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Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710580
First Posted: July 4, 2008
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Paragon Biomedical
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

Condition Intervention Phase
Moderate to Severe Plaque Psoriasis Biological: ABT-874 Biological: etanercept Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ]
  • Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ]

Enrollment: 350
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: ABT-874
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
Active Comparator: B Biological: etanercept
SQ injection 50 mg BIW
Placebo Comparator: C Drug: placebo
SQ placebo injections for ABT-874 and etanercept

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of Psoriasis for 6 MO
  • BSA 10%
  • PASI 12 or above
  • PGA 3 or above

Exclusion Criteria:

  • Previous exposure to either etanercept or ABT-874
  Contacts and Locations
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): NCT00710580


  Show 42 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Paragon Biomedical
Investigators
Study Director: Martin Kaul, MD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00710580     History of Changes
Other Study ID Numbers: M10-315
First Submitted: July 2, 2008
First Posted: July 4, 2008
Last Update Posted: January 18, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors