Pediatric Inflammatory Bowel DiseaseNCT01490528
Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience
An observational study of Pediatric Inflammatory Bowel Disease, run by Cedars-Sinai Medical Center.
Trial summary
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Inflammatory Bowel Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to not given
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent
Who may be able to join
- All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent
Who cannot join
- not exposed to infliximab
Trial locations and contacts
No sites are listed yet.
Marla Dubinsky, MD contact
About this study
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children.
The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab.
Read more
The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab.
Safety outcomes will focus on frequency of malignancies, infections and immunogenecity
- Conditions
- Pediatric Inflammatory Bowel Disease
- Keywords
- Pediatric IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
Measured: 10 years
Secondary outcomes (2)
Frequency of concomitant immunomodulator use in children on infliximab
Measured: 10 years
Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Inflammatory Bowel DiseaseStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marla Dubinsky, Cedars-Sinai Medical Center
- Investigators
- Marla Dubinsky, Principal investigator, Cedar Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490528
- Sponsor's protocol ID
- REMICADEIBD4008
- Status last verified
- Dec 2011
- First submitted
- 7 Dec 2011
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience
- ClinicalTrials.gov ID
- NCT01490528
- Acronym / sponsor ID
- REMICADEIBD4008
- Conditions
- Pediatric Inflammatory Bowel Disease
- Keywords
- Pediatric IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- First posted
- 13 Dec 2011 (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.
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children.
The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab.
The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab.
Safety outcomes will focus on frequency of malignancies, infections and immunogenecity
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent
Key inclusion criteria (1 listed)
- All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent
Key exclusion criteria (1 listed)
- not exposed to infliximab
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
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
Time frame: 10 years
2 secondary outcomes
Frequency of concomitant immunomodulator use in children on infliximab
Time frame: 10 years
Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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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.
Marla Dubinsky, MD contact
Marla Dubinsky principal investigator
Cedar Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Inflammatory Bowel Disease, run by Cedars-Sinai Medical Center.
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 1 inclusion and 1 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 14 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marla Dubinsky, MD (dubinskym@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab (time frame: 10 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 14 Dec 2011.