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Withdrawn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
About this trial
This is an interventional treatment trial for Crohn Disease
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
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
NCT ID
NCT03059849
First Posted
February 13, 2017
Last Updated
January 13, 2020
Sponsor
McMaster University
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Withdrawn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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