Crohn's Disease Clinical Trial
— FAIROfficial 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
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 |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
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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