Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051662
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-01-14
Brief Title:
Safety Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
Sponsor:
XOMA US LLC
Organization:
XOMA US LLC
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Study to Determine the Safety Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2004-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 whether a humanized monoclonal antibody efalizumab is safe and effective in the treatment of psoriatic arthritis PsA
Detailed Description:
A phase II randomized double-blind placebo-controlled study to
1 Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis PsA
2 Evaluate the safety tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
1 Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis PsA
2 Evaluate the safety tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
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