Stopping anti-TNF treatment in Crohn’s and Colitis patients in remissio

Phase 1

• Conditions: Crohn´s diseaseUlcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-000235-40-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-10
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 332
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

For patients with ulcerative colitis:
• Corticosteroid (rectal or systemic) or rectal 5-ASA treatment during the last 6 months.
• Colonic resection.
• Pregnancy.

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.
• Corticosteroid (rectal or systemic) or rectal 5-ASA treatment during the last 6 months.
• Colonic surgery with removal of more than half of the transverse colon.
• Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): The proportion of patients that relapses, as defined by symptomatic scoring in combination with endoscopy, at 12 and 24 months after discontinuation of anti-TNF treatment with identification of factors at study-start that correlate positively or negatively with the event of relapse.;Timepoint(s) of evaluation of this end point: time-points 12 and 24 months