A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis - Full Text View

Sponsor:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00230529

Purpose

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.

Condition	Intervention	Phase
Psoriasis	Drug: infliximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE®) Induction Therapy in Patients With Plaque-Type Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10

Secondary Outcome Measures:

The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week26 by status of antibodies to infliximab at week 26

Estimated Enrollment:	200
Study Completion Date:	January 2003

Detailed Description:

The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement.

The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.

Eligibility

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

Criteria

Inclusion Criteria:

Must be 18 years of age or older at time of enrollment
May be male or female
Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
Have plaque-type psoriasis covering at least 10% of total BSA at baseline
Have previously received PUVA and/or other systemic treatment for psoriasis

Exclusion Criteria:

Have non-plaque forms of psoriasis
Have a history of drug-induced psoriasis
Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
Have had any previous treatment with infliximab or any therapeutic agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230529

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE®) Induction Therapy in Patients with Plaque-type Psoriasis. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Feldman SR, Gordon KB, Bala M, Evans R, Li S, Dooley LT, Guzzo C, Patel K, Menter A, Gottlieb AB. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005 May;152(5):954-60.

Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42.

Study ID Numbers:	CR003124
Study First Received:	September 29, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00230529 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Plaque-type Psoriasis
Remicade
infliximab
biologics

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Skin Diseases
Infliximab
Psoriasis
Therapeutic Uses

Gastrointestinal Agents
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010