Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00581555

Purpose

The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.

Condition	Intervention	Phase
Psoriasis	Drug: Etanercept Other: Placebo	Phase IV

MedlinePlus related topics: Psoriasis

Drug Information available for: Cyclosporine Cyclosporin Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy

Further study details as provided by Wyeth:

Primary Outcome Measures:

Evaluation of change in PASI score from randomization to week 24 [ Time Frame: 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PASI Area under the Curve between randomization and week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in PGA score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
% Relapse and time to relapse [ Time Frame: 24 ] [ Designated as safety issue: No ]
% Improvement in PASI score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in DLQI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Rebound effects (worsening of psoriasis) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	144
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Treatment with Etanercept after initial course of ciclosporin	Drug: Etanercept Etanercept 50 mg QW initiated during taper of ciclosporin
2: Placebo Comparator Randomized to Placebo during taper of ciclosporin	Other: Placebo Randomized to placebo during taper of ciclosporine

Detailed Description:

The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between age 18 and 70 years
Active and stable plaque psoriasis

Exclusion Criteria:

Evidence of skin conditions other than psoriasis
Psoralen plus PUVA, ciclosportin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or DMARD with 28 days of screening
UVB therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Corticosteroid dose of prednisone >10 mg/day
Serious infection
Receipt of any live vaccine
Abnormal hematology or chemistry
BMI > 38
Pregnancy or Breast-feeding
Significant concurrent medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581555

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A6-410
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00581555 History of Changes
Health Authority:	Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Bioethics Committee; Italy: National Institute of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency

Keywords provided by Wyeth:

Psoriasis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Cyclosporine
Skin Diseases
Immunologic Factors
Clotrimazole
Miconazole
Tioconazole
TNFR-Fc fusion protein
Cyclosporins

Immunosuppressive Agents
Analgesics, Non-Narcotic
Psoriasis
Antifungal Agents
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Cyclosporine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
TNFR-Fc fusion protein
Cyclosporins
Psoriasis
Sensory System Agents
Antifungal Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Dermatologic Agents
Skin Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Skin Diseases, Papulosquamous
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009