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NCT Number: NCT01759264

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)

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Crohn's Disease participants were defined as:
  • 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.
  • Fecal Calprotectin greater than or equal to 150 microgram/g.
  • Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Exclusion criteria

  • Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
  • Participants who had undergone colectomy other than ileocecal resection.
  • Pregnancy or breast feeding.
  • Contraindication to any anti-tumor necrosis factors (TNF) agent.
  • Any drug dependency.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Acronym: FAIR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2013
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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