IBDNCT04205734
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
An observational study of IBD, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- IBD
- What is being tested?
- MTX Assessment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2021to 31 Dec 2024
- 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 1 year to 21 years
- All sexes
- Child, Adult
Study population: Patients with IBD being treated with methotrexate (oral or subcutaneous)
Who may be able to join
- IBD
- Methotrexate Therapy
Who cannot join
- Inability to provide relevant samples
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- IBD
- Being tested
- MTX Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX AssessmentDiagnostic test
Measurement of Methotrexate Polyglutamate levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Methotrexate Polyglutamate Level
Measurement of Methotrexate Polyglutamate Levels
Measured: Samples will collected within 16 weeks of consent.
Secondary outcomes (2)
The correlation between Methotrexate Polyglutamate Levels and Lab Parameters
Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin
Measured: Samples will collected within 16 weeks of consent.
The correlation between Methotrexate Polyglutamate Levels and Clinical History
Do Methotrexate Polyglutamate Levels Predict Clinical Outcome as Measured by Disease Activity Indices, including PUCAI for ulcerative colitis and PCDAI for patients with Crohn Disease
Measured: Samples will collected within 16 weeks of consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start30 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: COVID Restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Web, Boston Children's Hospital
- Investigators
- PAUL A RUFO, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205734
- Sponsor's protocol ID
- IRB-P00028947
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04205734
- Acronym / sponsor ID
- IRB-P00028947
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID Restrictions
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Dec 2019 (actual)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with IBD being treated with methotrexate (oral or subcutaneous)
Key inclusion criteria (2 listed)
- IBD
- Methotrexate Therapy
Key exclusion criteria (1 listed)
- Inability to provide relevant samples
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 |
|---|---|---|
| MTX AssessmentMeasurement of Methotrexate Polyglutamate levels. | Diagnostic test | – |
Primary outcome
Methotrexate Polyglutamate Level
Time frame: Samples will collected within 16 weeks of consent.
Measurement of Methotrexate Polyglutamate Levels
2 secondary outcomes
The correlation between Methotrexate Polyglutamate Levels and Lab Parameters
Time frame: Samples will collected within 16 weeks of consent.
The correlation between Methotrexate Polyglutamate Levels and Clinical History
Time frame: Samples will collected within 16 weeks of consent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
PAUL A RUFO principal investigator
Boston Children's Hospital
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 IBD, run by Boston Children's Hospital 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 2 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: paused, as of the sponsor's last update on 10 Oct 2023. 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?
Methotrexate Polyglutamate Level (time frame: Samples will collected within 16 weeks of consent.). 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 10 Oct 2023.