N/A
Completed N=101
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)
Source: ClinicalTrials.gov NCT01759264 ↗Enrolled (actual)
101
Serious AEs
6.1%
Results posted
Jul 2015
Primary outcomePrimary: Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram — 16.30; 13.25 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram |
16.30; 13.25 | — |
| SECONDARY Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram |
16.30; 13.25 | — |
| SECONDARY Mean Percent Change of Fecal Calprotectin From Baseline |
-34.60; -39.28; -43.14; -45.08; -10.49; -22.43 | — |
| SECONDARY Percentage of Participants With Remission of Crohn's Disease |
66.30; 69.51; 72.94; 76.92; 83.53; 83.95 | — |
| SECONDARY Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment |
86.96; 87.80; 89.41; 92.31; 94.12; 95.06 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01759264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.