Individualized Infiximab Dosing-Proof of Concept Study

NCT02027727 | Unknown

• 1 other identifier: Infiximab Dosing
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

inflammatory bowel disease; infliximab; trough level; crohn's disease; ulcerative colitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 weeks

Secondary Outcomes (1)

• Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles

  1 year

Study Arms (1)

No intervention

No intervention- this is an observational study of patients receiving Infliximab.

Other: No Intervention

Interventions

No Intervention OTHER

no intervention- tihs is an observational study

No intervention

Eligibility Criteria

• Age: 6 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Males and females patients age 6 to 23

You may qualify if:

• Males and females on IFX
• Patients with IBD
• Age 6-23
• Able to obtain consent

You may not qualify if:

• Not receiving infliximab
• On 10 mg/kg of IFX
• Not able to obtain consent

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Namita Singh, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Pediatrics IBD Center, Cedars Sinai Med Center

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: January 6, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)