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: June 12, 2015
Last verified: June 2015
  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:

Primary Outcome Measures:
  • Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: SoRa Lee, 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
Results First Received: May 26, 2015
Last Updated: June 12, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AbbVie:
Fecal Calprotectin
Crohn's Disease
Adalimumab

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

ClinicalTrials.gov processed this record on August 31, 2015