Open Label Continuation Study in Moderate to Severe Psoriasis

Phase 3

Completed

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: ABT-874

• Registration Number: NCT00626002
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-29
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-10-05
• Disposition First Submitted QC: 2012-10-05
• Disposition First Posted: 2012-10-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2301

Inclusion Criteria

• Having participated in a preceding ABT-874 clinical trial for ABT-874
• Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion Criteria

• Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABT-874	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.	Visit (12 weeks)
Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.	Visit (12 weeks)
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.	Visit (12 weeks)
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study	Visit (12 weeks)

Trial Locations

Locations (152)

Site Reference ID/Investigator# 7496; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 8438; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 7522; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 7774; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 7435; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 7933; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 7234; 🇺🇸 Bakersfield, California, United States

Site Reference ID/Investigator# 8249; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 7332; 🇺🇸 Irvine, California, United States

Site Reference ID/Investigator# 7239; 🇺🇸 Los Angeles, California, United States

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