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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:  NCT02646683
Date of registration: 27/08/2015
Prospective Registration: Yes
Primary sponsor: Geert D'Haens
Public title: A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study LOVE-CD
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)
Date of first enrolment: July 2015
Target sample size: 260
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02646683
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Belgium Hungary Netherlands
Contacts
Name:     Severine Vermeire, Prof
Address: 
Telephone:
Email:
Affiliation: 
Name:     Esmé Clasquin, Drs.
Address: 
Telephone: 0031205666545
Email: e.clasquin@amc.uva.nl
Affiliation: 
Name:     Geert D'Haens, Prof
Address: 
Telephone:
Email:
Affiliation:  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 > 2 courses of steroids since diagnosis or: steroid
dependency at any dose since diagnosis and additionally, but not mandatory, lack of
efficacy of thiopurines or intolerance to thiopurines (any duration). Patients who are
using thiopurines at screening must have used them for > 3 months (last 4 weeks at
stable dose).

GROUP 2 (LATE CD)

10. Demonstrated failure to respond to 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.

Exclusion Criteria:

1. Previous exposure to any anti-integrin antibodies including- vedolizumab ; a4ß7
anti-bodies ; ß7 antibodies ; anti- MADCAM-1

2. Contraindication for endoscopy.

3. History of colonic dysplasia/cancer

4. Presence of stoma

5. Received other biologics within the last 4 weeks of baseline

6. Use of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/suppositories within 2
weeks of enrollment

7. Chronic hepatitis B or C infection

8. Evidence of or treatment for C. difficile infection or other intestinal pathogen at
screening within 4 weeks prior to enrollment

9. Active or latent tuberculosis

10. Conditions which in the opinion of the investigator may interfere with the subject's
ability to comply with the study procedures.

11. Received any investigational drug in the past 30 days or 5 half-lives, whichever is
longer.

12. Positive progressive multifocal leukoencephalopathy ( PML) subjective symptom
checklist before enrollment.

13. Subjects with known allergy or hyposensitivity to vedolizumab or its components



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: vedolizumab
Primary Outcome(s)
The proportion of patients with clinical and endoscopic remission at Week 26 [Time Frame: week 26]
Secondary Outcome(s)
Proportion of patients that need to be hospitalized [Time Frame: 52 weeks]
Proportion of patients with 25% and 75% reduction of SES-CD at Weeks 26 and 52 [Time Frame: 26 and 52 weeks]
Proportion of patients with 25%, 50% and 75% reduction in the Geboes histology score at Weeks 26 and 52 [Time Frame: Week 26 and week 52]
Proportion of patients with clinical remission [Time Frame: 52 weeks]
Proportion of patients with clinical response [Time Frame: 52 weeks]
Proportion of patients with corticosteroid- free clinical remission [Time Frame: 52 weeks]
Proportion of patients with draining fistulas [Time Frame: 52 weeks]
Proportion of patients with endoscopic response at Weeks 26 and 52 [Time Frame: 26 and 52 weeks]
Proportion of patients with no granulocytes in the biopsies at Weeks 26 and 52. [Time Frame: Week 26 and week 52]
Proportion of patients with normalized serum C-reactive protein (CRP) at all time points [Time Frame: 52 weeks]
Proportion of patients with sustained clinical remission [Time Frame: After week 10]
Proportion of patients with sustained clinical response (response at all time points after week 10) [Time Frame: After week 10]
Quality of life measured by Euroqol (EQ-5D) [Time Frame: Screening, week 10, week 26 and week 52]
Quality of life measured by Inflammatory Bowel Disease Questionnaire ( IBDQ) [Time Frame: Screening, week 10, week 26 and week 52]
Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion [Time Frame: 52 weeks]
Work productivity Index [Time Frame: Screening, week 10, week 26 and week 52]
Secondary ID(s)
2014-100757
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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