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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:


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) ]
  • 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) ]
  • 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) ]
  • AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study [ Time Frame: Visit (12 weeks) ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having participated in a preceding ABT-874 clinical trial for ABT-874
  • Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion Criteria:

  • Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 152 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Martin Kaul, MD AbbVie
  More Information

Responsible Party: 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

Keywords provided by AbbVie:
Open label

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 17, 2017