Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

Phase 3

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: NCT00195689
• Lead Sponsor: Abbott

Brief Summary

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-28
• Last Update Posted: 2007-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Subject completed study M02-518 or M02-570

Exclusion Criteria

• Subject prematurely discontinued study M02-518 or M02-570

  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
Disease progression measurements
FACTIT Fatigue Scale

Secondary Outcome Measures

Name	Time	Method
Clinical response indicators
Patient reported outcomes

Trial Locations

Locations (1)

Global Medical Information-Abbott Laboratories; 🇺🇸 Abbott Park, Illinois, United States