Open Label Continuation Study in Moderate to Severe Psoriasis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00626002

Purpose

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 III

MedlinePlus related topics: Psoriasis

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase 3, Multicenter, Open-Label Continuation Study to Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit. [ Time Frame: 12 wks ] [ 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: 12 wks ] [ 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: 12 wks ] [ Designated as safety issue: No ]
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-874 100mg ABT-874 administered SQ every 4 wks for approximately 160 weeks

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

Abbott

Investigators

Study Director:

Stephen Yoo, MD

Abbott

More Information

Responsible Party:	Abbott ( Nicky Mayber )
Study ID Numbers:	M10-016
Study First Received:	February 22, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00626002
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009