Clinical trial NCT02324699: Corticosteroids With Vedolizumab in Crohn's Disease
Official title: Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Vedolizumab
Corticosteroids
Prednisone
Crohn's disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2014-12-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

Detailed description: This study will examine prednisone co-induction with vedolizumab in patients with Crohn's disease. To address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. Finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in Crohn's disease through immune phenotyping studies.

Eligibility criteria: Inclusion Criteria:

* Age at entry 18 to 70
* CDAI score \> 220
* Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for \> 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (\>2 weeks from last dose) prior to initiation of vedolizumab.
* Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
* Able to provide written informed consent.
* Patient is planned for or eligible to initiate vedolizumab

Exclusion Criteria:

* Concurrent use of anti-TNFα antibodies.
* No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
* No stoma at the time of enrollment
* No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
* Pregnant women or plans for pregnancy within 3 months of study inclusion
* Presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome
* Intestinal stricture requiring surgery
* Abdominal abscess
* Inability or unwillingness to provide informed consent
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Primary outcomes:
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: baseline, week 6, week 10
Secondary outcomes:
measure: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: baseline and week 10
measure: Change in C-Reactive Protein (CRP)
timeFrame: baseline and week 10
measure: Change in Calprotectin
timeFrame: baseline, week 6 and week 10
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai Hospital
name: Bruce E Sands, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: