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
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

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
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 22, 2014