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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02768532
Date of registration: 02/05/2016
Prospective Registration: Yes
Primary sponsor: Centre Hospitalier Universitaire de Saint Etienne
Public title: Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease VEDO-PREDIRESP
Scientific title: VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease
Date of first enrolment: July 1, 2016
Target sample size: 93
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02768532
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Xavier Roblin, MD
Address: 
Telephone:
Email: xavier.roblin@chu-st-etienne.fr
Affiliation: 
Name:     Xavier Roblin, MD
Address: 
Telephone:
Email:
Affiliation:  CHU SAINT ETIENNE
Key inclusion & exclusion criteria

Inclusion Criteria :

- Aged over 18 years

- Men or non-pregnant women

- Patients with a diagnosis of Crohn's disease who requires to start Vedolizumab

- Crohn's disease defined as a Crohn's disease Activity Index (CDAI) > 150 points and/or
fecal calprotectin levels > 250 µg/g of stool

- Crohn's Disease patients with previous failure with TNF (Tumor Necrosis Factor)
antagonist agents and unacceptable side-effects from steroids, and/or
immunosuppressive agents (i.e., azathioprine, 6-mercaptopurine, or methotrexate). In
France, Vedolizumab has to be prescribed only in patients in failure or intolerant to
anti-TNF.

- Patient taking corticosteroids orally, concomitant immunosuppressive agents,
mesalamine, and antibiotics are allowed at stable dose for at least three months
before inclusion. Steroid tapering has to be set up at Week 10 after starting
Vedolizumab, according to the European Crohn and Colitis Organisation (ECCO)
recommendations with a progressive decrease of steroids of 5 mg/day every week until
complete withdrawn.

- Informed written consent given.

Exclusion Criteria:

- Existing pregnancy, lactation, or intended pregnancy within the next 15 months

- Minors or History of disease, including mental/emotional disorder that might interfere
with their participation in the study

- Serious secondary illnesses of an acute or chronic nature, which in the opinion of the
investigator renders the patient unsuitable for inclusion into the study

- Inability to comply with the protocol requirements

- Inability to fill in the diary cards during the last 7 days before each visit

- Presence of an ileo-/colonic stoma

- Patients with known colonic stricture and exclusive or predominant anal or perineal
Crohn's disease lesions

- Known previous or concurrent malignancy (other than that considered surgically cured,
with no evidence for recurrence for 5 years)

- Short bowel syndrome

- Previous treatments with natalizumab, efalizumab or rituximab.

- Previous treatment with adalimumab within 30 days prior enrollment or infliximab and
certolizumab pegol within 60 days before enrollment. This deadline can be shortened by
judgment of investigator.

- Prior extensive colonic resection, obstructive (symptomatic) intestinal stricture,
abdominal abscess, active or latent tuberculosis,

- Documented Clostridium difficile superinfection;

- Indeterminate colitis

- Concomitant leukocyte apheresis.

- Any contraindication to vedolizumab therapy

- Patients who denied the protocol, not ability to accept or sign consent of the
protocol

- Subject involved in another interventional clinical trial



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Vedolizumab concentration at week 6 [Time Frame: Week 6]
Secondary Outcome(s)
Concentration of Vedolizumab at week 14 [Time Frame: Week 14]
Concentration of Vedolizumab at week 2 [Time Frame: Week 2]
Concentration of Vedolizumab at week 54 [Time Frame: Week 54]
Intra and inter-individual heterogeneity of Vedolizumab levels [Time Frame: Week 54]
Presence of specific antibodies (anti-integrins) at week 14 [Time Frame: Week 14]
Presence of specific antibodies (anti-integrins) at week 2 [Time Frame: Week 2]
Proportion of loss of clinical response [Time Frame: Week 54]
Specific antibodies (anti-integrins) level at week 54 [Time Frame: Week 54]
Vedolizumab and calprotectin levels at week 14 [Time Frame: Week 14]
Vedolizumab and calprotectin levels at week 2 [Time Frame: Week 2]
Vedolizumab concentration at week 14 [Time Frame: Week 14]
Vedolizumab serum levels [Time Frame: Week 54]
Secondary ID(s)
1608051
2016-001587-11
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda
Theradiag
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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