Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
---|---|
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00595335 |
This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells (B lymphocytes CD20 positive) involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.
Condition | Intervention | Phase |
---|---|---|
Thyroid-Associated Ophthalmopathy |
Drug: Rituximab Drug: IV saline |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Rituximab
15 patients will receive 2 infusions of rituximab (1000 mg IV), two weeks apart
|
2: Placebo Comparator |
Drug: IV saline
15 patients will receive 2 infusions if saline IV, 2 weeks apart
|
Detailed Description: Before any treatment is given, careful eye and thyroid physical examinations will be performed and the patients will have several thyroid blood tests, a test to count the white cells in the blood, and a CT scan of the head and eyes. A thyroid ultrasound will be performed at the end of the first visit. A close-up photograph of the face will be taken and patients will be given a short questionnaire about how their eyes are feeling and how the eye disease is affecting their quality of life. Each study subject will receive either 2 infusions of rituximab (each 1000 mg; given 2 weeks apart) or 2 intravenous infusions of saline. Patients will return to Rochester 2 weeks after the first intravenous infusion in order to receive the second infusion. They will then return to Rochester four more times; 2 months apart for the first 3 return visits (weeks 8, 16 and 24 following the first infusion) and 6 months later (approximately 52 weeks following the first infusion) for the final visit to have the same blood tests performed. The CT scan will be repeated at 52 weeks. The thyroid ultrasound will be repeated at the 24 weeks and 52 weeks visits. Patients will be assigned to one of these two groups in a random manner (like flipping a coin) and neither they nor the physicians will know until the study is completed whether they received saline or the study drug.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebecca S Bahn, MD | 507 284-0051 | bahn.rebecca@mayo.edu |
Contact: Marius N Stan, MD | 507 284-0051 | stan.marius@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Rebecca S Bahn, MD 507-284-0051 bahn.rebecca@mayo.edu | |
Contact: Marius N Stan, MD 507 284-0051 stan.marius@mayo.edu | |
Principal Investigator: Rebecca S Bahn, MD | |
Sub-Investigator: Marius N Stan, MD |
Principal Investigator: | Rebecca S Bahn, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Rebecca S Bahn ) |
Study ID Numbers: | DK77814, NIH RO1DK077814-01 |
Study First Received: | January 1, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00595335 |
Health Authority: | United States: Food and Drug Administration |
Thyroid-associated ophthalmopathy Rituximab Proptosis |
Goiter Autoimmune Diseases Graves Ophthalmopathy Rituximab Eye Diseases Graves Disease Endocrine System Diseases |
Graves' disease Eye Diseases, Hereditary Orbital Diseases Endocrinopathy Thyroid Diseases Hyperthyroidism |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions Exophthalmos |