Crohn´s disease Ulcerative colitis
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Endoscopic scores at 12 and 24 months among those who relapsed compared to those who remained in remission. • Fecal calprotectin levels at 12 and 24 months among those who relapsed compared to those who remained in remission. • Fecal calprotectin levels at study start among ulcerative colitis patients who relapsed compared to those who remained in remission. • The rate of relapse among ulcerative colitis patients with the following fecal calprotectin level ranges (7.0 ug/ml for infliximab, and =10.0 ug/ml for adalimumab. • The optimal trough concentration cut-off with regards to sensitivity and specificity for relapse, for infliximab and adalimumab, respectively. • Area under the infliximab or adalimumab concentration curve during the last therapy cycle among those who relapsed compared to those who remained in remission. • Presence of anti-drug antibodies among those who relapsed compared to those who remained in remission. • The rate of relapse among those with anti-drug antibodies versus those without. • Time to relapse among those who relapse, comparing ADA versus IFX treated and UC versus CD. • The level of gut microbiota dysbiosis among those who relapsed compared to those who remained in remission. • The rate of relapse among those with a dysbiosis score of 1, 2-3, and 4-5, respectively. • Correlation analyses of genes showing high versus low expression in mucosal biopsies and blood samples, with the event of relapse. • Correlation analyses of gene-variants with the event of relapse. • Additional factors that will be correlated with relapse rates: Endoscopic scores (Baron score 0 versus 1 for UC and SES-CD 0-1 versus 3-4 for Crohn's disease); corticosteroid use between 12 and 6 months before baseline; previous anti-TNF treatment; dose intensification of anti-TNF treatment; mono- versus concomitant immunomodulator-treatment; previously maximal inflammatory extent (Montreal classification); disease duration (10 years); ex | — |
Countries
Sweden
Contacts
Public ContactJan Marsal
Region Skåne
Outcome results
None listed