Crohn Disease, Ulcerative Colitis
Conditions
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.
Interventions
DRUGAdalimumab
Dose of adalimumab will be increased by 40mg every 2 weeks.
Sponsors
McMaster University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed