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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759264
First Posted: January 3, 2013
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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.

Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram [ Time Frame: 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:
  • Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Stool

Enrollment: 101
Study Start Date: January 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate-to-severe Crohn's disease
Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with moderate-to-severe Crohn's Disease
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759264


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: SoRa Lee, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01759264     History of Changes
Other Study ID Numbers: P13-974
First Submitted: December 28, 2012
First Posted: January 3, 2013
Results First Submitted: May 26, 2015
Results First Posted: July 8, 2015
Last Update Posted: July 8, 2015
Last Verified: June 2015

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Fecal Calprotectin
Crohn's Disease
Adalimumab

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents