An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01759264

P13-974

Details and patient eligibility

About

The objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's Disease who were treated with adalimumab.

Enrollment: 101 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Crohn's Disease participants were defined as:

2. Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) greater than 220, who started Adalimumab treatment in a normal clinical practice setting.

3. Fecal Calprotectin greater than or equal to 150 microgram/g.

4. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Exclusion criteria

1. Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
2. Participants who had undergone colectomy other than ileocecal resection.
3. Pregnancy or breast feeding.
4. Contraindication to any anti-tumor necrosis factors (TNF) agent.
5. Any drug dependency.

Trial design

101 participants in 1 patient group

Moderate-to-severe Crohn's disease

Description:

Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease