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Trial of Rituximab for Graves' Ophthalmopathy

NCT00595335 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-01-01

Study results available
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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.

Conditions

  • Thyroid-associated Ophthalmopathy

Interventions

DRUG

Rituximab

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

DRUG

Saline

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Rebecca Bahn

    lead OTHER

Principal Investigators

  • Rebecca S Bahn, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595335 on ClinicalTrials.gov