Crohn DiseaseNCT04655729
Biomarkers to Predict and Monitor Response to Infliximab
An observational study of Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients… Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 20 years
- All sexes
- Child, Adult
Study population: Patients 3-20 years old diagnosed with Crohn's Disease starting infliximab
Who may be able to join
- Patients between the ages of 3-20 years old
- Patient starting infliximab or infliximab biosimilar,
- Patients naïve to TNF inhibitor
Who cannot join
- Patients receiving infliximab or biosimilar infusions at home
- Patients already undergone significant bowel surgery relating to their Crohn's.
Trial locations and contacts
1 site in 1 country.
United States1 site
MassGeneral for Children
Boston, Massachusetts, 02114
About this study
Official title: Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan
The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.
Read the detailed description
Prospective, observational study will enroll 120 unique pediatric Crohn's disease patients between the ages of 3-20 years among multiple sites. Patients will be naïve to TNF inhibitor. If patient is going to start infliximab or infliximab biosimilar, patient may be enrolled in study. Study length will be from commencement of infliximab until the infusion visit given at least 1 year after initiation. During the study, if the patient fails infliximab or biosimilar, they will be complete study once failure is indicated and discontinued on infliximab or biosimilar. Patients may be on concurrent IBD therapy such as antibiotics, mesalamines, immunomodulators and may continue in study if non-standard induction schedule or changes made during induction or maintenance to dose or frequency. Excluded patients will be those receiving infliximab or biosimilar infusions at home due to need for blood collection at time of infusion, on systemic corticosteroids (topical preparations such as budesonide are allowed), and those who have already undergone significant bowel surgery relating to their Crohn's.
Study visits will take place in conjunction with previously scheduled routine clinic visits or infusion visits. At initial study visit, demographics, medical and surgical history, PARIS classification, PCDAI, weight and height, fecal calprotectin, labs, EGD and colonoscopy report and pathology report, cross-sectional imaging reports and concurrent medications will be obtained and entered. Parameters measured at each study visit will include any obtained labs, weight and height, PARIS classification, PCDAI, infliximab dose (mg/kg) and dose interval. There will be four study visits throughout the course of 1 year after initiating infliximab. At these four visits, blood will be obtained in PAXgene tubes for RNA analysis and serum for banking for SOMAscan analysis.
- Conditions
- Crohn Disease
- Being tested
- Infliximab
- 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
Blood collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort)
Run 120 pediatric Crohn's patients' serum at baseline, week 14, and week 54 on SOMAscan; Develop predictor model for protein biomarkers that predict response from baseline serum
Measured: 2 years
Secondary outcomes (2)
Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan.
Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan.
Measured: 2 years
Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab
Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start18 Nov 2019
- Primary completion30 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Harland S. Winter, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655729
- Sponsor's protocol ID
- 2019p002322
- Status last verified
- Sep 2024
- First submitted
- 30 Nov 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan
- ClinicalTrials.gov ID
- NCT04655729
- Acronym / sponsor ID
- 2019p002322
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.
Detailed description
Prospective, observational study will enroll 120 unique pediatric Crohn's disease patients between the ages of 3-20 years among multiple sites. Patients will be naïve to TNF inhibitor. If patient is going to start infliximab or infliximab biosimilar, patient may be enrolled in study. Study length will be from commencement of infliximab until the infusion visit given at least 1 year after initiation. During the study, if the patient fails infliximab or biosimilar, they will be complete study once failure is indicated and discontinued on infliximab or biosimilar. Patients may be on concurrent IBD therapy such as antibiotics, mesalamines, immunomodulators and may continue in study if non-standard induction schedule or changes made during induction or maintenance to dose or frequency. Excluded patients will be those receiving infliximab or biosimilar infusions at home due to need for blood collection at time of infusion, on systemic corticosteroids (topical preparations such as budesonide are allowed), and those who have already undergone significant bowel surgery relating to their Crohn's.
Study visits will take place in conjunction with previously scheduled routine clinic visits or infusion visits. At initial study visit, demographics, medical and surgical history, PARIS classification, PCDAI, weight and height, fecal calprotectin, labs, EGD and colonoscopy report and pathology report, cross-sectional imaging reports and concurrent medications will be obtained and entered. Parameters measured at each study visit will include any obtained labs, weight and height, PARIS classification, PCDAI, infliximab dose (mg/kg) and dose interval. There will be four study visits throughout the course of 1 year after initiating infliximab. At these four visits, blood will be obtained in PAXgene tubes for RNA analysis and serum for banking for SOMAscan analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients 3-20 years old diagnosed with Crohn's Disease starting infliximab
Key inclusion criteria (3 listed)
- Patients between the ages of 3-20 years old
- Patient starting infliximab or infliximab biosimilar,
- Patients naïve to TNF inhibitor
Key exclusion criteria (2 listed)
- Patients receiving infliximab or biosimilar infusions at home
- Patients already undergone significant bowel surgery relating to their Crohn's.
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 |
|---|---|---|
| InfliximabBlood collection | Drug | – |
Primary outcome
Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort)
Time frame: 2 years
Run 120 pediatric Crohn's patients' serum at baseline, week 14, and week 54 on SOMAscan; Develop predictor model for protein biomarkers that predict response from baseline serum
2 secondary outcomes
Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan.
Time frame: 2 years
Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 2 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.