Trial Outcomes & Findings for Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo (NCT NCT02092389)
NCT ID: NCT02092389
Last Updated: 2017-02-23
Results Overview
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.
TERMINATED
10 participants
Month 12
2017-02-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo
Baseline characteristics by cohort
| Measure |
Moderate to Severe Ulcerative Colitis
n=10 Participants
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.
|
|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 16.88 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
|
Fecal calprotectin (fC) levels at baseline
|
440 μg/g
STANDARD_DEVIATION 393.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Enrolled participants with Month 12 data at the time of study termination
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.
Outcome measures
| Measure |
Moderate to Severe Ulcerative Colitis
n=2 Participants
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.
|
|---|---|
|
Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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 \[PGA\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 12Population: The study was terminated due to low enrollment and data were not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Moderate to Severe Ulcerative Colitis
Serious adverse events
| Measure |
Moderate to Severe Ulcerative Colitis
n=10 participants at risk
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.
|
|---|---|
|
General disorders
No therapeutic response
|
20.0%
2/10 • 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).
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Information
AbbVie
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER