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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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01759264
First received: December 28, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

This study aims to monitor fecal calprotectin (FC) level in moderate-to-severe Korean Crohn's Disease (CD) patients on Adalimumab induction treatment.


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 While on Adalimumab Induction Therapy: a KoRean Experience (FAIR)

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of patients with fecal calprotectin < 150 microgram/g [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with fecal calprotectin < 150 microgram/g [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percentage of patients with fecal calprotectin < 150 microgram/g [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Mean percent change of fecal calprotectin [ Time Frame: From Day 0 to Week 4 ] [ Designated as safety issue: No ]
  • Mean percent change of fecal calprotectin [ Time Frame: From Day 0 to Week 8 ] [ Designated as safety issue: No ]
  • Mean percent change of fecal calprotectin [ Time Frame: From Day 0 to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients in clinical remission and Percentage of clinical response patients [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of patients in clinical remission and Percentage of clinical response patients [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percentage of patients in clinical remission and Percentage of clinical response patients [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Stool


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate-to-severe Crohn's disease
Patients with moderate-to-severe Crohn's disease on Adalimumab induction therapy

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General hospital

Criteria

Inclusion Criteria:

1. Crohn's disease patients:

  1. Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) > 220, who will start Adalimumab treatment in normal clinical practice setting
  2. Fecal Calprotectin (FC) over 150 microgram/g.
  3. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

2. Signed authorization form to use personal and/or health data prior to the entry into the study.

Exclusion Criteria:

  1. Disease patterns restricted to proximal (small bowel, gastroduodenal) GI areas.
  2. Patients who have undergone colectomy other than ileocecal resection.
  3. Pregnancy or breast feeding.
  4. Contraindication to any anti-TNF agent
  5. Any drug dependency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759264

Locations
Korea, Republic of
Site Reference ID/Investigator# 91901
Daegu, Korea, Republic of, 705-717
Site Reference ID/Investigator# 91893
Seoul, Korea, Republic of, 138-736
Site Reference ID/Investigator# 91896
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Deborah Chee, MD AbbVie
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01759264     History of Changes
Other Study ID Numbers: P13-974
Study First Received: December 28, 2012
Last Updated: April 16, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AbbVie:
Fecal Calprotectin

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

ClinicalTrials.gov processed this record on May 16, 2013