A Phase 4 interventional study of vedolizumab in Crohn Disease, sponsored by Geert D'Haens. Completed at 23 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Geert D'Haens · Phase 4, Interventional, and Treatment
This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 86 patients with 'early CD' defined as disease duration \< 24 months and no other treatments than corticosteroids and/or thiopurines and 174 patients with 'late CD' defined as active disease despite treatment with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF will also be allowed in the latter group. Participants will be treated with 12 months of open label vedolizumab (study medication followed by commercial medication once reimbursement is available) and undergo monitoring of endoscopic, histological and clinical disease parameters. No randomization or blinding will be performed but the study management will ensure that recruitment in either study group is comparable for number and profile of patients (on/off steroids).
Crohn's disease (CD) is a chronic inflammatory disease of the small bowel and colon. Symptoms commonly include bloody diarrhea, abdominal pain, weight loss, and fever. There is no known cause or cure for CD. The aim of current CD treatments is to induce and maintain remission, to reduce the need of corticosteroids and avoid resections and fistulas.
Treatment options include systemic and/or topical corticosteroids, purine analogues (6-mercaptopurine and azathioprine), anti-TNF antibodies and surgery. In 2013, results from the GEMINI II, phase 3, randomized controlled trial demonstrated the efficacy of vedolizumab (VDZ) in inducing and maintaining remission in adult patients with active CD.
VDZ (MLN0002, or MLN02), inhibits the interaction between α4β7 integrin on memory T and B cells and mucosal addressin cell adhesion molecule-1 expressed on the vascular endothelium of the gut and has been shown to be effective in both inducing and maintaining clinical remission in ulcerative colitis. The ideal positioning of vedolizumab in the therapeutic armamentarium for CD remains unknown. With other (anti-TNF) biologics, outcomes have usually been better if the treatment was started earlier in the disease course and if the patients had not been exposed to prior antibody treatments. Therefore, it appears appropriate and desirable to test the potency of vedolizumab in an earlier phase of CD.
Indeed, also with vedolizumab patients previously exposed to biologics appear to have lower success rates with vedolizumab, so a position earlier in the disease course would most likely lead to better outcomes.
This is an investigator-initiated open label study of VDZ therapy in 2 distinct populations of CD patients with active disease: 1. patients who have been diagnosed \< 2 years ago and who only been exposed to aminosalicylates and corticosteroids and 2. patients who have been exposed to immunomodulators and/or anti-TNF agents in addition to steroids and aminosalicylates.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 260 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Geert D'Haens is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Anti-TNF discontinued for at least 4 weeks prior to baseline.
GROUP 1 (EARLY CD):
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)
Exclusion Criteria:
VEDOLIZUMAB 300 mg at week 0,2,6, (10), 14, 22, 30,(34), 38, (42), 46, (50) week 10 = only required for subjects not responding week 34, 42 and 50- only required for subjects who have no endoscopic improvement at week 26
Drug: vedolizumab
VEDOLIZUMAB 300 mg at week 0,2,6, (10), 14, 22, 30,(34), 38, (42), 46, (50) week 10 = only required for subjects not responding week 34, 42 and 50- only required for subjects who have no endoscopic improvement at week 26
Drug: vedolizumab
Also known as: Entyvio
The proportion of patients with clinical and endoscopic remission at Week 26
Crohns disease activity index (CDAI) of 150 or lower and Simple endoscopic score for Crohn's disease (SES-CD) \< 4.
Time frame: week 26
Proportion of patients with endoscopic response at Weeks 26 and 52
SES-CD reduction by ≥ 50 %
Time frame: 26 and 52 weeks
Proportion of patients with 25% and 75% reduction of SES-CD at Weeks 26 and 52
SES-CD reduction
Time frame: 26 and 52 weeks
Proportion of patients with clinical response
CDAI decrease of ≥ 70 points from baseline
Time frame: 52 weeks
Proportion of patients with clinical remission
(CDAI \<=150) at all time other points
Time frame: 52 weeks
Proportion of patients with corticosteroid- free clinical remission
(CDAI \<=150) at all other time points
Time frame: 52 weeks
Proportion of patients with normalized serum C-reactive protein (CRP) at all time points
CRP
Time frame: 52 weeks
Proportion of patients with no granulocytes in the biopsies at Weeks 26 and 52.
No granulocytes
Time frame: Week 26 and week 52
Proportion of patients with 25%, 50% and 75% reduction in the Geboes histology score at Weeks 26 and 52
Geboes score
Time frame: Week 26 and week 52
Proportion of patients with sustained clinical response (response at all time points after week 10)
Geboes score reduction
Time frame: After week 10
Proportion of patients with sustained clinical remission
(remission at all time points after week 10)
Time frame: After week 10
Proportion of patients with draining fistulas
Fistula
Time frame: 52 weeks
Proportion of patients that need to be hospitalized
Time frame: 52 weeks
Quality of life measured by Inflammatory Bowel Disease Questionnaire ( IBDQ)
Questionnaire
Time frame: Screening, week 10, week 26 and week 52
Work productivity Index
Questionnaire
Time frame: Screening, week 10, week 26 and week 52
Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion
through concentration
Time frame: 52 weeks
Quality of life measured by Euroqol (EQ-5D)
Questionnaire
Time frame: Screening, week 10, week 26 and week 52
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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