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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ABT-874

Methotrexate

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

ABT-874

Methotrexate

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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

Changes from Baseline in the DLQI total score at Week 24

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

Changes from Baseline in the DLQI total score at Week 52

Full Information

NCT ID

NCT00679731

First Posted

May 15, 2008

Last Updated

January 22, 2013

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT00679731

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

317 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

ABT-874

Arm Title

Arm Type

Active Comparator

Arm Description

Methotrexate

Intervention Type

Drug

Intervention Name(s)

ABT-874

Intervention Description

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

Intervention Name(s)

Methotrexate

Intervention Description

5.0 to 25 mg weekly

Primary Outcome Measure Information:

Title

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

Time Frame

Week 24

Title

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

Time Frame

Week 24

Title

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

Time Frame

Week 52

Title

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

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

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

Time Frame

Week 24

Title

Changes from Baseline in the DLQI total score at Week 24

Time Frame

Week 24

Title

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

Time Frame

Week 52

Title

Changes from Baseline in the DLQI total score at Week 52

Time Frame

Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Kaul, MD

Organizational Affiliation

AbbVie

Official's Role

Study Chair

Facility Information:

Facility Name

Site Reference ID/Investigator# 9904

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Site Reference ID/Investigator# 11001

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Site Reference ID/Investigator# 12763

City

Vienna

ZIP/Postal Code

A-1030

Country

Austria

Facility Name

Site Reference ID/Investigator# 8022

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Site Reference ID/Investigator# 13104

City

Barrie

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Site Reference ID/Investigator# 13161

City

Halifax

ZIP/Postal Code

B3H 0A2

Country

Canada

Facility Name

Site Reference ID/Investigator# 11864

City

Hamilton

ZIP/Postal Code

L8N 1V6

Country

Canada

Facility Name

Site Reference ID/Investigator# 13223

City

Quebec City

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Site Reference ID/Investigator# 13221

City

Waterloo

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Site Reference ID/Investigator# 11381

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Site Reference ID/Investigator# 11841

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Site Reference ID/Investigator# 8030

City

Helsinki

ZIP/Postal Code

00029 HUS

Country

Finland

Facility Name

Site Reference ID/Investigator# 8033

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

Site Reference ID/Investigator# 8021

City

Lahti

ZIP/Postal Code

15850

Country

Finland

Facility Name

Site Reference ID/Investigator# 8026

City

Turku

ZIP/Postal Code

20521

Country

Finland

Facility Name

Site Reference ID/Investigator# 11661

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Site Reference ID/Investigator# 11504

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

Site Reference ID/Investigator# 11161

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Site Reference ID/Investigator# 10963

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Site Reference ID/Investigator# 8025

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Site Reference ID/Investigator# 8024

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Site Reference ID/Investigator# 8032

City

Hamburg

ZIP/Postal Code

D-20354

Country

Germany

Facility Name

Site Reference ID/Investigator# 8027

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Site Reference ID/Investigator# 8019

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Site Reference ID/Investigator# 8035

City

Munich

ZIP/Postal Code

D-80337

Country

Germany

Facility Name

Site Reference ID/Investigator# 8023

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Site Reference ID/Investigator# 13422

City

Athens

ZIP/Postal Code

161 21

Country

Greece

Facility Name

Site Reference ID/Investigator# 13462

City

Athens

ZIP/Postal Code

16121

Country

Greece

Facility Name

Site Reference ID/Investigator# 13461

City

Thessaloniki

ZIP/Postal Code

54643

Country

Greece

Facility Name

Site Reference ID/Investigator# 12381

City

Milan

ZIP/Postal Code

20161

Country

Italy

Facility Name

Site Reference ID/Investigator# 9583

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

Site Reference ID/Investigator# 8551

City

Rome

ZIP/Postal Code

00133

Country

Italy

Facility Name

Site Reference ID/Investigator# 11701

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Site Reference ID/Investigator# 8363

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Facility Name

Site Reference ID/Investigator# 13481

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Site Reference ID/Investigator# 10702

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Site Reference ID/Investigator# 13163

City

Seville

ZIP/Postal Code

41009

Country

Spain

Facility Name

Site Reference ID/Investigator# 8362

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Site Reference ID/Investigator# 8185

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Site Reference ID/Investigator# 10203

City

Geneva 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Site Reference ID/Investigator# 8020

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Site Reference ID/Investigator# 12401

City

Aberdeen

ZIP/Postal Code

AB25 2ZR

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 8034

City

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22169986

Citation

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.

Results Reference

derived

PubMed Identifier

22029980

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial