An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2014-005376-29-NL
• Date of registration: 08/01/2015
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center, Gastroenterology
• Public title: An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.
• Scientific title: An open-label observational 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: 29/06/2015
• 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

Countries of recruitment

Netherlands

Contacts

• Name: IBD trial office
• Affiliation: Academic Medical Center

• Name: IBD trial office
• Affiliation: Academic Medical Center

Key inclusion & exclusion criteria

Inclusion criteria:
- Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
- Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
- Anti-TNF discontinued for at least 6 weeks
-Age 18 to 80

- GROUP 1 (EARLY CD):
Diagnosis of CD < 24 months prior to enrollment
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

GROUP 2 (LATE CD)
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.

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:
- Prior treatment with vedolizumab.
- Contraindication for endoscopy.
- History of colonic dysplasia/cancer
- Presence of stoma
- Received other biologics within the last 6 weeks of screening
- Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
- Chronic hepatitis B or C infection
- Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
- Active or latent tuberculosis
- Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
- Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- Positive PML subjective symptom checklist before enrollment.
- Subjects with known allergy or hyposensitivity to vedolizumab or its components



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Crohn's disease

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): The primary endpoint is 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.

Main Objective: The primary objective of this prospective open label study is 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.

Timepoint(s) of evaluation of this end point: Week 26 and week 52

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 26 and week 52

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 time other 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
- WHO Disability Index
- Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion

Secondary ID(s)

2014-100757

Source(s) of Monetary Support

Takeda