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)

NCT01759264 | Completed Results

• 1 other identifier: P13-974
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

Fecal Calprotectin; Crohn's Disease; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram

  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.

  At Week 4

Secondary Outcomes (4)

• Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram

  At Week 8 and 12

• Mean Percent Change of Fecal Calprotectin From Baseline

  Week 4, 8, and 12

• Percentage of Participants With Remission of Crohn's Disease

  At Week 4, 8, and 12

• Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment

  At Week 4, 8, and 12

Study Arms (1)

Moderate-to-severe Crohn's disease

Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with moderate-to-severe Crohn's Disease

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• SoRa Lee, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 8, 2015
• Results First Posted: July 8, 2015

Record last verified: 2015-06