Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis

Phase 1

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: NCT00051662
• Lead Sponsor: XOMA (US) LLC

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

Study Timeline

• Study First Submitted: 2003-01-14
• Study First Submitted QC: 2003-01-15
• Study First Posted: 2003-01-16
• Study Completion: 2004-02
• Status Verified: 2004-09
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP