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

McMaster University

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Crohn Disease Ulcerative Colitis

Interventions

AdalimumabDRUG

Dose of adalimumab will be increased by 40mg every 2 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: One year

Data from ClinicalTrials.gov

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