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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02324699
Date of registration: 19/12/2014
Prospective Registration: Yes
Primary sponsor: Icahn School of Medicine at Mount Sinai
Public title: Corticosteroids With Vedolizumab in Crohn's Disease
Scientific title: Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
Date of first enrolment: April 2016
Target sample size: 1
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02324699
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Bruce E Sands, MD, MS
Address: 
Telephone:
Email:
Affiliation:  Icahn School of Medicine at Mount Sinai Hospital
Key inclusion & exclusion 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-TNFa 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-TNFa 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Placebo
Drug: Prednisone
Drug: Vedolizumab
Primary Outcome(s)
Crohn's Disease Activity Index (CDAI) [Time Frame: baseline, week 6, week 10]
Secondary Outcome(s)
Change in C-Reactive Protein (CRP) [Time Frame: baseline and week 10]
Change in Calprotectin [Time Frame: baseline, week 6 and week 10]
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: baseline and week 10]
Secondary ID(s)
GCO 14-2209
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda
Ethics review
Results
Results available: Yes
Date Posted: 26/04/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02324699
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