Collagenous Gastritis
Conditions
Keywords
collagenous gastritis, vedolizumab
Brief summary
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: * Whether vedolizumab can reduce CG symptoms * Whether vedolizumab is safe to take for patients with CG Participants in this study will: * Receive vedolizumab through an IV ("infusion") * Complete a survey at each infusion visit * Have blood collected at each infusion visit * Undergo an endoscopy with biopsy at 2 timepoints
Detailed description
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.
Interventions
BIOLOGICALVedolizumab
Administered over 30 minute infusion at MGH main campus
Sponsors
Massachusetts General Hospital
Dana-Farber Cancer Institute
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 14 or older * Weight of at least 40kg * Has a biopsy-confirmed diagnosis of collagenous gastritis * Agrees to all required study procedures * Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash
Exclusion criteria
* Unable to independently provide informed consent or assent * Allergic to vedolizumab or any of its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symtpoms | 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response durability | 54 Weeks | 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. |
| Histologic response | 12 weeks (+/- 4 weeks) | 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 |
| Incidence of treatment-emergent adverse events (safety) | 54 Weeks | 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). |
Countries
United States
Outcome results
None listed