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 (prior sponsor, Abbott)101 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Crohn's Disease participants were defined as: 1. 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. 2. Fecal Calprotectin greater than or equal to 150 microgram/g. 3. 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.

Outcomes

Primary Outcomes

Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram

Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.

Time frame: At Week 4

Secondary Outcomes

Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram

Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.

Time frame: At Week 8 and 12

Mean Percent Change of Fecal Calprotectin From Baseline

Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.

Time frame: Week 4, 8, and 12

Percentage of Participants With Remission of Crohn's Disease

Crohn's Disease Activity Index (CDAI) was a composite index consisting of a weighted scoring of eight disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, a higher score indicates increased disease severity. Clinical remission was defined as CDAI score less than 150.

Time frame: At Week 4, 8, and 12

Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment

CR70 and CR100 was a decrease from baseline (Week 0) in CDAI score of 70 and 100 or more points, respectively, a lower score indicating improvement in disease activity.

Time frame: At Week 4, 8, and 12

Data from ClinicalTrials.gov

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