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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT03937609
Date of registration: 30/04/2019
Prospective Registration: Yes
Primary sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Public title: TITRATE (inducTIon for acuTe ulceRATivE Colitis) TITRATE
Scientific title: 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
Date of first enrolment: September 4, 2019
Target sample size: 120
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Name:     Geert DHaens, PI
Telephone: 0031205663534
Name:     Geert DHaens
Affiliation:  Amsterdamumc location AMC
Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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

2. Failure to intravenous steroid treatment as defined by the Oxford criteria (more than
8 stools/d or 3-8 stools/d and CRP=45) and a Lichtiger score = 10 on day 3 after
starting iv steroid treatment

3. Patients going through baseline endoscopy and biopsy sampling (including CMV) before
starting on IFX treatment

4. In the opinion of the investigator, the subject is capable of understanding and
complying with protocol requirements.

5. The subject signs and dates a written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.

6. Male or non-pregnant, non-lactating females. Females of child bearing potential must
have a negative serum pregnancy test prior to randomization, and must use a hormonal
(oral, implantable or injectable) or barrier method of birth control throughout week
26. Females unable to bear children must have documentation of such in the source
records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum
of one year since the last menstrual period]).

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

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Drug: Infliximab
Primary Outcome(s)
Increased treatment success [Time Frame: week 6]
Secondary Outcome(s)
Clinical Remission [Time Frame: Week 6 and week 26]
Corticosteroid-free remission [Time Frame: week 26]
Endoscopic Remission [Time Frame: week 6 and week 26]
Endoscopic Reponse [Time Frame: week 6 and week 26]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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