Anti-CD20 Antibody Therapy for Sjogren's Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101829|
Recruitment Status : Completed
First Posted : January 14, 2005
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sjogren's Syndrome||Drug: Rituximab||Phase 1|
SS is the second most common autoimmune disease; it is caused by immune cells attacking and destroying the glands that produce tears and saliva, and occurs more often in women than in men. Currently, there are no established disease-modifying treatments for SS. Traditional treatment strategies for SS primarily address dryness symptoms. Rituximab targets the CD20 antigen on the surface of B cells, and was approved in 1997 for the treatment of patients with low-grade or follicular B-cell non-Hodgkin's lymphoma. In a small study, rituximab was also shown to relieve the symptoms of rheumatoid arthritis. Because SS is associated with the development of B cell-related cancers and rituximab has the potential to treat autoimmune disease, rituximab may alleviate the symptoms of SS. This study will evaluate the safety of rituximab in people with SS.
This study will last 1 year. At 4 and 2 weeks before the start of the study, patients will undergo medical and medication history assessment, a physical exam, blood and urine collection, rheumatologic evaluation, an eye exam, and salivary gland tests. The screening visit 4 weeks before study start will also include an electrocardiogram (ECG), a chest x-ray, and a tuberculosis exam. Patients will receive IV rituximab at study entry and at Week 2; blood collection will occur prior to infusion and post-infusion for pharmacokinetics studies. There will be 6 follow-up study visits that will occur at Weeks 4, 8, 14, 26, 30, and 52. Blood and urine collection; a physical exam; rheumatologic evaluation; and eye, skin, and salivary gland tests will occur at selected study visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's Syndrome|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2009|
Experimental: Rituximab Treatment
Participants will receive rituximab at study entry and at Week 2
1000 mg intravenous infusion
Other Name: Rituxan
- Count of Participants with Rituximab Related Grade 3 or higher AEs [ Time Frame: Throughout study ]The study site will grade the severity of adverse events (AEs) experienced by the study participants according to the criteria set forth in the National Cancer Institute's Common Toxicity Criteria for Adverse Events Version 3.0 (published June 10, 2003).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101829
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-6160|
|Principal Investigator:||Philip L. Cohen, MD||Rheumatology Division, University of Pennsylvania|
|Principal Investigator:||E. William St. Clair, MD||Division of Rheumatology and Immunology, Duke University Medical Center|