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) (FAIR)

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

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 Overview

• Status: Completed
• Conditions: Crohn's Disease

• Study Type: Observational
• Enrollment (Actual): 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with moderate-to-severe Crohn's Disease

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Moderate-to-severe Crohn's disease; Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At Week 4, 8, and 12

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: SoRa Lee, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Fecal Calprotectin; Crohn's Disease; Adalimumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: P13-974