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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: EUCTR
Last refreshed on: 8 January 2018
Main ID:  EUCTR2014-005376-29-HU
Date of registration: 30/08/2017
Prospective Registration: Yes
Primary sponsor: Academic Medical Center, Gastroenterology
Public title: An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's disease
Scientific title: An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD
Date of first enrolment: 13/10/2017
Target sample size: 260
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005376-29
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Belgium Hungary Netherlands
Contacts
Name: IBD Trial Office   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 31205661125
Email: e.clasquin@amc.uva.nl
Affiliation:  Academic Medical Center
Name: IBD Trial Office   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 31205661125
Email: e.clasquin@amc.uva.nl
Affiliation:  Academic Medical Center
Key inclusion & exclusion criteria
Inclusion criteria:
1. In the opinion of the investigator, the subject is capable of understanding and complying with
protocol requirements.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Age 18 to 80.
4. 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 the study. 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]).
5. Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
6. Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
7. Anti-TNF discontinued for at least 4 weeks prior to baseline.

GROUP 1 (EARLY CD):
8. Diagnosis of CD < 24 months prior to enrollment.
9. Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
or: need for 1 course of steroids since diagnosis
or: steroid dependency at any dose since diagnosis,
and additionally, but not mandatory, lack of efficacy or intolerance to thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine)(any duration). Patients using thiopurines must have been using the agent for > 3 months (last 4 weeks at stable dose).

GROUP 2 (LATE CD):
10. Diagnosis of CD > 24 months prior to enrollment.
11. Subject has been treated with corticosteroids and demonstrated failure to respond to corticosteroids and at least 3 months of thiopurines or intolerance to thiopurines
and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.



Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Previous exposure to any anti-integrin antibodies including vedolizumab, a4ß7 antibodies, ß7 antibodies, anti-MADCAM-1.
2. Contraindication for endoscopy.
3. History of colonic dysplasia or colonic cancer.
4. Presence of stoma.
5. Subjects with a pouch.
6. Received other biologics within the last 4 weeks of baseline.
7. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment.
8. Chronic hepatitis B or C infection.
9. Subjects with ALT or AST 3x the upper limit of normal measured at screening.
10. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment.
11. Active or latent tuberculosis.
12. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
13. Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
14. Positive PML subjective symptom checklist before enrollment.
15. Subjects with known allergy or hyposensitivity to vedolizumab or its components.
16. Cancer (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence). Subjects with a history of cancer and a documented 2-year disease free period before screening, may enter the study.
17. Early CD group: previous exposure to any anti-TNF.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Entyvio
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)
Main Objective: To assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active Crohn's disease in an 'early' and a 'late' disease population after 54 weeks of treatment.
Primary end point(s): The proportion of patients with clinical and endoscopic remission at Week 26 and 52-54, defined as CDAI of 150 or lower and SES-CD <4
Secondary Objective: Measures of clinical disease activity (including clinical response and remission) over the 1 year study period will be described. The mucosal healing capacity of vedolizumab treatment will be observed by assessing the endoscopic and histopathologic response to treatment over the 1 year study period.
Timepoint(s) of evaluation of this end point: week 26 and week 52
Secondary Outcome(s)
Secondary end point(s): - Proportion of patients with absence of ulcers at Weeks 26 and 52-54
- Proportion of patients with endoscopic response (SES-CD reduction by = 50 %) at Weeks 26 and 52
- Proportion of patients with 25% and 75% reduction of SES-CD at Weeks 26 and 52
- Proportion of patients with clinical response (CDAI decrease of = 70 points from baseline) at all time points
- Proportion of patients with clinical remission (CDAI =150) at all other time points
- Proportion of patients with corticosteroid-free clinical remission (CDAI =150) at all other time points
- Proportion of patients with normalized serum CRP at all time points
- Proportion of patients with no granulocytes in the biopsies at Weeks 26 and 52
- Proportion of patients with 25%, 50% and 75% reduction in the Geboes histology score at Weeks 26 and 52
- Proportion of patients with sustained clinical response (response at all time points after and on week 10)
- Proportion of patients with sustained clinical remission (remission at all time points after week 10)
- Proportion of patients with draining fistulas
- Proportion of patients that need to be hospitalized
- Quality of life measured by IBDQ and Euroquol
- Work productivity Index
- Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion
Timepoint(s) of evaluation of this end point: week 26 and week 52
Secondary ID(s)
2014-005376-29-NL
2014-100757
Source(s) of Monetary Support
Takeda
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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