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

Phase 4

Withdrawn

• Conditions: Crohn Disease; Ulcerative Colitis
• Interventions: Drug: Adalimumab

• Registration Number: NCT03059849
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Study Start: 2018-02-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-09-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temporary increase in adalimumab	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Number of patients with clinical relapse	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.