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Trial record 3 of 3 for:    22619366 [PUBMED-IDS]

Vedolizumab Induction May Prevent Celiac Enteritis

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ClinicalTrials.gov Identifier: NCT02929316
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Barry Kaufman, MD, AGA Clinical Research Associates, LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Celiac Disease Drug: Vedolizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Vedolizumab
Vedolizumab (Entyvio) 300mg IV at week 0, 2 and 6
Drug: Vedolizumab
IV infusion week 0, 2 and 6
Other Name: Entyvio




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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): 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 Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Theresa Stevens Recruiting
Egg Harbor Township, 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

Publications of Results:

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
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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