Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00525213
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2007-09-04
Brief Title:
Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate
Sponsor:
OxyPharma
Organization:
OxyPharma
Study Overview
Official Title:
A Phase II Randomised Double-blind International Multicentre Placebo-controlled Dose-ranging Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Stable Methotrexate
Status:
COMPLETED
Status Verified Date:
2009-08
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:
ROBUST
Brief Summary:
The primary objective of this study is to evaluate the efficacy ACR20 of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA
Detailed Description:
Rheumatoid arthritis RA is a common chronic disabling systemic autoimmune disease in which inflammation of the joint lining synovium occurs when the bodys tissues are attacked by the immune system The joint inflammation begins in the synovium and slowly destroys the cartilage narrowing the joint and eventually damaging the bone A large amount of inflammatory mediators or rheumatoid factors are synthesised in the joint which accelerate proliferation and differentiation of immune cells further to amplify the autoimmune reaction A widely accepted model has emerged in which the presence of inflammation in established RA is driven by interactions between T cells macrophages and fibroblasts in an abnormal microenvironment
Rheumatoid arthritis has an annual incidence of approximately 02 per 1000 in males and 04 per 1000 in females In general higher rates have been reported in the USA than in European populations The incidence of RA increases with age until the mid 70s A prevalence of 05-1 is reported in diverse populations world-wide
Treatments for RA focus on relieving pain reducing inflammation slowing or stopping joint damage and improving patients well being and ability to function Current therapies include non-steroidal anti-inflammatory drugs NSAIDs which target the clinical features of the disease to alleviate the pain and swelling that accompany RA disease-modifying anti-rheumatic drugs DMARDs which target the actual cause of the disease and biological agents which are genetically engineered to target and modify the autoimmune response Non-steroidal anti-inflammatory drugs are effective in managing the symptoms of RA but are limiting as they cannot suppress progression of the disease First line treatment on confirmation of RA is the use of DMARDs supported by pain relief medication
Biologic agents TNF antagonists anti B-cell agents and anti-interleukins have proven effective in RA symptoms management TNF antagonists have become an important therapeutic option in the treatment of advanced RA
Rheumatoid arthritis has an annual incidence of approximately 02 per 1000 in males and 04 per 1000 in females In general higher rates have been reported in the USA than in European populations The incidence of RA increases with age until the mid 70s A prevalence of 05-1 is reported in diverse populations world-wide
Treatments for RA focus on relieving pain reducing inflammation slowing or stopping joint damage and improving patients well being and ability to function Current therapies include non-steroidal anti-inflammatory drugs NSAIDs which target the clinical features of the disease to alleviate the pain and swelling that accompany RA disease-modifying anti-rheumatic drugs DMARDs which target the actual cause of the disease and biological agents which are genetically engineered to target and modify the autoimmune response Non-steroidal anti-inflammatory drugs are effective in managing the symptoms of RA but are limiting as they cannot suppress progression of the disease First line treatment on confirmation of RA is the use of DMARDs supported by pain relief medication
Biologic agents TNF antagonists anti B-cell agents and anti-interleukins have proven effective in RA symptoms management TNF antagonists have become an important therapeutic option in the treatment of advanced RA
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