Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00936065

Purpose

To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.

Condition	Intervention	Phase
Moderate to Severe Psoriasis	Drug: Etanercept Drug: Etanercept + Acitretin Drug: Acitretin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Acitretin Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Proportion of subjects achieving a 75% improvement from baseline in PASI score at week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving a 50% improvement from baseline in PASI score at each visit through week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects achieving a status on the Physician Global Assessment of psoriasis (PGA) of clear (0), clear/almost clear (0, 1), or clear/almost clear/mild (0, 1, 2) at each visit through week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to PASI 50, PASI 75 and PGA of clear/almost clear/mild and PGA of clear/almost clear over 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline at each visit in the PGA through 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline at each visit in the PASI through 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline at each visit in the % BSA involvement of psoriasis through 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline at each visit in the subject assessments (general health, psoriasis activity, and itching) through 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline at each visit in the Psoriasis Subject Satisfaction Questionnaire (PSSQ) through 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	July 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A	Drug: Etanercept Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks Other Name: Etanercept 50mg followed by 25mg
Experimental: Group B	Drug: Etanercept + Acitretin Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks Other Name: Etancercept 25mg and Acitretin 10mg
Active Comparator: Group C	Drug: Acitretin Acitretin at a dose of 10mg BID for 24 weeks Other Name: Acitretin 10mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
Negative urine pregnancy test before the first dose of study drug in all female patients

Exclusion Criteria:

Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936065

Locations

Korea, Republic of
Pfizer Investigational Site
Daejeon, Korea, Korea, Republic of, 301 721
Pfizer Investigational Site
Gyeonggido, Korea, Korea, Republic of, 420 717
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 152 703
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 137 701
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 130 702
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 110 744
Pfizer Investigational Site
S0, Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 431-070
Pfizer Investigational Site
Seoul, Korea, Republic of, 135 710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138 736

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00936065 History of Changes
Other Study ID Numbers:	0881A6-4625, B1801065
Study First Received:	July 7, 2009
Last Updated:	May 13, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Etanercept
Acitretin
Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acitretin
TNFR-Fc fusion protein
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012