Anti-TNF discontinuation: Physiological saline solution — DRUG
    Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
  • Anti-TNF:Adalimumab (Subcutaneus) — BIOLOGICAL
    Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
  • Anti-TNF discontinuation: Physiological saline solution — DRUG
    Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Study Details

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

Key Dates

Start date
Apr 21, 2017
Status verified
Feb 2023
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
139 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Anti-TNF
    Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)
  • Placebo Comparator: Anti-TNF discontinuation (Placebo)
    Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use)

Primary Outcome Measure

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

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