Status:
COMPLETED
Rituximab in the Treatment of Graves' Disease
Lead Sponsor:
Odense University Hospital
Conditions:
Graves´ Disease
Thyroid Associated Ophthalmopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Aim: In a phase II pilot study encompassing 20 patients with Graves' disease to evaluate the effect of rituximab: 1\. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH...
Detailed Description
Background Rituximab is a chimeric murine/human anti-CD20 monoclonal antibody which was originally introduced in the clinic years ago for the treatment of malignant lymphomas. The antibody is an IgG1...
Eligibility Criteria
Inclusion
- Graves´ disease
- Adequate anticonception in women.
Exclusion
- Performance status \>2
- Previous rituximab treatment
- Immunosuppressive treatment
- Serious concomitant disease
- Active infections
- Pregnancy / breast feeding.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00150111
Start Date
June 1 2003
End Date
October 1 2006
Last Update
October 6 2006
Active Locations (2)
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1
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
2
Department of Hematology, Odense University Hospital
Odense, Denmark, 5000