An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC
- Conditions
- lcerative colitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-005443-40-NL
- Lead Sponsor
- Academic Medical Center/ Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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 ulcerative colitis with histopathological confirmation available in the record of the patient.
6. Moderate to severe active UC (total Mayo score > 6) with objective evidence of inflammation that can be visualized on endoscopy. All endscopies will be video-taped for later review, rereading and quality assurance. Patients must have an endoscopic Mayo score of 2 or 3.
7. Anti-TNF discontinued for at least 6 weeks
8. Written informed consent must be obtained and documented
GROUP 1 (EARLY UC)
1.Diagnosis of UC < 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.
2.Demonstrated failure to respond to aminosalicylates or intolerance to aminoslicylates
and: failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
or: need for > 1 course of steroids per year
or: steroid dependency at any dose
GROUP 2 (LATE UC)
1.Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
2.Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates and: failure to respond to at least 3 months of thiopurines or intolerance to TP 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. Loss of response to anti-TNF is defined as recurrence of symptoms during maintenance dosing following prior clinical benefit.
May continue stable dose of conventional therapies for IBD incl aminosalicylates and thiopurines and corticosteroids. Steroids will be tapered by protocol by week 14. Anti-TNF must be discontinued for > 6 weeks.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Prior treatment with vedolizumab.
2. Contraindication for endoscopy.
3. History of colonic dysplasia/cancer
4. Extensive colonic resection, i.e. subtotal or total colectomy with <15 cm colon remaining
5. Received other biologics within the last 6 weeks of screening
6. Use of 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 PML subjective symptom checklist before enrollment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 UC in an 'early' and a 'late' disease population after 54 weeks of treatment.;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. ;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 a Mayo Clinic score =2 and no subscore >1 .;Timepoint(s) of evaluation of this end point: Week 26 and week 52-54
- Secondary Outcome Measures
Name Time Method