Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101829
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2005-01-13
Brief Title:
Anti-CD20 Antibody Therapy for Sjogrens Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label One Arm Phase I Safety Study of Anti-CD20 Antibody Rituximab Rituxan Therapy in the Treatment of Primary Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Sjogrens syndrome SS Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma Rituximab may also help people with SS a disease of the immune system However the safety of rituximab in SS patients must first be established
Detailed Description:
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-Hodgkins 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None