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Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD (BEAT-IBD)

Primary Purpose

Crohn Disease, Ulcerative Colitis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults ages 18 and older with Crohn's disease and ulcerative colitis
  2. Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
  3. Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).

Exclusion Criteria:

  1. Pregnant women or plans for pregnancy within 3 months of study inclusion
  2. Abdominal abscess
  3. Inability or unwillingness to provide informed consent
  4. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Temporary increase in adalimumab

    Continued monitoring as per standard of care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients with clinical relapse
    Clinical relapse will be based on increased clinical symptoms or endoscopic changes requiring use of corticosteroids, addition of an immunomodulator, change to another biologic therapy, or surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2017
    Last Updated
    January 13, 2020
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03059849
    Brief Title
    Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
    Acronym
    BEAT-IBD
    Official Title
    Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of funding
    Study Start Date
    February 1, 2018 (Anticipated)
    Primary Completion Date
    February 1, 2019 (Anticipated)
    Study Completion Date
    September 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.
    Detailed Description
    Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease, Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Temporary increase in adalimumab
    Arm Type
    Active Comparator
    Arm Title
    Continued monitoring as per standard of care
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Adalimumab
    Intervention Description
    Dose of adalimumab will be increased by 40mg every 2 weeks.
    Primary Outcome Measure Information:
    Title
    Number of patients with clinical relapse
    Description
    Clinical relapse will be based on increased clinical symptoms or endoscopic changes requiring use of corticosteroids, addition of an immunomodulator, change to another biologic therapy, or surgery.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults ages 18 and older with Crohn's disease and ulcerative colitis Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score < 2 or Harvey-Bradshaw Index < 4) Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly). Exclusion Criteria: Pregnant women or plans for pregnancy within 3 months of study inclusion 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

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