Stopping anti-TNF treatment in Crohn's and Colitis patients in remission
Key facts
- Where
- Kristianstad, Linkoping, Malmo és Solna, SvédországSee the 4 sites
- Phase
- 4. fázis
Where in Svédország
- Region Skane Kristianstad Central HospitalKristianstad, SvédországTaking people
- Region OestergoetlandLinkoping, SvédországTaking people
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországTaking people
- Karolinska University HospitalSolna, SvédországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- EU 2024-513299-17-00
- Record updated
- 2024. szeptember 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: 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.