Open Label Continuation Study in Moderate to Severe Psoriasis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT00626002

First received: February 22, 2008

Last updated: January 28, 2013

Last verified: January 2013

Purpose

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

Condition	Intervention	Phase
Moderate to Severe Plaque Psoriasis	Drug: ABT-874	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit. [ Time Frame: Visit (12 weeks) ] [ Designated as safety issue: No ]
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. [ Time Frame: Visit (12 weeks) ] [ Designated as safety issue: No ]
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. [ Time Frame: Visit (12 weeks) ] [ Designated as safety issue: No ]
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study [ Time Frame: Visit (12 weeks) ] [ Designated as safety issue: Yes ]

Enrollment:	2301
Study Start Date:	February 2008
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ABT-874 100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks Other Name: briakinumab

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626002

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Chair:

Martin Kaul, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00626002 History of Changes
Other Study ID Numbers:	M10-016, 2007-005955-40
Study First Received:	February 22, 2008
Last Updated:	January 28, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Austria : Federal Ministry for Labour, Health, and Social Affairs Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Greece: National Organization of Medicines Italy: Ethics Committee Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:

Open label

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013