ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroids With Vedolizumab in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02324699
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Bruce E. Sands, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Prednisone Drug: Placebo Drug: Vedolizumab Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
Study Start Date : April 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prednisone co-inductive therapy
Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5
Drug: Prednisone
Other Name: corticosteroids

Drug: Vedolizumab
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Other Name: Entyvio

Placebo Comparator: Placebo
Identical placebo taper
Drug: Placebo
Drug: Vedolizumab
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Other Name: Entyvio




Primary Outcome Measures :
  1. Crohn's Disease Activity Index (CDAI) [ Time Frame: at week 6 ]
    Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores


Secondary Outcome Measures :
  1. CDAI [ Time Frame: at week 10 ]
  2. Change in CDAI [ Time Frame: baseline and week 6 ]
    clinical response (change in CDAI > 100) as compared to baseline from week 6

  3. Change in CDAI [ Time Frame: baseline and week 10 ]
    clinical response (change in CDAI > 100) as compared to baseline from week 10

  4. Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: baseline and week 6 ]
    The SES-CD tool is used to quantify and compare inflammatory load.

  5. Change in SES-CD [ Time Frame: baseline and week 10 ]
  6. Change in C-Reactive Protein (CRP) [ Time Frame: baseline and week 10 ]
    Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body.

  7. Change in calprotectin [ Time Frame: baseline and week 6 ]
    Comparison of absolute change in calprotectin from baseline to week 6. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines.

  8. Change in calprotectin [ Time Frame: baseline and week 10 ]
    Comparison of absolute change in calprotectin from baseline to week 10



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324699


Contacts
Contact: Neeraj Narula 212-241-2230 neeraj.narula@medportal.ca

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Bruce E Sands, MD, MS         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Takeda
Investigators
Principal Investigator: Bruce E Sands, MD, MS Icahn School of Medicine at Mount Sinai Hospital

Responsible Party: Bruce E. Sands, Professor of Medicine Division of Gastroenterology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02324699     History of Changes
Other Study ID Numbers: GCO 14-2209
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Bruce E. Sands, Icahn School of Medicine at Mount Sinai:
Vedolizumab
Corticosteroids
Prednisone
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Prednisone
Vedolizumab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gastrointestinal Agents