Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
NCT ID: NCT05014555
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2023-07-05
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group A Non-biologic Group
Participants on treatment regimen of mesalamine monotherapy or thiopurine monotherapy, or corticosteroids.
COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care
Group B Anti-TNF Group
Participants on treatment regimen of maintenance montherapy of infliximab (at least 8 every 8 weeks), golilumamb (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly), or combination therapy of anti-TNF therapy as described above along with either 15mg of methotrexate or azathiprine at least 1.0mg/kg or 6MP 0.5mg/kg.
COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care
Group C Ustekinumab Group
Participants on treatment regimen of ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care
Group D Vedolizumab Group
Participants on vedolizumab monotherapy or combination therapy with methotrexate or azathioprine.
COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care
Interventions
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COVID-19 Vaccine
Three-dose mRNA COVID-19 vaccine per standard of care
Eligibility Criteria
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Inclusion Criteria
* Patient has a history of ulcerative colitis (UC), or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria
* On one of the following treatment regimens for at least three months at the time of immunization and continued same therapy at the time of recruitment. Should be on stable doses defined as: Group A should have taken a dose of medication within the past week; Group B infliximab within the previous 8 weeks, golimumab within the previous 4 weeks, adalimumab within the previous 2 weeks, or certolizumab within the previous 4 weeks; Those on combination therapy in group B will have taken azathioprine or methotrexate within the past week. Group C ustekinumab at least within the previous 4 weeks. Those on combination therapy in group C will have taken azathioprine or methotrexate within the past week; Group D vedolizumab at least within the previous 4 weeks. Those on combination therapy in group D will have taken azathioprine or methotrexate within the past week
* Group A non-biologic group: mesalamine monotherapy or thiopurine monotherapy
* Group B: Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 5mg/kg every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly Combination Therapy Anti- TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg at least 40% of the group; Approximately 40-50% of the group will be combination therapy
* Group C: Ustekinumab on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine
* Group D: Vedolizumab Therapy Group: Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
* Patient received at least two doses of mRNA COVID-19 vaccine per standard of care
A patient will not be eligible for inclusion in this study if he or she meets all the following criteria:
* Patient cannot or will not provide written informed consent
* Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
* Received a COVID-19 booster within the previous 28 days
18 Years
85 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
University of Wisconsin, Madison
OTHER
Mayo Clinic
OTHER
GI Alliance
OTHER
Responsible Party
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Principal Investigators
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Tim Ritter, MD
Role: PRINCIPAL_INVESTIGATOR
GI Alliance
Locations
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Mayo Clinic Jacksonville, FL
Jacksonville, Florida, United States
GI Alliance
Baton Rouge, Louisiana, United States
GI Alliance
Southlake, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CNTO1275IBD4005
Identifier Type: -
Identifier Source: org_study_id
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