NCT05960162

Brief Summary

The aim of this study is to analyze the relationship between 90K serum levels measured at baseline and after induction in IBD patient undergoing infliximab therapy, in order to clarify the role of serum 90K as an adjuvant biomarker for IBD patients in the active phase. Furthermore, the study aims to evaluate the clinical usefulness of this new biomarker in the management of IBD patients undergoing infliximab therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 18, 2023

Last Update Submit

July 18, 2023

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • evaluate the clinical usefulness of this new biomarker in the

    12 months

Interventions

90KDIAGNOSTIC_TEST

Blood test

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be 50 patients were recently diagnosed with Inflammatory Bowel Disease (IBD), Crohn's disease (CD) and Ulcerative Colitis (UC), undergoing the anti-TNF drug infliximab. Infliximab therapy will be administered intravenously initially at a dose of 5 mg/kg/ dose, and then after two and six weeks after the first dose, and fulfill the following inclusion criteria

You may qualify if:

  • Adult male and female patients aged 18-60 years old.
  • IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.

You may not qualify if:

  • \. Comorbidities (assessed with the Charlson Comorbidity Index). 2. Ongoing immunosuppressive or immunomodulatory therapy. 3. A malignant neoplasm in the last 10 years. 4. Pregnancy or breast feeding. 5. The need for artificial nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of internal medicine

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 25, 2023

Study Start

July 17, 2023

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

July 25, 2023

Record last verified: 2023-07