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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230529
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : June 9, 2011
Information provided by:
Centocor, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: infliximab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Infliximab

Primary Outcome Measures :
  1. Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10

Secondary Outcome Measures :
  1. 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 week 26 by antibodies to infliximab status at week 26

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230529

Sponsors and Collaborators
Centocor, Inc.
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00230529    
Obsolete Identifiers: NCT01128491
Other Study ID Numbers: CR003124
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: August 2010
Keywords provided by Centocor, Inc.:
Plaque-type Psoriasis
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents