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

This study is currently recruiting participants.

Verified by Abbott, December 2008

Sponsors and Collaborators:	Abbott Paragon Biomedical
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00691964

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 III

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	350
Study Start Date:	June 2008
Estimated Primary Completion Date:	March 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: NCT00691964

Contacts

Contact: Nicky Mayber, RN	847-936-6362
Contact: Beverly Paperiello, MS	874-937-3872

Show 41 Study Locations

Sponsors and Collaborators

Abbott

Paragon Biomedical

More Information

Responsible Party:	Abbott ( Nicky Mayber )
Study ID Numbers:	M10-114
Study First Received:	June 4, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00691964
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
TNFR-Fc fusion protein
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

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

ClinicalTrials.gov processed this record on January 15, 2009