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

Ulcerative Colitis Clinical Trial

— BEAT-IBD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03059849
• Other study ID #: 2831
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Ulcerative Colitis

Intervention

Drug:
• Adalimumab
Dose of adalimumab will be increased by 40mg every 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year