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

NCT ID: NCT00679731

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-11-30

Brief Summary

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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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Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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Detailed Description

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This study is only being conducted in the EU and Canada

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

ABT-874

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

B

Methotrexate

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

5.0 to 25 mg weekly

Interventions

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ABT-874

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

Intervention Type DRUG

Methotrexate

5.0 to 25 mg weekly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Kaul, MD

Role: STUDY_CHAIR

AbbVie

Locations

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Site Reference ID/Investigator# 9904

Graz, , Austria

Site Status

Site Reference ID/Investigator# 11001

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 12763

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 8022

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 13104

Barrie, , Canada

Site Status

Site Reference ID/Investigator# 13161

Halifax, , Canada

Site Status

Site Reference ID/Investigator# 11864

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 13223

Québec, , Canada

Site Status

Site Reference ID/Investigator# 13221

Waterloo, , Canada

Site Status

Site Reference ID/Investigator# 11381

Aarhus, , Denmark

Site Status

Site Reference ID/Investigator# 11841

Copenhagen NV, , Denmark

Site Status

Site Reference ID/Investigator# 8030

Helsinki, , Finland

Site Status

Site Reference ID/Investigator# 8033

Kuopio, , Finland

Site Status

Site Reference ID/Investigator# 8021

Lahti, , Finland

Site Status

Site Reference ID/Investigator# 8026

Turku, , Finland

Site Status

Site Reference ID/Investigator# 11661

Créteil, , France

Site Status

Site Reference ID/Investigator# 11504

Nice, , France

Site Status

Site Reference ID/Investigator# 11161

Paris, , France

Site Status

Site Reference ID/Investigator# 10963

Toulouse, , France

Site Status

Site Reference ID/Investigator# 8025

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 8024

Frankfurt am Main, , Germany

Site Status

Site Reference ID/Investigator# 8032

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 8027

Kiel, , Germany

Site Status

Site Reference ID/Investigator# 8035

Munich, , Germany

Site Status

Site Reference ID/Investigator# 8019

Münster, , Germany

Site Status

Site Reference ID/Investigator# 8023

Tübingen, , Germany

Site Status

Site Reference ID/Investigator# 13422

Athens, , Greece

Site Status

Site Reference ID/Investigator# 13462

Athens, , Greece

Site Status

Site Reference ID/Investigator# 13461

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 12381

Milan, , Italy

Site Status

Site Reference ID/Investigator# 9583

Modena, , Italy

Site Status

Site Reference ID/Investigator# 8551

Rome, , Italy

Site Status

Site Reference ID/Investigator# 11701

Amsterdam, , Netherlands

Site Status

Site Reference ID/Investigator# 8363

Nijmegen, , Netherlands

Site Status

Site Reference ID/Investigator# 13481

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 10702

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 13163

Seville, , Spain

Site Status

Site Reference ID/Investigator# 8362

Valencia, , Spain

Site Status

Site Reference ID/Investigator# 8185

Stockholm, , Sweden

Site Status

Site Reference ID/Investigator# 10203

Geneva, , Switzerland

Site Status

Site Reference ID/Investigator# 8020

Zurich, , Switzerland

Site Status

Site Reference ID/Investigator# 12401

Aberdeen, , United Kingdom

Site Status

Site Reference ID/Investigator# 8034

Manchester, , United Kingdom

Site Status

Countries

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Austria Belgium Canada Denmark Finland France Germany Greece Italy Netherlands Spain Sweden Switzerland United Kingdom

References

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Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243. No abstract available.

Reference Type DERIVED
PMID: 22169986 (View on PubMed)

Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.

Reference Type DERIVED
PMID: 22029980 (View on PubMed)

Other Identifiers

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2007-004687-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-255

Identifier Type: -

Identifier Source: org_study_id

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