Boosting Biologics in UC

Korábbi kezelés

• Previous use of anti-TNF medication
• Concomitant use of non-steroid anti-inflammatory drugs (NSAIDS) or corticosteroids
• Concomitant use of antithrombotic pharmaceutical substances
• Regular (weekly) use of any probiotic substance within 3 months prior to inclusion
• Use of antibiotics within 3 months prior to inclusion

Más betegség

• History of bowel resection, other inflammatory bowel disease (IBD)-related surgery, or other major intestinal surgery
• Plasma hepatitis C (HCV) positive
• HIV positive
• Comorbidity of coeliac disease or malnutrition
• Heart failure (NYHA class II-IV)

Laborértékek

• Signs of severe ulcerative colitis as defined by the "Montreal classification of severity of ulcerative colitis" = 3: Passage of at least six bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5°C, haemoglobin of less than 10.5 g/100 ml, and erythrocyte sedimentation rate (ESR) of at least 30 mm/h.
• Serum hepatitis B surface antigen (HBsAg) positive
• Deranged liver function (serum albumin < 25 g/L or Child-Pugh ≥10)
• Renal failure (estimated glomerular filtration rate (eGFR) < 30

Egyéb

• Clinical status poor to such extent that treating physician finds refraining from escalation of treatment contraindicated
• Pregnancy
• Any reason why, in the opinion of the investigator, the patient should not participate

• Subjects may be included as cases in the study if they meet all of the following criteria:
• Diagnosed With ulcerative colitis based on Lennard-Jones criteria
• Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
• Failure to Reach remission upon routine evaluation colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≥ using the Mayo score for ulcerative colitis
• Age 18-75
• Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
  • Subjects may be included as Control subjects in the sub-study if they meet all of the following criteria:
• Diagnosed With ulcerative colitis based on Lennard-Jones Criteria
• Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
• Remission upon routine colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≤ using the Mayo score for ulcerative colitis
• Age 18-75
• Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
  • OR if they meet all the following criteria:
• No history of inflammatory bowel disease
• Age 18-75
• Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.