Crohn's Disease
Conditions
Keywords
Fecal Calprotectin, Crohn's Disease, Adalimumab
Brief 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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Crohn's Disease participants were defined as: 1. 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. 2. Fecal Calprotectin greater than or equal to 150 microgram/g. 3. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.
Exclusion criteria
1. Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract. 2. Participants who had undergone colectomy other than ileocecal resection. 3. Pregnancy or breast feeding. 4. Contraindication to any anti-tumor necrosis factors (TNF) agent. 5. Any drug dependency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 8 and 12 | 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. |
| Mean Percent Change of Fecal Calprotectin From Baseline | Week 4, 8, and 12 | 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. |
| Percentage of Participants With Remission of Crohn's Disease | At Week 4, 8, and 12 | 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. |
| Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | At Week 4, 8, and 12 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate-to-severe Crohn's Disease Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Discontinued Humira Due to Business Trip | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 2 |
| Overall Study | Serious Adverse Events (SAEs) | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Moderate-to-severe Crohn's Disease |
|---|---|
| Age, Continuous | 30.72 Years STANDARD_DEVIATION 8.9 |
| Fecal Calprotectin Per ITT Set (N=92) | 1799.59 microgram/gram STANDARD_DEVIATION 2275.28 |
| Fecal Calprotectin Per PP Set (N=83) | 1871.02 microgram/gram STANDARD_DEVIATION 2345.65 |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 99 |
| serious Total, serious adverse events | 6 / 99 |
Outcome results
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.
Time frame: At Week 4
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | 16.30 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | 13.25 Percentage of participants |
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.
Time frame: Week 4, 8, and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Crohn's Disease (ITT Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 4 (N=92, 83) | -34.60 Percentage | Standard Deviation 59.85 |
| Moderate-to-severe Crohn's Disease (ITT Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 8 (N=86, 79) | -43.14 Percentage | Standard Deviation 51.59 |
| Moderate-to-severe Crohn's Disease (ITT Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 12 (N=85, 82) | -10.49 Percentage | Standard Deviation 147.38 |
| Moderate-to-severe Crohn's Disease (PP Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 4 (N=92, 83) | -39.28 Percentage | Standard Deviation 58.59 |
| Moderate-to-severe Crohn's Disease (PP Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 8 (N=86, 79) | -45.08 Percentage | Standard Deviation 50.32 |
| Moderate-to-severe Crohn's Disease (PP Population) | Mean Percent Change of Fecal Calprotectin From Baseline | Percent Change at Week 12 (N=85, 82) | -22.43 Percentage | Standard Deviation 88.76 |
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.
Time frame: At Week 4, 8, and 12
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 4 | 86.96 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 8 | 89.41 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 12 | 94.12 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 4 | 75.00 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 8 | 85.88 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 12 | 90.59 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 8 | 88.46 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 4 | 87.80 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 4 | 76.83 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 8 | 92.31 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR100 at Week 12 | 91.36 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment | CR70 at Week 12 | 95.06 Percentage of participants |
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.
Time frame: At Week 8 and 12
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 8 | 21.84 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 12 | 18.82 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 8 | 20.25 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram | At Week 12 | 17.07 Percentage of participants |
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.
Time frame: At Week 4, 8, and 12
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 4 | 66.30 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 12 | 83.53 Percentage of participants |
| Moderate-to-severe Crohn's Disease (ITT Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 8 | 72.94 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 4 | 69.51 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 8 | 76.92 Percentage of participants |
| Moderate-to-severe Crohn's Disease (PP Population) | Percentage of Participants With Remission of Crohn's Disease | CDAI scores less than 150 at Week 12 | 83.95 Percentage of participants |