Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Phase 2

Completed

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

• Registration Number: NCT00646386
• Lead Sponsor: Abbott

Brief Summary

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-04
• 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: 315

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
A	adalimumab	-
B	placebo for adalimumab	-

Primary Outcome Measures

Name	Time	Method
ACR20	Week 12
Adverse Events	Throughout study participation
Sharp Score	Week 24

Secondary Outcome Measures

Name	Time	Method
ACR20, 50, 70	Weeks 12, 24
Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI	Weeks 12 and 24