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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe Crohn's disease | Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease |
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| 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 |
| 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 |
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Inclusion Criteria:
1. Crohn's Disease participants were defined as:
Exclusion Criteria:
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Participants with moderate-to-severe Crohn's Disease
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| Name | Affiliation | Role |
|---|---|---|
| SoRa Lee, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate-to-severe Crohn's Disease | Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Stool
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 |
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Safety Analysis Set (SAS): Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate-to-severe Crohn's Disease | Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Fecal Calprotectin | Mean | Standard Deviation | microgram/gram |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation). | Posted | Number | Percentage of participants | At Week 8 and 12 |
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| 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. | Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation). | Posted | Number | Percentage of participants | At Week 4 |
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| 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. | Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation). | Posted | Mean | Standard Deviation | Percentage | Week 4, 8, and 12 |
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| 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. | Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation). | Posted | Number | Percentage of participants | At Week 4, 8, and 12 |
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| 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. | Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation). | Posted | Number | Percentage of participants | At Week 4, 8, and 12 |
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Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate-to-severe Crohn's Disease | Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease | 6 | 99 | 2 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA V17.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA V17.0 | Non-systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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