Trial of Rituximab for Graves' Ophthalmopathy

Phase 2/3 Completed 25 enrolled Rebecca Bahn National Center for Research Resources (NCRR) · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-04
Primary completion: 2013-03
Completion: 2013-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Rituximab vs Placebo; p = 0.73; t-test, 2 sided NCT00595335 ↗

paper No differences were found in the proportions of patients showing CAS improvement at 24 weeks (25% placebo; 31% RTX, P = .75) PMID 25343233 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	100 mg	Intravenous