Trial Outcomes & Findings for 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) (NCT NCT01759264)

NCT ID: NCT01759264

Last Updated: 2015-07-08

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 101 participants
• Primary outcome timeframe: At Week 4
• Results posted on: 2015-07-08

Participant Flow

Participant milestones

Measure	Moderate-to-severe Crohn's Disease Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Overall Study STARTED	101
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Moderate-to-severe Crohn's Disease Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Overall Study Serious Adverse Events (SAEs)	1
Overall Study Adverse Event	1
Overall Study Other	2
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Discontinued Humira Due to Business Trip	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Measure	Moderate-to-severe Crohn's Disease n=99 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Age, Continuous	30.72 Years STANDARD_DEVIATION 8.90 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants
Fecal Calprotectin Per ITT Set (N=92)	1799.59 microgram/gram STANDARD_DEVIATION 2275.28 • n=5 Participants
Fecal Calprotectin Per PP Set (N=83)	1871.02 microgram/gram STANDARD_DEVIATION 2345.65 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n=93 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease	Moderate-to-severe Crohn's Disease (PP Population) n=83 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram	16.30 Percentage of participants	13.25 Percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n=93 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease	Moderate-to-severe Crohn's Disease (PP Population) n=83 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram At Week 8	21.84 Percentage of participants	20.25 Percentage of participants
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram At Week 12	18.82 Percentage of participants	17.07 Percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n=93 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease	Moderate-to-severe Crohn's Disease (PP Population) n=83 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Mean Percent Change of Fecal Calprotectin From Baseline Percent Change at Week 4 (N=92, 83)	-34.60 Percentage Standard Deviation 59.85	-39.28 Percentage Standard Deviation 58.59
Mean Percent Change of Fecal Calprotectin From Baseline Percent Change at Week 8 (N=86, 79)	-43.14 Percentage Standard Deviation 51.59	-45.08 Percentage Standard Deviation 50.32
Mean Percent Change of Fecal Calprotectin From Baseline Percent Change at Week 12 (N=85, 82)	-10.49 Percentage Standard Deviation 147.38	-22.43 Percentage Standard Deviation 88.76

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n=93 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease	Moderate-to-severe Crohn's Disease (PP Population) n=83 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Percentage of Participants With Remission of Crohn's Disease CDAI scores less than 150 at Week 8	72.94 Percentage of participants	76.92 Percentage of participants
Percentage of Participants With Remission of Crohn's Disease CDAI scores less than 150 at Week 4	66.30 Percentage of participants	69.51 Percentage of participants
Percentage of Participants With Remission of Crohn's Disease CDAI scores less than 150 at Week 12	83.53 Percentage of participants	83.95 Percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n=93 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease	Moderate-to-severe Crohn's Disease (PP Population) n=83 Participants Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR70 at Week 4	86.96 Percentage of participants	87.80 Percentage of participants
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR70 at Week 8	89.41 Percentage of participants	92.31 Percentage of participants
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR70 at Week 12	94.12 Percentage of participants	95.06 Percentage of participants
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR100 at Week 4	75.00 Percentage of participants	76.83 Percentage of participants
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR100 at Week 8	85.88 Percentage of participants	88.46 Percentage of participants
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment CR100 at Week 12	90.59 Percentage of participants	91.36 Percentage of participants

Adverse Events

Moderate-to-severe Crohn's Disease

Serious events: 6 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Moderate-to-severe Crohn's Disease n=99 participants at risk Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Gastrointestinal disorders Abdominal pain	3.0% 3/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Gastrointestinal disorders Aphthous stomatitis	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Gastrointestinal disorders Diarrhoea	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Gastrointestinal disorders Large intestinal stenosis	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Gastrointestinal disorders Melaena	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Injury, poisoning and procedural complications Hand fracture	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Skin and subcutaneous tissue disorders Rash	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks

Other adverse events

Measure	Moderate-to-severe Crohn's Disease n=99 participants at risk Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
Gastrointestinal disorders Abdominal pain	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Gastrointestinal disorders Large intestinal stenosis	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks
Infections and infestations Urinary tract infection	1.0% 1/99 • Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

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