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) ] [ 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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 April 16, 2014