Clinical trial NCT00679731: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
timeFrame: Week 24
measure: The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24
timeFrame: Week 24
measure: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52
timeFrame: Week 52
measure: The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24
timeFrame: Week 24
measure: Changes from Baseline in the DLQI total score at Week 24
timeFrame: Week 24
measure: Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52
timeFrame: Week 52
measure: Changes from Baseline in the DLQI total score at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 9904
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 11001
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 12763
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 8022
city: Barrie
country: Canada
facility: Site Reference ID/Investigator# 13104
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 13161
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 11864
city: Quebec City
country: Canada
facility: Site Reference ID/Investigator# 13223
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 13221
city: Aarhus
country: Denmark
facility: Site Reference ID/Investigator# 11381
city: Copenhagen NV
country: Denmark
facility: Site Reference ID/Investigator# 11841
city: Helsinki
country: Finland
facility: Site Reference ID/Investigator# 8030
city: Kuopio
country: Finland
facility: Site Reference ID/Investigator# 8033
city: Lahti
country: Finland
facility: Site Reference ID/Investigator# 8021
city: Turku
country: Finland
facility: Site Reference ID/Investigator# 8026
city: Creteil
country: France
facility: Site Reference ID/Investigator# 11661
city: Nice
country: France
facility: Site Reference ID/Investigator# 11504
city: Paris
country: France
facility: Site Reference ID/Investigator# 11161
city: Toulouse Cedex 9
country: France
facility: Site Reference ID/Investigator# 10963
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 8025
city: Frankfurt am Main
country: Germany
facility: Site Reference ID/Investigator# 8024
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 8032
city: Kiel
country: Germany
facility: Site Reference ID/Investigator# 8027
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 8019
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 8035
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 8023
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 13422
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 13462
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 13461
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 12381
city: Modena
country: Italy
facility: Site Reference ID/Investigator# 9583
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 8551
city: Amsterdam
country: Netherlands
facility: Site Reference ID/Investigator# 11701
city: Nijmegen
country: Netherlands
facility: Site Reference ID/Investigator# 8363
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 13481
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 10702
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 13163
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 8362
city: Stockholm
country: Sweden
facility: Site Reference ID/Investigator# 8185
city: Geneva 14
country: Switzerland
facility: Site Reference ID/Investigator# 10203
city: Zurich
country: Switzerland
facility: Site Reference ID/Investigator# 8020
city: Aberdeen
country: United Kingdom
facility: Site Reference ID/Investigator# 12401
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 8034
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_CHAIR
References:
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.
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.