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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Disposition First Submitted: 2011-08-24
• Disposition First Submitted QC: 2011-08-24
• Disposition First Posted: 2011-08-29
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-29

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

Exclusion Criteria

• Previous exposure to anti-IL 12

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ABT-874	ABT-874
B	Methotrexate	Methotrexate

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24	Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24	Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52	Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52	Week 52

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24	Week 24
Changes from Baseline in the DLQI total score at Week 24	Week 24
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52	Week 52
Changes from Baseline in the DLQI total score at Week 52	Week 52

Trial Locations

Locations (43)

Site Reference ID/Investigator# 9904; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 11001; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 12763; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 8022; 🇧🇪 Brussels, Belgium

Site Reference ID/Investigator# 13104; 🇨🇦 Barrie, Canada

Site Reference ID/Investigator# 13161; 🇨🇦 Halifax, Canada

Site Reference ID/Investigator# 11864; 🇨🇦 Hamilton, Canada

Site Reference ID/Investigator# 13223; 🇨🇦 Quebec City, Canada

Site Reference ID/Investigator# 13221; 🇨🇦 Waterloo, Canada

Site Reference ID/Investigator# 11381; 🇩🇰 Aarhus, Denmark

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