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)

Crohn's Disease Clinical Trial

— FAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759264
• Other study ID #: P13-974
• Status: Completed
• Phase: N/A
• First received: December 28, 2012
• Last updated: June 12, 2015
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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