Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis

Phase 4

Recruiting

• Conditions: inflammatory bowel disease; Ulcerative colitis; 10017969

• Registration Number: NL-OMON52704
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1. Adult UC patients (>=18 years) , 2. Admission with acute severe UC (defined
patients with bloody diarrhoea >= 6/day and any signs of systemic toxicity
(pulse > 90/min, temperature > 37.8°C, haemoglobin < 105 g/l,
erythrocyte sedimentation rate [ESR] > 30 mm/h, or C-reactive protein [CRP]
> 30 mg/l) , 3. Failure to intravenous steroid treatment as defined by the
Oxford criteria (more than 8 stools/d or 3-8 stools/d and CRP>=45 on day 3 after
starting iv steroid treatment), 4. Patients going through baseline endoscopy
and biopsy sampling (including CMV) before starting on IFX treatment, 5. In the
opinion of the investigator, the subject is capable of understanding and
complying with protocol requirements. , 6. The subject signs and dates a
written, informed consent form and any required privacy authorization prior to
the initiation of any study procedures.

Exclusion Criteria

1. Patients at imminent need of surgery as judged by the treating clinician, 2.
Previous use of IFX, 3. Enteric pathogens (such as Salmonella, Shigella,
Yershinia, Campylobacter and C. difficile) detected by stool analysis within 2
weeks prior to enrollment or at screening, 4. Active participation in another
interventional trial, 5. Patients with Crohn*s disease or IBD-U, 6. Patients
with abdominal abscess, 7. Patients with colonic stricture, 8. Patients with a
history of colon cancer or colonic dysplasia, unless sporadic adenoma, which
has been removed, 9. Active or latent tuberculosis (screening according to
national guidelines), 10. Cardiac failure in NYHA stage III-IV , 11. History of
demyelinating disease, 12. Recent live vaccination , 13. Patients with ongoing
acute/chronic infection (including but not limited to HIV, hepatitis B and C)
with the exception of chronic herpes labialis or cervical HPV, 14. History of
cancer in the last 5 years with the exception of non-melanoma skin cancer, 15.
A history of alcohol or illicit drug use that in the opinion of the principal
investigator (PI) would interfere with study procedures, 16. Patients with
psychiatric problems that in the opinion of the PI would interfere with study
procedures, 17. Patients unable to attend all study visits, 18. Patients with a
history of non-compliance with clinical study protocols, 19. Contraindication
for endoscopy , 20. Patients who received any investigational drug in the past
30 days or 5 half-lives, whichever is longer, 21. Patients who received
cyclosporine in the previous 14 days, 22. Pregnancy and lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment success at week 8, defined as a combination of<br /><br>- sustained clinical response (defined as a Lichtiger score of < 10 points with<br /><br>a decrease of at least 3 points compared to baseline maintained until week 8)<br /><br>AND<br /><br>- endoscopic response (defined as a decrease of at least 2 points in the UCEIS<br /><br>at week 8 endoscopy compared to baseline)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Proportion of patients in remission at week 8 and 26 as measured by the Mayo<br /><br>score (Mayo score <= 2 with no individual subscore >1)<br /><br>- Proportion of patients with response at week 8 and 26 as measured by the Mayo<br /><br>score (decrease in Mayo score >= 3 points and >=30% from baseline and a decrease<br /><br>in the rectal bleeding subscore >=1 or an absolute rectal bleeding subscore of 0<br /><br>or 1)<br /><br>- Proportion of patients in clinical remission at week 8 and 26 as measured by<br /><br>the Simple Clinical Colitis Activity Index (SCCAI score <= 2)</p><br>