NCT00679731

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2008

Geographic Reach
14 countries

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.6 years

First QC Date

May 15, 2008

Last Update Submit

January 22, 2013

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

A

EXPERIMENTAL

ABT-874

Drug: ABT-874

B

ACTIVE COMPARATOR

Methotrexate

Drug: Methotrexate

Interventions

ABT-874DRUG

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

A
MethotrexateDRUG

5.0 to 25 mg weekly

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above

You may not qualify if:

  • Previous exposure to anti-IL 12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Site Reference ID/Investigator# 9904

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 11001

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 12763

Vienna, A-1030, Austria

Location

Site Reference ID/Investigator# 8022

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 13104

Barrie, L4M 6L2, Canada

Location

Site Reference ID/Investigator# 13161

Halifax, B3H 0A2, Canada

Location

Site Reference ID/Investigator# 11864

Hamilton, L8N 1V6, Canada

Location

Site Reference ID/Investigator# 13223

Québec, G1V 4X7, Canada

Location

Site Reference ID/Investigator# 13221

Waterloo, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 11381

Aarhus, 8000, Denmark

Location

Site Reference ID/Investigator# 11841

Copenhagen NV, 2400, Denmark

Location

Site Reference ID/Investigator# 8030

Helsinki, 00029 HUS, Finland

Location

Site Reference ID/Investigator# 8033

Kuopio, 70211, Finland

Location

Site Reference ID/Investigator# 8021

Lahti, 15850, Finland

Location

Site Reference ID/Investigator# 8026

Turku, 20521, Finland

Location

Site Reference ID/Investigator# 11661

Créteil, 94010, France

Location

Site Reference ID/Investigator# 11504

Nice, 06200, France

Location

Site Reference ID/Investigator# 11161

Paris, 75475, France

Location

Site Reference ID/Investigator# 10963

Toulouse, 31059, France

Location

Site Reference ID/Investigator# 8025

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 8024

Frankfurt am Main, 60590, Germany

Location

Site Reference ID/Investigator# 8032

Hamburg, D-20354, Germany

Location

Site Reference ID/Investigator# 8027

Kiel, 24105, Germany

Location

Site Reference ID/Investigator# 8035

Munich, D-80337, Germany

Location

Site Reference ID/Investigator# 8019

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 8023

Tübingen, 72076, Germany

Location

Site Reference ID/Investigator# 13422

Athens, 161 21, Greece

Location

Site Reference ID/Investigator# 13462

Athens, 16121, Greece

Location

Site Reference ID/Investigator# 13461

Thessaloniki, 54643, Greece

Location

Site Reference ID/Investigator# 12381

Milan, 20161, Italy

Location

Site Reference ID/Investigator# 9583

Modena, 41100, Italy

Location

Site Reference ID/Investigator# 8551

Rome, 00133, Italy

Location

Site Reference ID/Investigator# 11701

Amsterdam, 1105 AZ, Netherlands

Location

Site Reference ID/Investigator# 8363

Nijmegen, 6500 HB, Netherlands

Location

Site Reference ID/Investigator# 13481

Barcelona, 08916, Spain

Location

Site Reference ID/Investigator# 10702

Madrid, 28006, Spain

Location

Site Reference ID/Investigator# 13163

Seville, 41009, Spain

Location

Site Reference ID/Investigator# 8362

Valencia, 46014, Spain

Location

Site Reference ID/Investigator# 8185

Stockholm, 171 76, Sweden

Location

Site Reference ID/Investigator# 10203

Geneva, 1211, Switzerland

Location

Site Reference ID/Investigator# 8020

Zurich, 8091, Switzerland

Location

Site Reference ID/Investigator# 12401

Aberdeen, AB25 2ZR, United Kingdom

Location

Site Reference ID/Investigator# 8034

Manchester, M6 8HD, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 22169986DERIVED

  • 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.

    PMID: 22029980DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

briakinumabMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Martin Kaul, MD

    AbbVie

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

CA(5)DK(2)GR(3)ES(4)BE(1)CH(2)DE(7)GB(2)NL(2)SE(1)IT(3)AU(3)FI(4)FR(4)