Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000401
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
1999-11-03
Brief Title:
Oral Collagen for Rheumatoid Arthritis
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatoid arthritis RA is an autoimmune disease characterized by swelling and inflammation of the joints In RA the immune system attacks a persons own cells inside joints eventually leading to joint damage and disability This study will determine if oral bovine type II collagen bovine CII will lead to decreased joint inflammation in RA patients
Detailed Description:
RA is an inflammatory disease that causes pain swelling stiffness and loss of function in the joints The study will evaluate the effects of using oral bovine CII on RA patients by assessing the levels of inflammation markers such as interferon gamma IFN-gamma interleukin-10 IL-10 and transforming growth factor beta TGF-beta This study is a multicenter clinical trial to be conducted at the University of Tennessee Memphis the lead center and the West Tennessee Medical Specialty Clinic a collaborating site
Patients enrolled will be allowed to continue a constant dose of disease-modifying anti-rheumatic drugs DMARDs and prednisone less than or equal to 75 mgday Patients will be randomly assigned to one of two groups The low dose group will receive 30 mcg daily for 10 weeks then 50 mcg daily for 10 weeks followed by 70 mcg daily for 10 more weeks the high dose group will receive 90 mcg daily for 10 weeks then 100 mcg daily for 10 weeks followed by 130 mcg daily for 10 more weeks Blood will be collected at screening and at Weeks 10 20 and 30 Blood will be analyzed for indicators of inflammation
Note this trial is no longer being conducted as an intervention trial Accrual has been discontinued although patients previously enrolled are still being followed
Patients enrolled will be allowed to continue a constant dose of disease-modifying anti-rheumatic drugs DMARDs and prednisone less than or equal to 75 mgday Patients will be randomly assigned to one of two groups The low dose group will receive 30 mcg daily for 10 weeks then 50 mcg daily for 10 weeks followed by 70 mcg daily for 10 more weeks the high dose group will receive 90 mcg daily for 10 weeks then 100 mcg daily for 10 weeks followed by 130 mcg daily for 10 more weeks Blood will be collected at screening and at Weeks 10 20 and 30 Blood will be analyzed for indicators of inflammation
Note this trial is no longer being conducted as an intervention trial Accrual has been discontinued although patients previously enrolled are still being followed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-037 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR045255 |
| R01AR045255 | NIH | None | None |