Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD (BEAT-IBD)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion criteria
- Adults ages 18 and older with Crohn's disease and ulcerative colitis
- Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
- 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
- Pregnant women or plans for pregnancy within 3 months of study inclusion
- Abdominal abscess
- Inability or unwillingness to provide informed consent
- Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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