Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442611
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2007-03-01
Brief Title:
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis Scleroderma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Systemic sclerosis scleroderma is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options We hypothesize that treatment with abatacept a new therapy recently approved for the treatment of rheumatoid arthritis may reduce the progression of skin thickening and fibrosis in people with scleroderma
Detailed Description:
Systemic sclerosis is an autoimmune connective tissue disease of unknown etiology characterized by progressive fibrosis of the skin and internal organs vascular damage and autoantibody production Although the disease is relatively rare it is associated with considerable morbidity and mortality There have been improvements in survival over the past few decades however this has been related to better management of vascular manifestations of disease including renal crisis pulmonary hypertension gastroesophageal reflux disease and Raynauds phenomenon Clinical studies of disease modifying therapies for cutaneous disease to date have been relatively unsuccessful
Although the etiology of the disease remains unknown several observations support the role of activated T cells in both the blood and skin of affected patients Abatacept a recombinant fusion protein that blocks T cell activation has recently been approved by the FDA for rheumatoid arthritis We hypothesize that inhibition of T cell activation with abatacept may be efficacious in the treatment of patients with diffuse systemic sclerosis This is a randomized double-blinded placebo-controlled clinical trial of abatacept versus placebo in patients with diffuse systemic sclerosis Changes in validated measures of skin thickness and disease activity over 6-months of treatment will be compared between patients receiving abatacept and those receiving placebo Patients will be randomized 21 to receive abatacept
The protocol was amended during the study and the outcome measures Change in Serum Autoantibody Profile and Change in Serum Cytokine Profile were changed to exploratory outcomes
Although the etiology of the disease remains unknown several observations support the role of activated T cells in both the blood and skin of affected patients Abatacept a recombinant fusion protein that blocks T cell activation has recently been approved by the FDA for rheumatoid arthritis We hypothesize that inhibition of T cell activation with abatacept may be efficacious in the treatment of patients with diffuse systemic sclerosis This is a randomized double-blinded placebo-controlled clinical trial of abatacept versus placebo in patients with diffuse systemic sclerosis Changes in validated measures of skin thickness and disease activity over 6-months of treatment will be compared between patients receiving abatacept and those receiving placebo Patients will be randomized 21 to receive abatacept
The protocol was amended during the study and the outcome measures Change in Serum Autoantibody Profile and Change in Serum Cytokine Profile were changed to exploratory outcomes
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