NCT00595335|CompletedPhase 2/3ResultsDMC
Trial of Rituximab for Graves' Ophthalmopathy
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy
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Sponsor study identifier
Secondary identifiers
interventional
25
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2008
Actual (reported)January 16, 2008
Actual (reported)April 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)September 2013
Actual (reported)June 3, 2014
Actual (reported)Change in Clinical Activity Score (CAS)
The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.
baseline, 6 months after the first infusion
Failure Rate
6 months after first infusion, 12 months after first infusion
Change in Disease Severity
baseline, 6 months after first infusion
Change in Proptosis
baseline, 12 months after first infusion
Change in Lid Fissure
baseline, 6 months after first infusion
Change in Extraocular Motility
baseline, 6 months after first infusion, 12 months after first infusion
Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Mayo Clinic
Rochester, Minnesota, 55905, United States
Stan MN, Garrity JA, Carranza Leon BG, Prabin T, Bradley EA, Bahn RS. Randomized controlled trial of rituximab in patients with Graves' orbitopathy. J Clin Endocrinol Metab. 2015 Feb;100(2):432-41. doi: 10.1210/jc.2014-2572. Epub 2014 Oct 24.
Rebecca S Bahn, MD
Mayo Clinic
25 participants (actual enrollment reported by the registry).
First Submitted
January 1, 2008
First Posted
January 16, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
January 1, 2016
Results First Posted
June 3, 2014
Record last verified: 2015-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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