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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01759264
Other study ID # P13-974
Secondary ID
Status Completed
Phase N/A
First received December 28, 2012
Last updated June 12, 2015
Start date January 2013
Est. completion date May 2014

Study information

Verified date June 2015
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 8 and 12 No
Secondary Mean Percent Change of Fecal Calprotectin From Baseline 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. Week 4, 8, and 12 No
Secondary Percentage of Participants With Remission of Crohn's Disease 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. At Week 4, 8, and 12 No
Secondary Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment 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. At Week 4, 8, and 12 No
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