Trial of Rituximab for Graves' Ophthalmopathy

Conditions

• Thyroid-associated Ophthalmopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
• Saline — DRUG
  Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
• Methylprednisolone — DRUG
  Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.

Study Details

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.

Key Dates

Start date

Apr 30, 2008

Status verified

Dec 2015

Primary completion

Mar 31, 2013

Completion

Sep 30, 2013

Study Design

Enrollment

25 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
• Placebo Comparator: Placebo
  Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.

Primary Outcome Measure

Change in Clinical Activity Score (CAS) [ Time Frame: baseline, 6 months after the first infusion ]

Locations (1)

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