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ClinicalTrials.gov ID

NCT05014555

Lead Sponsor

GI AllianceOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

400Estimated

Last Update Posted

Jun 18, 2023Actual

Start Date

Jul 5, 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 2024Estimated

Official Title

Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease

Brief Summary

The aim of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19 vaccine.

• Inflammatory Bowel Diseases

• COVID-19 Vaccine

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

A patient will be eligible for inclusion in this study if he or she meets all the following criteria:

• Patient is between the ages of 18-85 years, inclusive

• 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

Observational Model

Cohort

Time Perspective

Cross-Sectional

Lead Sponsor

GI AllianceOTHER

Collaborators

Janssen, LPINDUSTRY

University of Wisconsin, MadisonOTHER

Mayo ClinicOTHER

dana.reed-alexander@gialliance.com225-927-1190 ext. 7805

andrew.black@gialliance.com817-562-0039