PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept - Full Text View

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00527072

Purpose

The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms.

Condition	Intervention	Phase
Psoriasis	Biological: infliximab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Study to Assess the Efficacy and Safety of Infliximab (REMICADE®) Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to Etanercept (ENBREL®)

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Infliximab Etanercept

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The primary analysis for the study is the proportion of patients achieving a Physician's Global Assessment (PGA) of minimal (1) or clear (0) at Week 10. [ Time Frame: Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Some major secondary analyses include the proportion of patients: with PGA of 1 or 0 at Weeks 1, 2, 4, 6, 14, 22, and 26; achieving PASI 50, PASI 75, PASI 90, and PASI 100 at Weeks 10 and 26; achieving a DLQI score of 0 or 1 at Weeks 10 and 26. [ Time Frame: Through Week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Biological: infliximab Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

Detailed Description:

The most common form of psoriasis is plaque-type psoriasis, which is characterized by recurrent flaring of thickened, red, scaly patches of skin.

Although psoriasis is usually not life threatening, these physical discomforts combined with the potential psychological effects of the disease may interfere with everyday activities and negatively impact an individual's quality of life. Infliximab is an antibody made in a laboratory. Antibodies are proteins that fight other substances in the body that may cause infections or diseases. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is related to the itchy patches of skin (or plaques) of psoriasis. Infliximab stops the TNF from working. Other studies have shown that stopping the TNF may reduce the plaques. To address the unmet medical need for effective chronic therapies, TNFalpha blockers have recently been used to treat patients with moderate to severe plaque psoriasis. Etanercept also works by stopping the TNF, but in a different way than infliximab. This multi-center, open-label study is designed to test whether or not patients with plaque psoriasis who have not responded well to etanercept treatment may benefit from treatment with infliximab. Key effectiveness measurements will include the time to onset of symptom improvement and health-related quality of life. Safety will be assessed throughout the study.

Two weeks after their last dose of etanercept, all eligible patients will receive open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have plaque psoriasis despite at least 4 months of treatment with etanercept per current product labeling
Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at screening
If receiving methotrexate at screening, must have received methotrexate for at least 3 months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening
If receiving cyclosporine at screening, must have received cyclosporine at a stable dose of <= 5 mg/kg daily for at least 4 weeks prior to screening

Exclusion Criteria:

Have already received infliximab or adalimumab
Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product
Have a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
Have a concomitant diagnosis or any history of Congestive Heart Failure
Are pregnant, nursing, or planning pregnancy
Have used systemic corticosteroids within the 4 weeks prior to screening
Have used topical corticosteroids or have initiated treatment with other topical therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI) evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2 weeks prior to screening
Have used new systemic agents/treatments, other than methotrexate, that can affect psoriasis including, but not limited to, immunosuppressants and/or psoralen plus ultraviolet A light (PUVA) within the 4 weeks prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527072

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Centocor Inc. ( Sr. Director, Clinical Research - Medical Affairs )
Study ID Numbers:	CR014500, C0168Z04
Study First Received:	September 6, 2007
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00527072 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

C0168Z04
psoriasis
psunrise
plaque psoriasis

enbrel
remicade
etanercept
infliximab

Study placed in the following topic categories:

Anti-Inflammatory Agents
Skin Diseases
Immunologic Factors
Infliximab
TNFR-Fc fusion protein
Immunosuppressive Agents
Psoriasis

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

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on July 02, 2009