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Suggestions within category "Digestive Health & Liver Disease"


2 Study Matches

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

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.
Freddy Caldera
All
18 Years to 85 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05014555
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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
Inflammatory Bowel Diseases, Other
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An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.
Freddy Caldera
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05369832
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Inclusion Criteria:

• A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
• Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
• Report of a previous colonoscopy that documents extent of disease
Exclusion Criteria:

• Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
• Extensive colonic resection or current stoma
• Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply
Colitis, Ulcerative, Other
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