Durability and Tolerability of Infliximab in Pediatric In... | NCT01490528

Studies
Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience

NCT01490528

Sponsor

Cedars-Sinai Medical Center

Status

Unknown status

Last Update Posted

Dec 14, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Pediatric Inflammatory Bowel Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 7, 2011

First Submission Date that Met QC Criteria

Dec 9, 2011

First Posted Date

Dec 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab		10 years

Secondary Outcomes

Measure	Description	Time Frame
Frequency of concomitant immunomodulator use in children on infliximab		10 years
Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

not exposed to infliximab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marla Dubinsky, MD	Contact			dubinskym@csmc.edu

Overall Officials

Name	Affiliation	Role
Marla Dubinsky	Cedar Sinai Medical Center	Principal Investigator

Locations

Not provided