CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00595335
NCT00595335Phase 3Completed
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Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy

Rebecca Bahn·interventional·Posted Jan 16, 2008·Updated Jan 1, 2016

In Brief

A Phase 3 clinical trial evaluating Rituximab, Saline, and 1 other intervention for Thyroid-associated Ophthalmopathy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid-associated Ophthalmopathy
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.5 years ago

Interventions

Rituximabdrug

Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.

Salinedrug

Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.

Methylprednisolonedrug

Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.