Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Phase 3

Completed

• Conditions: Arthritis; Psoriatic
• Interventions: Drug: placebo for adalimumab; Drug: adalimumab

• Registration Number: NCT00646178
• Lead Sponsor: Abbott

Brief Summary

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-03
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Moderate to severe PsA
• Inadequate response to DMARD therapy
• Corticosteroid stable dose <=10 mg QD
• DMARDs must have been taken for 3 months and stable dose for 4 weeks
• MTX maximum dose = <=30 mg/week
• Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria

• No other active skin disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo for adalimumab	-
A	adalimumab	-

Primary Outcome Measures

Name	Time	Method
ACR20	Week 12
Adverse Events	Throughout the Study

Secondary Outcome Measures

Name	Time	Method
ACR50/70	Week 12
Modified Psoriatic Arthritis Response Criteria	Week 12
Multiple QOL Assessments	Week 12
Physicians Global Assessment for Psoriasis	Week 12