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Open Label Continuation Study in Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT00626002
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease Intervention/treatment Phase
Moderate to Severe Plaque Psoriasis Drug: ABT-874 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2301 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 1 Drug: ABT-874
100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks
Other Name: briakinumab




Primary Outcome Measures :
  1. Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit. [ Time Frame: Visit (12 weeks) ]
  2. 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) ]
  3. 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) ]
  4. AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study [ Time Frame: Visit (12 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626002


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

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00626002     History of Changes
Other Study ID Numbers: M10-016
2007-005955-40 ( EudraCT Number )
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Open label

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