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A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
Drug: ABT-874
Drug: Methotrexate
Registration Number
NCT00679731
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Brief Summary

This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.

Detailed Description

This study is only being conducted in the EU and Canada

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
317
Inclusion Criteria
  • Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above
Read More
Exclusion Criteria
  • Previous exposure to anti-IL 12
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AABT-874ABT-874
BMethotrexateMethotrexate
Primary Outcome Measures
NameTimeMethod
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52Week 52
Secondary Outcome Measures
NameTimeMethod
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24Week 24
Changes from Baseline in the DLQI total score at Week 24Week 24
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52Week 52
Changes from Baseline in the DLQI total score at Week 52Week 52

Trial Locations

Locations (43)

Site Reference ID/Investigator# 12763

🇦🇹

Vienna, Austria

Site Reference ID/Investigator# 13104

🇨🇦

Barrie, Canada

Site Reference ID/Investigator# 8185

🇸🇪

Stockholm, Sweden

Site Reference ID/Investigator# 11661

🇫🇷

Creteil, France

Site Reference ID/Investigator# 8025

🇩🇪

Berlin, Germany

Site Reference ID/Investigator# 8032

🇩🇪

Hamburg, Germany

Site Reference ID/Investigator# 8027

🇩🇪

Kiel, Germany

Site Reference ID/Investigator# 11504

🇫🇷

Nice, France

Site Reference ID/Investigator# 12401

🇬🇧

Aberdeen, United Kingdom

Site Reference ID/Investigator# 8362

🇪🇸

Valencia, Spain

Site Reference ID/Investigator# 13163

🇪🇸

Seville, Spain

Site Reference ID/Investigator# 8551

🇮🇹

Rome, Italy

Site Reference ID/Investigator# 13223

🇨🇦

Quebec City, Canada

Site Reference ID/Investigator# 8030

🇫🇮

Helsinki, Finland

Site Reference ID/Investigator# 13461

🇬🇷

Thessaloniki, Greece

Site Reference ID/Investigator# 8034

🇬🇧

Manchester, United Kingdom

Site Reference ID/Investigator# 13221

🇨🇦

Waterloo, Canada

Site Reference ID/Investigator# 8026

🇫🇮

Turku, Finland

Site Reference ID/Investigator# 9583

🇮🇹

Modena, Italy

Site Reference ID/Investigator# 10963

🇫🇷

Toulouse Cedex 9, France

Site Reference ID/Investigator# 8019

🇩🇪

Muenster, Germany

Site Reference ID/Investigator# 11864

🇨🇦

Hamilton, Canada

Site Reference ID/Investigator# 12381

🇮🇹

Milan, Italy

Site Reference ID/Investigator# 10702

🇪🇸

Madrid, Spain

Site Reference ID/Investigator# 8035

🇩🇪

Munich, Germany

Site Reference ID/Investigator# 13481

🇪🇸

Barcelona, Spain

Site Reference ID/Investigator# 11381

🇩🇰

Aarhus, Denmark

Site Reference ID/Investigator# 11841

🇩🇰

Copenhagen NV, Denmark

Site Reference ID/Investigator# 11161

🇫🇷

Paris, France

Site Reference ID/Investigator# 8023

🇩🇪

Tuebingen, Germany

Site Reference ID/Investigator# 13161

🇨🇦

Halifax, Canada

Site Reference ID/Investigator# 8024

🇩🇪

Frankfurt am Main, Germany

Site Reference ID/Investigator# 9904

🇦🇹

Graz, Austria

Site Reference ID/Investigator# 11001

🇦🇹

Vienna, Austria

Site Reference ID/Investigator# 8363

🇳🇱

Nijmegen, Netherlands

Site Reference ID/Investigator# 10203

🇨🇭

Geneva 14, Switzerland

Site Reference ID/Investigator# 8022

🇧🇪

Brussels, Belgium

Site Reference ID/Investigator# 13422

🇬🇷

Athens, Greece

Site Reference ID/Investigator# 13462

🇬🇷

Athens, Greece

Site Reference ID/Investigator# 8033

🇫🇮

Kuopio, Finland

Site Reference ID/Investigator# 8021

🇫🇮

Lahti, Finland

Site Reference ID/Investigator# 11701

🇳🇱

Amsterdam, Netherlands

Site Reference ID/Investigator# 8020

🇨🇭

Zurich, Switzerland

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