Working... Menu

Rituximab in the Treatment of Graves' Disease

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. Identifier: NCT00150111
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 6, 2006
Information provided by:
Odense University Hospital

Brief Summary:


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 or disease Intervention/treatment Phase
Graves´ Disease Thyroid Associated Ophthalmopathy Drug: Methimazole Drug: Rituximab Biological: Immunization with various vaccines Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
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
Study Start Date : June 2003
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00150111

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Daniel El-Fassi, MD Odense University Hospital

Layout table for additonal information Identifier: NCT00150111     History of Changes
Other Study ID Numbers: 014
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: October 2006

Keywords provided by Odense University Hospital:
Graves disease
B lymphocyte depletion

Additional relevant MeSH terms:
Layout table for MeSH terms
Graves Disease
Eye Diseases
Graves Ophthalmopathy
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents