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Rituximab in the Treatment of Graves' Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150111
First Posted: September 8, 2005
Last Update Posted: October 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  Purpose

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, TSH-receptor antibodies, anti-TPO)


Condition Intervention Phase
Graves´ Disease Thyroid Associated Ophthalmopathy Drug: Methimazole Drug: Rituximab Biological: Immunization with various vaccines Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: B Cell Depletion With the Anti-CD20 Monoclonal Antibody Rituximab in the Treatment of Graves' Disease

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Time to relapse after cessation of treatment judged at 1, 3, 6, 9 and 12 months post cessation.

Secondary Outcome Measures:
  • Safety
  • Changes in autoantibodies (monthly)
  • Immunological changes (monthly)
  • Response to vaccines (1 month post-immunization)

Estimated Enrollment: 20
Study Start Date: June 2003
Estimated Study Completion Date: October 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Graves´ disease
  • Adequate anticonception in women.

Exclusion Criteria:

  • Performance status >2
  • Previous rituximab treatment
  • Immunosuppressive treatment
  • Serious concomitant disease
  • Active infections
  • Pregnancy / breast feeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150111


Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Department of Hematology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Daniel El-Fassi, MD Odense University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00150111     History of Changes
Other Study ID Numbers: 014
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: October 6, 2006
Last Verified: October 2006

Keywords provided by Odense University Hospital:
Graves disease
thyroid
ophthalmopathy
autoimmunity
B lymphocyte depletion
rituximab
immunization

Additional relevant MeSH terms:
Graves Disease
Graves Ophthalmopathy
Eye Diseases
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Eye Diseases, Hereditary
Rituximab
Vaccines
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents