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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01759264
First received: December 28, 2012
Last updated: May 27, 2014
Last verified: May 2014
  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:


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


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759264

Locations
Korea, Republic of
Site Reference ID/Investigator# 109795
Ansan, Korea, Republic of, 425-707
Site Reference ID/Investigator# 91900
Busan, Korea, Republic of, 602-739
Site Reference ID/Investigator# 91901
Daegu, Korea, Republic of, 705-717
Site Reference ID/Investigator# 109815
Guri, Korea, Republic of, 471-701
Site Reference ID/Investigator# 109775
Incheon, Korea, Republic of, 405-760
Site Reference ID/Investigator# 91893
Seoul, Korea, Republic of, 138-736
Site Reference ID/Investigator# 91898
Seoul, Korea, Republic of, 158-710
Site Reference ID/Investigator# 91896
Seoul, Korea, Republic of, 130-872
Site Reference ID/Investigator# 91894
Seoul, Korea, Republic of, 135-710
Site Reference ID/Investigator# 91899
Seoul, Korea, Republic of, 136-705
Site Reference ID/Investigator# 91895
Seoul, Korea, Republic of
Site Reference ID/Investigator# 91897
Seoul, Korea, Republic of, 110-744
Site Reference ID/Investigator# 91873
Suwon, Korea, Republic of, 442-723
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Deborah Chee, MD AbbVie
  More Information

Additional Information:
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: May 27, 2014
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 July 20, 2014