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NCT Number: NCT00679731

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 9904, Graz, Austria

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About this study

This study is only being conducted in the EU and Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-874

Drug

200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection

methotrexate

Drug

5.0 to 25 mg weekly

Primary outcomes

  1. Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24

    Time frame: Week 24

  2. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24

    Time frame: Week 24

  3. Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52

    Time frame: Week 52

  4. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52

    Time frame: Week 52

Secondary outcomes

  1. Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24

    Time frame: Week 24

  2. Changes from Baseline in the DLQI total score at Week 24

    Time frame: Week 24

  3. Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52

    Time frame: Week 52

  4. Changes from Baseline in the DLQI total score at Week 52

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 19, 2008
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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