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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03059849
Recruitment Status : Unknown
Verified February 2017 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Ulcerative Colitis Drug: Adalimumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: Temporary increase in adalimumab Drug: Adalimumab
Dose of adalimumab will be increased by 40mg every 2 weeks.

No Intervention: Continued monitoring as per standard of care



Primary Outcome Measures :
  1. Number of patients with clinical relapse [ Time Frame: One year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03059849


Contacts
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Contact: Cindy James 905 525 9140 ext 22641 jamesc5@mcmaster.ca

Sponsors and Collaborators
McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03059849     History of Changes
Other Study ID Numbers: 2831
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents