Rituximab in the Treatment of Graves' Disease - Full Text View

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00150111

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 I Phase II

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:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome Help Me Understand Genetics

MedlinePlus related topics: Eye Diseases Thyroid Diseases

Drug Information available for: Methimazole Rituximab

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:

El Fassi D, Nielsen CH, Hasselbalch HC, Hegedus L. The rationale for B lymphocyte depletion in Graves' disease. Monoclonal anti-CD20 antibody therapy as a novel treatment option. Eur J Endocrinol. 2006 May;154(5):623-32. Review.

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 February 13, 2012