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Recruitment below expectation
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The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life [QoL]), workability, and disease activity.
This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a adalimumab containing regimen has to be decided in advance and has to be current practice. The prescription of adalimumab is clearly separated from the decision to include the participant in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate to Severe Ulcerative Colitis | Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire | The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe ulcerative colitis
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Dorr, MD | AbbVie Austria | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate to Severe Ulcerative Colitis | Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All enrolled participants with demographic and baseline data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate to Severe Ulcerative Colitis | Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided. | Enrolled participants with Month 12 data at the time of study termination | Posted | Number | percentage of participants | Month 12 |
|
Serious adverse events were collected from the time informed consent was obtained until 70 days after the last dose of study drug (up to 14.5 months).
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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 Ulcerative Colitis | Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| No therapeutic response | General disorders | MedDRA (19.0) | Systematic Assessment |
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The study was terminated due to low enrollment; therefore, safety and efficacy data should be interpreted with caution because of the small number of participants and incomplete data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 1-800-633-9110 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Baseline (Day 0) to Month 12 |
| Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ) | The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL. | Baseline (Day 0) to Month 12 |
| Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score | A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]). | Baseline (Day 0) to Month 12 |
| Correlation Between fC and Disease Activity Determined by Partial Mayo Score | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA). | Baseline (Day 0) to Month 12 |
| Correlation Between fC and Patient's QoL Determined by the sIBDQ | fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). | Baseline (Day 0) to Month 12 |
| Correlation Between fC and Workability Determined by WPAI:UC Questionnaire | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline (Day 0) to Month 12 |
| years |
|
| Gender | Count of Participants | Participants |
|
| Fecal calprotectin (fC) levels at baseline | fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A total of 8 participants had fC baseline data available. | Mean | Standard Deviation | μg/g |
|
|
|
| Secondary | Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire | The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
|
| Secondary | Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ) | The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL. | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
|
| Secondary | Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score | A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]). | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
|
| Secondary | Correlation Between fC and Disease Activity Determined by Partial Mayo Score | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA). | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
|
| Secondary | Correlation Between fC and Patient's QoL Determined by the sIBDQ | fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
|
| Secondary | Correlation Between fC and Workability Determined by WPAI:UC Questionnaire | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | The study was terminated due to low enrollment and data were not collected. | Posted | Baseline (Day 0) to Month 12 |
|
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| 2 |
| 10 |
| 0 |
| 10 |
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.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |