Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

An observational study of Crohn Disease, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy with infliximab and determine whether changes in the levels of the selected biomarkers can be used to predict endoscopically assessed gut mucosal status changes. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Crohn Disease
What is being tested?: Infliximab
Type of treatment: Injection or infusion
How many people: 15 participants
Where: No sites listed yet
Study dates: 28 Nov 2012to 28 Sep 2015
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Study population: Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.

Who may be able to join

Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
History of colonic involvement verified by prior endoscopy or radiography
Indicated for treatment with infliximab according to current best medical practice
Body Mass Index (BMI) between 15 kg/m^2 and 35 kg/m^2
Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception
Negative pregnancy test
No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration

Who cannot join

Pregnancy, intention to become pregnant, or breastfeeding
Evidence of a colon unaffected by CD
Indication for surgery
Perianal disease likely to interfere with study participation
Presence of a stoma or history of colectomy
Symptomatic diarrhea unrelated to CD

Show all 20Show fewer

Strictures or evidence of bowel obstruction
Presence of abscess unless completed definitive treatment can be documented one week prior to screening
Presence of fistulas
Contraindication to infliximab
Intolerance to sedatives or other medications required for endoscopy
Any prior use of anti-inflammatory biologic therapy
Moderate or severe congestive heart failure
History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening
Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)
History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix
History of systemic granulomatous infection
History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry
Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow

About this study

Official title: An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)

Conditions: Crohn Disease
Being tested: Infliximab
Keywords: biological markers, endoscopy, gastrointestinal
Medical subject headings: Crohn Disease

What participants receive

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

InfliximabDrug
Also called Remicade, SCH 215596, MK-2155
Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.

Study groups in NCT01349920
Study group	Role	What they receive
Infliximab 5 mg/kg		Infliximab treatment and endoscopy. Receives: Drug: Infliximab

What is being measured

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

Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Measured: Baseline and Week 6
Change From Baseline in CDEIS Blinded Score at Week 22
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Measured: Baseline and Week 22
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Measured: Baseline and Week 6
Change From Baseline in Serum hsCRP at Week 22
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Measured: Baseline and Week 22
Change From Baseline in Stool Calprotectin at Week 6
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Measured: Baseline and Week 6
Change From Baseline in Stool Calprotectin at Week 22
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Measured: Baseline and Week 22
Change From Baseline in Serum Lipocalin-2 at Week 6
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Measured: Baseline and Week 6
Change From Baseline in Serum Lipocalin-2 at Week 22
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Measured: Baseline and Week 22
Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Measured: Baseline and Week 6
Change From Baseline in REG3-A at Week 22
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Measured: Baseline and Week 22
Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.
Measured: Baseline and Week 6 or 22

Secondary outcomes (2)

Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Measured: Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Measured: Baseline, Week 6, Week 22

Timeline

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

28 Nov 201228 Sep 2015

First posted9 May 2011 (estimated)
Study start28 Nov 2012
Primary completion28 Sep 2015
Study completion28 Sep 2015

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 DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349920
Sponsor's protocol ID: P08143
Other IDs: 2011-000517-40, MK-2155-195
Status last verified: Sep 2018
First submitted: 5 May 2011
Last updated: 15 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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
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Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
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Enrolling by invitationPhase 4
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All Crohn Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT01349920
Acronym / sponsor ID: P08143
Conditions: Crohn Disease
Keywords: biological markers, endoscopy, gastrointestinal
Study type: Observational
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 28 Nov 2012 (actual)
Primary completion: 28 Sep 2015 (actual)
Study completion: 28 Sep 2015 (actual)
First posted: 9 May 2011 (estimated)
Results: Posted 28 Sep 2016

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: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Infliximab 5 mg/kg	–	Drug: InfliximabInfliximab treatment and endoscopy.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.

Key inclusion criteria (7 listed)

Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
History of colonic involvement verified by prior endoscopy or radiography
Indicated for treatment with infliximab according to current best medical practice
Body Mass Index (BMI) between 15 kg/m^2 and 35 kg/m^2
Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception

Key exclusion criteria (20 listed)

Pregnancy, intention to become pregnant, or breastfeeding
Evidence of a colon unaffected by CD
Indication for surgery
Perianal disease likely to interfere with study participation
Presence of a stoma or history of colectomy

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

Interventions

Intervention	Type	Arms
InfliximabAlso: Remicade, SCH 215596, MK-2155Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.	Drug	Infliximab 5 mg/kg

Primary outcome

Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
Time frame: Baseline and Week 6
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Change From Baseline in CDEIS Blinded Score at Week 22
Time frame: Baseline and Week 22
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6
Time frame: Baseline and Week 6
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Change From Baseline in Serum hsCRP at Week 22
Time frame: Baseline and Week 22
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Change From Baseline in Stool Calprotectin at Week 6
Time frame: Baseline and Week 6
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Change From Baseline in Stool Calprotectin at Week 22
Time frame: Baseline and Week 22
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Change From Baseline in Serum Lipocalin-2 at Week 6
Time frame: Baseline and Week 6
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Change From Baseline in Serum Lipocalin-2 at Week 22
Time frame: Baseline and Week 22
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6
Time frame: Baseline and Week 6
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Change From Baseline in REG3-A at Week 22
Time frame: Baseline and Week 22
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
Time frame: Baseline and Week 6 or 22
To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.

2 secondary outcomes

Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
Time frame: Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
Time frame: Baseline, Week 6, Week 22

Results and safety

Results posted to the registry on 28 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infliximab 5mg/kg	15	15

Primary outcome: Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: Score on a scale

Measure	Infliximab 5 mg/kg n = 13
Value	-4.8 (4.2)

Population analysed: Participants who had a blinded CDEIS score at both baseline and at Week 6.

Primary outcome: Change From Baseline in CDEIS Blinded Score at Week 22

Time frame: Baseline and Week 22. Mean (Standard Deviation). Unit: Score on a scale

Measure	Infliximab 5 mg/kg n = 12
Value	-7.3 (5.5)

Population analysed: Participants who had a blinded CDEIS score at both baseline and at Week 22.

Primary outcome: Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: mg/L

Measure	Infliximab 5 mg/kg n = 12
Value	-38.1 (30.4)

Population analysed: Participants with measurements for hsCRP at both baseline and at Week 6.

Primary outcome: Change From Baseline in Serum hsCRP at Week 22

Time frame: Baseline and Week 22. Mean (Standard Deviation). Unit: mg/L

Measure	Infliximab 5 mg/kg n = 14
Value	-28.0 (39.3)

Population analysed: Participants with measurements for hsCRP at both baseline and at Week 22.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-study	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
Infliximab 5mg/kg	2 of 15 (13.3%)	13 of 15 (86.7%)	Not reported
Post-study	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Crohn Disease

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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RecruitingObservational study
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Enrolling by invitationPhase 4
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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease, run by Merck Sharp & Dohme LLC.

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 7 inclusion and 20 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 15 Oct 2018. 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 28 Sep 2016). 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?

Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6 (time frame: Baseline and Week 6). The study lists 11 primary outcomes in all. 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 NCT01349920.

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 15 Oct 2018.