Rituximab in the Treatment of Graves' Disease

NCT00150111 | Completed Phase 1

• 1 other identifier: 014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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, TSH-receptor antibodies, anti-TPO)

Conditions

Graves´ Disease; Thyroid Associated Ophthalmopathy

Keywords

Graves disease; thyroid; ophthalmopathy; autoimmunity; B lymphocyte depletion; rituximab; immunization

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• Safety

• Changes in autoantibodies (monthly)

• Immunological changes (monthly)

• Response to vaccines (1 month post-immunization)

Interventions

Methimazole DRUG

Rituximab DRUG

Immunization with various vaccines BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Graves´ disease
• Adequate anticonception in women.

You may not qualify if:

• Performance status \>2
• Previous rituximab treatment
• Immunosuppressive treatment
• Serious concomitant disease
• Active infections
• Pregnancy / breast feeding.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (2)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Department of Hematology, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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. doi: 10.1530/eje.1.02140.

  PMID: 16645007 BACKGROUND

MeSH Terms

Conditions

Graves Disease; Graves Ophthalmopathy; Thyroid Diseases; Eye Diseases; Autoimmune Diseases

Interventions

Methimazole; Rituximab; Immunization

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Goiter; Endocrine System Diseases; Hyperthyroidism; Immune System Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Daniel El-Fassi, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: June 1, 2003
• Study Completion: October 1, 2006
• Last Updated: October 6, 2006

Record last verified: 2006-10

Locations

DK (2)