Methotrexate Polyglutamate Measurements in Patients With... | NCT04205734

Studies
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

NCT04205734

Sponsor

Boston Children's Hospital

Status

Suspended

Last Update Posted

Oct 10, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Interventions

MTX Assessment

Countries

United States

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID Restrictions

Expanded Access Info

Start Date

Jan 30, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 17, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 19, 2019Actual

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

Oct 8, 2023

Last Update Posted Date

Oct 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

Detailed Description

This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MTX Assessment	Diagnostic Test	Measurement of Methotrexate Polyglutamate levels.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methotrexate Polyglutamate Level	Measurement of Methotrexate Polyglutamate Levels	Samples will collected within 16 weeks of consent.

Secondary Outcomes

Measure	Description	Time Frame
The correlation between Methotrexate Polyglutamate Levels and Lab Parameters	Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin	Samples will collected within 16 weeks of consent.
The correlation between Methotrexate Polyglutamate Levels and Clinical History

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IBD
Methotrexate Therapy

Exclusion Criteria:

Inability to provide relevant samples

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Patients with IBD being treated with methotrexate (oral or subcutaneous)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PAUL A RUFO	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital		Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided