A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): vedolizumab
Intervention type(s): Drug
Other intervention name(s): Entyvio
Intervention MeSH terms: Vedolizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment