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NCT02316691 · ClinicalTrials.gov registry record
B-cell Depletion Therapy With Rituximab for Thyroid Eye Disease
A clinical trial, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- 2
- Enrollment target
NCT02316691: Clinical Trial study, sponsored by University of Pittsburgh.
NCT02316691 is a clinical trial that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316691 was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially, the relapse rate is high and about 75% require further surgery despite initial response. Although the natural history of TED is associated with spontaneous remissions after about 1 to 3 years, many irreversible serious ophthalmic and orbital complications can arise during this time. Therefore, there is a need for improved intervention strategies in the early active inflammatory phase of TED, to avoid progression to the cicatricial stage where disease manifestations can only be addressed in a rehabilitative fashion. The primary immunopathogenesis of Graves' disease is considered to be activation of B cells that then produce autoantibody against thyrotropin receptors in the thyroid (TRAb). Like in many autoimmune diseases, the inflammatory CD4+ T cell subset known as Th17 cells is also increased in blood of patients with active Graves' disease; the putative Th17 cytokine, IL-17, is also increased in serum and tears of TED patients. There is also an emerging pathogenic role for Th17 cells that co-express the chemokine receptor CXCR5 and drive autoantibody production. The contribution of Th17 cells to TED is not well defined. This study is an observational, longitudinal, prospective study of patients receiving treatment for thyroid eye disease.
Primary Outcome
Remission of symptoms and disease activity by 26 weeks after the first dose of medication. Subjects will be followed for one year to assess relapse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-11 |
Why NCT02316691 stopped before completion
NCT02316691 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02316691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02316691 about?
NCT02316691 is a clinical study titled "B-cell Depletion Therapy With Rituximab for Thyroid Eye Disease". Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially, the relapse rate is high and about 75% require further surgery despite initial response. Although the natural hist...
What is the current status of trial NCT02316691?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2016-01. Estimated completion is 2019-11.
Who is sponsoring clinical trial NCT02316691?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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