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Trial record 10 of 18 for:    celiac | Open Studies | United States

Vedolizumab Induction May Prevent Celiac Enteritis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by AGA Clinical Research Associates, LLC
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Barry Kaufman, MD, AGA Clinical Research Associates, LLC
ClinicalTrials.gov Identifier:
NCT02929316
First received: October 5, 2016
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein found in wheat, barley, rye, malt) induces an immunological response in genetically susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the population worldwide. Long term sequelae are numerous and include risk of lymphoma, malabsorption leading to weight loss, anemia, multiple vitamin deficiencies, osteoporosis/osteopenia, secondary autoimmunity, etc. (1)

Condition Intervention Phase
Celiac Disease
Drug: Vedolizumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission

Resource links provided by NLM:


Further study details as provided by AGA Clinical Research Associates, LLC:

Primary Outcome Measures:
  • Normal histopathology following induction dosing with vedolizumab [ Time Frame: 12 weeks ]
    Remission is defined in this study of negative celiac antibodies and normal duodenal biopsies

  • Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange [ Time Frame: 12 weeks ]
    Remission is defined in this study as negative celiac antibodies and normal duodenal biopsies


Estimated Enrollment: 10
Study Start Date: October 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab
Vedolizumab (Entyvio) 300mg IV at week 0, 2 and 6
Drug: Vedolizumab
IV infusion week 0, 2 and 6
Other Name: Entyvio

Detailed Description:
Adult subjects with CD will be recruited through our clinic. All patients enrolled will have established CD diagnosed > 6 months. All patients will have history of abnormal MARSH score on initial duodenal biopsy at diagnosis and MARSH 0 on repeat biopsy following a gluten free diet (GFD). All patients will also have positive celiac serologies (anti-TTG, anti-gliadin, etc.) at diagnosis, as well as, positive HLA DQ2/DQ8 genetic profile. At enrollment, all patients will have negative celiac serologies, indicative of serologic remission on a gluten free diet. Female subjects of childbearing potential (does not include those with history of tubal ligation/surgical sterilization, hysterectomy and/or oophorectomy) who are sexually active with a non-sterilized male partners agree to routinely use adequate contraception from signing informed consent, during study process and for an additional 18 weeks after the last dose of vedolizumab. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing informed consent throughout the duration of the study and for 18 weeks after the last dose.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must meet the following criteria for study entry:
  • Adult patients with Celiac Disease (CD)
  • Without any additional co-morbidities
  • Normal renal and hepatic function
  • Diagnosis of CD established at least 6 months prior to trial with diagnostic serology, genetic profile, endoscopic appearance and histopathology report In histologic and serologic remission (defined as MARSH 0 and negative anti-tissue transglutaminase, etc.) following a gluten free diet
  • Naïve to treatment with vedolizumab
  • Able and willing to provide written informed consent
  • Eligibility criteria for laboratory profiles - healthy patient normal laboratory reference values

    • WBC 4.5-12.0 k/UL
    • Platelet count- 140-415 k/UL
    • Hemoglobin- 11.0-17.4 %g/dL
    • Renal Function-
    • Creatinine- 0.5-1.3 mg/dL
    • BUN- 5-20 mg/dL
    • Hepatic Function
    • Albumin - 3.3-5.0 g/dL
    • INR- 0.9-1.1
    • AST- 0-37 U/L
    • ALT- 0-40 U/L
    • Total Bilirubin- 0.1-1.3 mg/dL
    • Alk Phos- 35-150 U/L

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Abnormal MARSH score on enrollment histopathology
  • Elevated celiac serologies (anti-tissue transglutaminase, etc.)
  • Current use of biologics or immunomodulators Adalimumab, infliximab, Ustekinumab, Golimumab, Tocilizumab, Certolizumab, Etanercept, Rituximab, Anakinra, Abatacept, Tofacitinib, Methotrexate, Azathioprine, 6-MP.
  • Current use of immunosuppressive therapy including intermittent systemic corticosteroids within two months of vedolizumab induction
  • History of intestinal lymphoma (MALToma, etc.)
  • History of cancer including hematologic malignancy, solid tumors, carcinoma in situ, etc.
  • Pregnant or lactating
  • Fertile females will require at least one form of birth control
  • Lack of peripheral venous access
  • Inability to comply with study protocol, in the opinion of the investigator
  • Neurological conditions which may interfere with monitoring for PML
  • History of demyelinating disease or history of major neurological disease
  • History of alcohol, drug or chemical abuse < 6 months prior to screening
  • History of active tuberculosis (TB) or a positive screening test for latent mycobacterium tuberculosis infection
  • Positive PPD= > 10 mm or > 5mm in patients on 15 mg or more of prednisone
  • History of BCG vaccination should be screened using Quantiferon TB Gold test
  • An Indeterminate Quantiferon test will require a chest X-ray to rule out active TB and consultation with an infectious disease specialist to confirm the risk of latent
  • TB is low and that patients can be safely enrolled in the trial
  • History of recurrent opportunistic infections and/or of severe or disseminated viral infections
  • Active autoimmune disease
  • Active inflammatory bowel disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02929316

Contacts
Contact: Theresa Stevens, MSN, APN,C 609-407-1220 ext 1108 theresa@atlanticgastro.com

Locations
United States, New Jersey
AGA Clinical Research Associates, LLC Not yet recruiting
Egg Harbor Township, New Jersey, United States, 08234
Theresa Stevens Not yet recruiting
Egg Harbor Twp, New Jersey, United States, 08234
Contact: Theresa Stevens, MSN, APN,C    609-407-1220 ext 1108    Theresa@atlanticgastro.com   
Sponsors and Collaborators
AGA Clinical Research Associates, LLC
Takeda
  More Information

Publications:

Responsible Party: Barry Kaufman, MD, Director of Clinical Research, AGA Clinical Research Associates, LLC
ClinicalTrials.gov Identifier: NCT02929316     History of Changes
Other Study ID Numbers: IISR-2016-101481
Study First Received: October 5, 2016
Last Updated: October 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Celiac Disease
Enteritis
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Gastroenteritis
Vedolizumab
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 28, 2017