Inflammatory Bowel DiseasesNCT02027727
Individualized Infiximab Dosing-Proof of Concept Study
An observational study of Inflammatory Bowel Diseases, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients. Read more about this study
- Who is it for?
- Ages 6 to 23 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Mar 2018
- 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 6 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Males and females patients age 6 to 23
Who may be able to join
- Males and females on IFX
- Patients with IBD
- Age 6-23
- Able to obtain consent
Who cannot join
- Not receiving infliximab
- On 10 mg/kg of IFX
- Not able to obtain consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.
Read the detailed description
Our aims are:
- to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients.
- to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab.
Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- No Intervention
- Keywords
- inflammatory bowel disease, infliximab, trough level, crohn's disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
no intervention- tihs is an observational study
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention- this is an observational study of patients receiving Infliximab. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infliximab level and clinical remission at 54 weeks
Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 54
Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis.
Fischer exact testing will be done to determine what detectable IFX level (week 6, week 8 or week 14) is most associated with week 54 clinical remission.
Wilcoxon rank sum test will be performed to determine the median level that is most associated with week 54 clinical remission.
Regression tree analysis will be performed to determine the optimal infliximab level cut point that predicts week 54 clinical remission.
Measured: 54 weeks
Infliximab level and clinical remission at 30 weeks
Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 30
Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis.
Measured: 30 weeks
Secondary outcomes (1)
Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles
Secondary outcomes
- Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles for all patients with at least 6 months in between levels Analysis: Bland Altman test will be used to quantify the agreement between the two methods: Software pk model vs actual measured pk profiles
- Comparison of software selected dose regimens with actual dose regimens for cost and overall drug exposure (AUC and Cmax)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2017
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namita Singh, M.D., Cedars-Sinai Medical Center
- Investigators
- Namita Singh, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027727
- Sponsor's protocol ID
- Infiximab Dosing
- Status last verified
- Jul 2017
- First submitted
- 9 Dec 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Infiximab Dosing-Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02027727
- Acronym / sponsor ID
- Infiximab Dosing
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel disease, infliximab, trough level, crohn's disease, ulcerative colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2017 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 6 Jan 2014 (estimated)
- 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 purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.
Detailed description
Our aims are:
- to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients.
- to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab.
Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | – | Other: No InterventionNo intervention- this is an observational study of patients receiving Infliximab. |
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Males and females patients age 6 to 23
Key inclusion criteria (4 listed)
- Males and females on IFX
- Patients with IBD
- Age 6-23
- Able to obtain consent
Key exclusion criteria (3 listed)
- Not receiving infliximab
- On 10 mg/kg of IFX
- Not able to obtain consent
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 |
|---|---|---|
| No Interventionno intervention- tihs is an observational study | Other | No intervention |
Primary outcome
Infliximab level and clinical remission at 54 weeks
Time frame: 54 weeks
Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 54 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis. Fischer exact testing will be done to determine what detectable IFX level (week 6, week 8 or week 14) is most associated with week 54 clinical remission. Wilcoxon rank sum test will be performed to determine the median level that is most associated with week 54 clinical remission. Regression tree analysis will be performed to determine the optimal infliximab level cut point that predicts week 54 clinical remission.
Infliximab level and clinical remission at 30 weeks
Time frame: 30 weeks
Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 30 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis.
1 secondary outcome
Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
Namita Singh, MD principal investigator
Cedars-Sinai Medical Center
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 Inflammatory Bowel Diseases, run by Cedars-Sinai Medical Center 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. 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?
Results are not available in the source record.
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?
Infliximab level and clinical remission at 54 weeks (time frame: 54 weeks). The study lists 2 primary outcomes in all. 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 19 Jul 2017.