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NCT03591770 · ClinicalTrials.gov registry record · Phase 4
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
A Phase 4 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT03591770 is a Phase 4 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 15 participants.
The verdict
NCT03591770, a Phase 4 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their underlying disease. Patients with UC are also often treated with immunosuppressants, and research has shown that IBD patients on immunosuppressants have an impaired immune response to vaccination in comparison to immunocompetent controls. Because UC patients are often treated with immunosuppressants, the live HZ vaccine was not recommended in these patients. Shingrix, however, is a new inactivated vaccine recently approved by the FDA for prevention of HZ in adults age 50 and older, and Shingrix should be safe to administer in IBD patients because it does not contain live HZ virus. Data on efficacy of the Shingrix vaccine also appears promising in immunocompromised patients. Tofacitinib citrate (Xeljanz), an immunosuppressant that works by inhibiting the Janus kinase pathway, is currently approved for treatment of certain inflammatory diseases such as rheumatoid arthritis and psoriasis. The drug is currently awaiting FDA-approval for use in moderate-to-severe UC but has been used off-label in various settings. Notably, tofacitinib was associated with an increased risk of HZ in patients with rheumatoid arthritis and psoriasis. The research hypothesis is that UC patients on tofacitinib will mount an adequate response and that the response will be slightly diminished compared to non-immunosuppressed IBD patients, comparable to those on anti-tumor necrosis alpha (anti-TNF) monotherapy, and superior to those on anti-TNF therapy in combination with a thiopurine. Strong cell mediated immunity is shown to prevent reactivation of HZ, and demonstrating a robust immune response to Shingrix may serve as a surrogate for a reduced risk of developing shingles and might alleviate prescribers' concerns regarding the use of tofacitinib. The results will als
Interventions
- BIOLOGICAL SHINGRIX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2024-07-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03591770
The ClinicalTrials.gov registry entry for NCT03591770 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SHINGRIX is the first listed.
NCT03591770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03591770 about?
NCT03591770 is a clinical study titled "Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib". Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their underlying disease. Patients with UC are also often treated with immun...
What is the current status of trial NCT03591770?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2019-07-31. Estimated completion is 2024-07-04.
What interventions are being tested in trial NCT03591770?
The interventions under investigation include: SHINGRIX (BIOLOGICAL).
Who is sponsoring clinical trial NCT03591770?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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