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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Takeda | INDUSTRY |
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The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:
Participants in this study will:
Eligible participants will receive vedolizumab through an IV ("infusion") at week 0, then week 2, then week 6. Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year. At each visit, participants will be asked about their collagenous gastritis symptoms and any changes in their health or medications.
Blood samples will be collected from participants at every vedolizumab infusion. Some of these samples will be collected for safety purposes, some will be collected to monitor CG progression, and some will be collected for research purposes.
During the screening period and a few months after beginning treatment, the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participant's CG. An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract (the esophagus, stomach, and part of the small intestine). During the procedure, biopsies will be collected to monitor CG and for research purposes. All participants will be given medication to make them comfortable throughout the duration of the procedure, which lasts approximately 10 to 30 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 300mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Biological | Administered over 30 minute infusion at MGH main campus |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in symtpoms | Change in symptoms associated with collagenous gastritis after 12 weeks of vedolizumab treatment, measured via patient-reported symptom questionnaire scores collected at each visit. Response is defined as a decrease of at least 1 Grade (DAIDS) in the most severe symptom reported at baseline. Surveys will be scored from 0 to 38, with higher scores indicating more severe symptoms and lower outcomes indicating no symptoms or more mild symptoms. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response durability | Durability of symptomatic response to vedolizumab over the first year of treatment will be measured via patient-reported symptom questionnaire scores collected at each visit. Surveys will be scored from 0 to 38, with higher scores indicating more severe symptoms and lower outcomes indicating no symptoms or more mild symptoms. | 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic response in gastric mucosa | Immunologic response in the gastric mucosa will be assessed via flow cytometry and scRNA-seq of gastric biopsies and, if available, compared to baseline (within 1 year) gastric biopsies | 54 Weeks |
| Immunologic response in peripheral blood |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
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| Histologic response | Histologic response to vedolizumab will be assessed by comparing gastric histology from on-treatment biopsies and, if available, compared to baseline (within 1 year) gastric histology | 12 weeks (+/- 4 weeks) |
| Incidence of treatment-emergent adverse events (safety) | Safety will be assessed by adverse event (AE) rates throughout the first year of treatment. Severity will be graded according to the DAIDS grading table (v2.1). | 54 Weeks |
Immunologic response in peripheral blood will be assessed via flow cytometry and scRNA-seq of peripheral blood mononuclear cells as well as serum proteomics |
| 54 Weeks |