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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:
Collaborator:
Paragon Biomedical
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00710580
First received: July 2, 2008
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by AbbVie:

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 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710580

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

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00710580     History of Changes
Other Study ID Numbers: M10-315
Study First Received: July 2, 2008
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013