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Rituximab in the Treatment of Graves' Disease

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00150111
First received: September 6, 2005
Last updated: October 5, 2006
Last verified: October 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 6, 2005
Last Updated: October 5, 2006
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Eye Diseases
Graves Disease
Thyroid Diseases
Graves Ophthalmopathy
Exophthalmos
Orbital Diseases
Goiter
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Eye Diseases, Hereditary
 Methimazole
Rituximab
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Immunologic Factors
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013