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)

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience

Conditions
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Crohn's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate-to-severe Crohn's disease<br>Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Calprotectin, Crohn's Disease, Adalimumab