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)

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT01759264
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-28
• Study First Submitted QC: 2012-12-28
• Study Start: 2013-01
• Study First Posted: 2013-01-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-26
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-12
• Last Update Submitted: 2015-06-12
• Results First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram	At Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram	At Week 8 and 12	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.
Mean Percent Change of Fecal Calprotectin From Baseline	Week 4, 8, and 12	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.
Percentage of Participants With Remission of Crohn's Disease	At Week 4, 8, and 12	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.
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment	At Week 4, 8, and 12	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.