Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET (In-TARGET)

This is an interventional treatment trial for ULCERATIVE COLITIS focused on measuring UC, IBD Read More

INCLUSION CRITERIA

• Age sup 18 years and inf 75 years
• Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and or proctitis are allowed).
• Adults with moderately-to-severely active UC who had an inadequate response to or failed to tolerate steroids AND thiopurines (azathioprine or 6-mercaptopurine) or adults with moderately-to-severely active UC who had no response to an adequate steroid course and starting golimumab.
• Active disease at golimumab treatment initiation defined as a partial MAYO score sup/equal 6 with an endoscopic sub score sup/equal 2.
• Patients concurrently treated with oral corticosteroids will receive a stable dose (prednisone 20 ≤mg/day for at least 2 weeks) before baseline.
• Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication. If the patient is not on oral 5-ASA during the screening period, he/she should start mesalamine at 2g per day or asacol at 1.6 g per day, in the absence of contra-indication.
• Patients are allowed stable dose of thiopurines (azathioprine or 6-mercaptopurine stable dose for at least 4 weeks).
• Naïve to anti-TNF therapy, and other biologics, including anti-integrin antibodies and for all biologics known to be effective for UC (approved or investigational).
• Naïve to JAK inhibitors (approved or investigational)
• A contraceptive method during the whole study for childbearing potential female patients.

EXCLUSION CRITERIA

• Age under 18 and over 75.
• People unable to give their consent (because of their physical or mental state).
• Absence of written consent.
• Pregnancy or breastfeeding.
• Patients with severe acute colitis or patients at imminent risk for colectomy.
• History of colectomy.
• History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
• Screening stool study positive for enteric pathogens or Clostridium difficile toxin.
• Oral corticosteroids at a dose > 20 mg prednisone or its equivalent per day.
• Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics, including anti-integrin antibodies (approved or investigational), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first study agent injection.

• Contraindication to anti-TNF therapy according to drug labelling:

  • Active infection.
  • Non-treated latent tuberculosis.
  • Heart failure (NYHA: Grade III and IV).
  • Malignancy during the previous 5 years.
  • Demyelinating neurological disease.
  • Should be vaccinated with attenuated live vaccines