Text Size

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:
NCT00691964
First received: June 4, 2008
Last updated: January 11, 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
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, Multi-Center, 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: 347
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 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: NCT00691964

  Show 35 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: NCT00691964     History of Changes
Other Study ID Numbers: M10-114
Study First Received: June 4, 2008
Last Updated: January 11, 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 21, 2013