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

January 22, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is only being conducted in the EU and Canada

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Site Reference ID/Investigator# 9904
      • Vienna, Austria, 1090
        • Site Reference ID/Investigator# 11001
      • Vienna, Austria, A-1030
        • Site Reference ID/Investigator# 12763
  • Belgium
      • Brussels, Belgium, 1200
        • Site Reference ID/Investigator# 8022
  • Canada
      • Barrie, Canada, L4M 6L2
        • Site Reference ID/Investigator# 13104
      • Halifax, Canada, B3H 0A2
        • Site Reference ID/Investigator# 13161
      • Hamilton, Canada, L8N 1V6
        • Site Reference ID/Investigator# 11864
      • Quebec City, Canada, G1V 4X7
        • Site Reference ID/Investigator# 13223
      • Waterloo, Canada, N2J 1C4
        • Site Reference ID/Investigator# 13221
  • Denmark
      • Aarhus, Denmark, 8000
        • Site Reference ID/Investigator# 11381
      • Copenhagen NV, Denmark, 2400
        • Site Reference ID/Investigator# 11841
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Site Reference ID/Investigator# 8030
      • Kuopio, Finland, 70211
        • Site Reference ID/Investigator# 8033
      • Lahti, Finland, 15850
        • Site Reference ID/Investigator# 8021
      • Turku, Finland, 20521
        • Site Reference ID/Investigator# 8026
  • France
      • Creteil, France, 94010
        • Site Reference ID/Investigator# 11661
      • Nice, France, 06200
        • Site Reference ID/Investigator# 11504
      • Paris, France, 75475
        • Site Reference ID/Investigator# 11161
      • Toulouse Cedex 9, France, 31059
        • Site Reference ID/Investigator# 10963
  • Germany
      • Berlin, Germany, 10117
        • Site Reference ID/Investigator# 8025
      • Frankfurt am Main, Germany, 60590
        • Site Reference ID/Investigator# 8024
      • Hamburg, Germany, D-20354
        • Site Reference ID/Investigator# 8032
      • Kiel, Germany, 24105
        • Site Reference ID/Investigator# 8027
      • Muenster, Germany, 48149
        • Site Reference ID/Investigator# 8019
      • Munich, Germany, D-80337
        • Site Reference ID/Investigator# 8035
      • Tuebingen, Germany, 72076
        • Site Reference ID/Investigator# 8023
  • Greece
      • Athens, Greece, 161 21
        • Site Reference ID/Investigator# 13422
      • Athens, Greece, 16121
        • Site Reference ID/Investigator# 13462
      • Thessaloniki, Greece, 54643
        • Site Reference ID/Investigator# 13461
  • Italy
      • Milan, Italy, 20161
        • Site Reference ID/Investigator# 12381
      • Modena, Italy, 41100
        • Site Reference ID/Investigator# 9583
      • Rome, Italy, 00133
        • Site Reference ID/Investigator# 8551
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Site Reference ID/Investigator# 11701
      • Nijmegen, Netherlands, 6500 HB
        • Site Reference ID/Investigator# 8363
  • Spain
      • Barcelona, Spain, 08916
        • Site Reference ID/Investigator# 13481
      • Madrid, Spain, 28006
        • Site Reference ID/Investigator# 10702
      • Seville, Spain, 41009
        • Site Reference ID/Investigator# 13163
      • Valencia, Spain, 46014
        • Site Reference ID/Investigator# 8362
  • Sweden
      • Stockholm, Sweden, 171 76
        • Site Reference ID/Investigator# 8185
  • Switzerland
      • Geneva 14, Switzerland, 1211
        • Site Reference ID/Investigator# 10203
      • Zurich, Switzerland, 8091
        • Site Reference ID/Investigator# 8020
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZR
        • Site Reference ID/Investigator# 12401
      • Manchester, United Kingdom, M6 8HD
        • Site Reference ID/Investigator# 8034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ABT-874
Drug: ABT-874
200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection
Active Comparator: B
Methotrexate
Drug: Methotrexate
5.0 to 25 mg weekly

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Chair: Martin Kaul, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-255
  • 2007-004687-47 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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