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Taking people in SwedenPhase 4

Stopping anti-TNF medicine in Crohn's disease or ulcerative colitis in remission

Studies who can stop anti-TNF medicine in Crohn's or colitis.

Key facts

Who runs it
Region Skane
Where
Kristianstad, Linkoping, Malmo, and Solna, SwedenSee the 4 sites
Registry title
Stopping anti-TNF treatment in Crohn's and Colitis patients in remission
Status
Recruiting
Phase
Phase 4
People taking part
350 people, planned
Started
5 May 2017
Planned end
1 May 2026
Type of study
Interventional
Record updated
9 September 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ulcerative colitis or Crohn's disease who are in remission on anti-TNF treatment (infliximab or adalimumab). It studies who can safely stop this treatment.

Age
18-80 years
Sex
Men and women
Disease stage
In remission. Ulcerative colitis: SCCAI score of 3 or less and endoscopic Baron score of 0-1. Crohn's disease: sHBI score of 4 or less, SES-CD of 4 or less, and no ulcer of 5 mm or more other than a possible anastomotic ulcer.
Earlier treatment
Treated with IFX or ADA for more than 12 months, with the last 3 doses at the same dose and interval. Biosimilar infliximab: at least 3 doses at the same dose and interval. No corticosteroid (rectal or systemic) or rectal 5-ASA in the last 6 months.
Biomarker or test result
Crohn's disease: F-calprotectin below 200 mg/kg (PhiCal) or below 350 mg/kg (Buhlmann).

Main reasons for not taking part

  • Pregnancy
  • Corticosteroid or rectal 5-ASA treatment in the last 6 months
  • Ulcerative colitis: colonic resection
  • Crohn's disease: inflammation of the small bowel more than 50 cm (20 in) from the ileocecal valve
  • Crohn's disease: colonic surgery removing more than half of the transverse colon

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • For patients with ulcerative colitis: • Diagnosis: Ulcerative colitis • Age 18-80 years. • Male or female. • IFX or ADA treatment since >12 months; last 3 doses at the same dose and interval. If the patient is on a biosimilar-infliximab the patient must have received at least 3 doses, and at the same dose and interval. • SCCAI score of ≤3. • Endoscopic Baron score of 0-1. The most inflamed part in the rectum/ sigmoid colon is evaluated. A minimum of 40 cm of the colon should be examined
  • For patients with Crohn's disease: • Diagnosis: Crohn's disease • Age 18-80 years. • Male or female. • IFX or ADA treatment since >12 months; last 3 doses at the same dose and interval. If the patient is on a biosimilar-infliximab the patient must have received at least 3 doses, and at the same dose and interval. • Simplified HBI (sHBI; abdominal palpation excluded) score of ≤4. • Simplified Endoscopic Score for CD (SES-CD) of ≤4 and no ulcer ≥5 mm other than a potential anastomotic ulcer (ie apthous ulcers allowed). • F-calprotectin <200 mg/kg (PhiCal) or <350 mg/kg (Buhlmann)

Who cannot take part

  • Corticosteroid (rectal or systemic) or rectal 5-ASA treatment during the last 6 months
  • For patients with ulcerative colitis: Colonic resection
  • For patients with Crohn's disease: Documented engagement/inflammation of the small bowel proximally of a level of 50 cm from the ileocecal valve. Any examination modality is accepted, and a current/new small intestinal examination is not required. A limited number of small (<5 mm) lesions on capsule endoscopy allowed. Colonic surgery with removal of more than half of the transverse colon
  • Pregnancy

Where in Sweden

  • Region Skane Kristianstad Central HospitalKristianstad, SwedenTaking people
  • Region OestergoetlandLinkoping, SwedenTaking people
  • Region Skane Skanes UniversitetssjukhusMalmo, SwedenTaking people
  • Karolinska University HospitalSolna, SwedenTaking people

About the trial

What the trial wants to find out

The aim is to identify clinical and biological markers that offer guidance as to which patients successfully may discontinue maintenance anti-TNF treatment, and which patients on the contrary need to continue treatment over an extended period of time in order to remain in remission.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Stopping anti-TNF treatment in Crohn's and Colitis patients in remission
Plain-language title
Stopping anti-TNF medicine in Crohn's disease or ulcerative colitis in remissionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
9 September 2024