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.

First Received: July 2, 2008 Last Updated: May 7, 2009 History of Changes

Sponsors and Collaborators:	Abbott Paragon Biomedical
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00710580

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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 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 ] [ 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
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: ABT-874 SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
B: Active Comparator	Biological: etanercept SQ injection 50 mg BIW
C: Placebo Comparator	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 41 Study Locations

Sponsors and Collaborators

Abbott

Paragon Biomedical

More Information

No publications provided

Responsible Party:	Abbott ( Nicky Mayber )
Study ID Numbers:	M10-315
Study First Received:	July 2, 2008
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00710580 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Analgesics, Non-Narcotic
Psoriasis
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 11, 2009