|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | B Cell Depletion With the Anti-CD20 Monoclonal Antibody Rituximab in the Treatment of Graves' Disease |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Department of Hematology, Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Denmark, Funen | |
| Department of Endocrinology, Odense University Hospital | |
| Odense, Funen, Denmark, 5000 | |
| Principal Investigator: | Daniel El-Fassi, MD | Odense University Hospital |
More Information
| Study ID Numbers: | 014 |
| Study First Received: | September 6, 2005 |
| Last Updated: | October 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00150111 History of Changes |
| Health Authority: | Denmark: National Board of Health |
|
Graves disease thyroid ophthalmopathy autoimmunity |
B lymphocyte depletion rituximab immunization |
|
Antithyroid Agents Methimazole Goiter Autoimmune Diseases Immunologic Factors Graves Ophthalmopathy Rituximab Hormone Antagonists Eye Diseases Graves Disease Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases |
Hormones Antibodies, Monoclonal Antibodies Graves' Disease Eye Diseases, Hereditary Orbital Diseases Endocrinopathy Antirheumatic Agents Thyroid Diseases Hyperthyroidism Immunoglobulins |
|
Antithyroid Agents Goiter Methimazole Autoimmune Diseases Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Graves Ophthalmopathy Hormone Antagonists Eye Diseases Physiological Effects of Drugs |
Graves Disease Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Pharmacologic Actions Exophthalmos Therapeutic Uses Eye Diseases, Hereditary Orbital Diseases Antirheumatic Agents Thyroid Diseases Hyperthyroidism |
