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)

An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Crohn's Disease
How many people: 101 participants
Where: No sites listed yet
Study dates: Jan 2013to May 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with moderate-to-severe Crohn's Disease

Who may be able to join

1. Crohn's Disease participants were defined as:
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.
Fecal Calprotectin greater than or equal to 150 microgram/g.
Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Who cannot join

Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
Participants who had undergone colectomy other than ileocecal resection.
Pregnancy or breast feeding.
Contraindication to any anti-tumor necrosis factors (TNF) agent.
Any drug dependency.

About this study

Official title: An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience

Conditions: Crohn's Disease
Keywords: Fecal Calprotectin, Crohn's Disease, Adalimumab
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01759264
Study group	Role	What they receive
Moderate-to-severe Crohn's disease		Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Week 4

Secondary outcomes (4)

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.
Measured: At Week 8 and 12
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.
Measured: 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.
Measured: 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.
Measured: At Week 4, 8, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2014

First posted3 Jan 2013 (estimated)
Study startJan 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01759264
Sponsor's protocol ID: P13-974
Acronym: FAIR
Status last verified: Jun 2015
First submitted: 28 Dec 2012
Last updated: 8 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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Ibd CAncer and seRious Infections in France (I-CARE 2)
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RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience
ClinicalTrials.gov ID: NCT01759264
Acronym / sponsor ID: FAIR / P13-974
Conditions: Crohn's Disease
Keywords: Fecal Calprotectin, Crohn's Disease, Adalimumab
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 3 Jan 2013 (estimated)
Results: Posted 8 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Moderate-to-severe Crohn's disease	–	–Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with moderate-to-severe Crohn's Disease

Key inclusion criteria (4 listed)

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.
Fecal Calprotectin greater than or equal to 150 microgram/g.
Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Key exclusion criteria (5 listed)

Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
Participants who had undergone colectomy other than ileocecal resection.
Pregnancy or breast feeding.
Contraindication to any anti-tumor necrosis factors (TNF) agent.
Any drug dependency.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
Time frame: 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.

4 secondary outcomes

Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
Time frame: At Week 8 and 12
Mean Percent Change of Fecal Calprotectin From Baseline
Time frame: Week 4, 8, and 12
Percentage of Participants With Remission of Crohn's Disease
Time frame: At Week 4, 8, and 12
Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment
Time frame: At Week 4, 8, and 12

Results and safety

Results posted to the registry on 8 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate-to-severe Crohn's Disease	101	91

Primary outcome: Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram

Time frame: At Week 4. Number. Unit: Percentage of participants

Measure	Moderate-to-severe Crohn's Disease (ITT Population) n = 93	Moderate-to-severe Crohn's Disease (PP Population) n = 83
Value	16.30	13.25

Population analysed: 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).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events leading to discontinuation of adalimumab treatment were collected from signing of informed consent until 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate-to-severe Crohn's Disease	6 of 99 (6.1%)	2 of 99 (2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Crohn's Disease

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SoRa Lee, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram (time frame: At Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01759264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.