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A Study of the Safety and Effectiveness of Infliximab 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: NCT00106847
Recruitment Status : Completed
First Posted : April 1, 2005
Last Update Posted : May 17, 2011
Information provided by:
Centocor, Inc.

Brief Summary:
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Condition or disease Intervention/treatment Phase
Psoriasis Parapsoriasis Drug: Infliximab Phase 3

Detailed Description:

This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.

Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis
Study Start Date : January 2003
Actual Study Completion Date : July 2005

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 who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.

Secondary Outcome Measures :
  1. Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physician's Global Assessment score of clear or excellent at week 10.

Information from the National Library of Medicine

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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:

  • Patients with diagnosis of plaque-type psoriasis for at least 6 months
  • Patients with plaque-type psoriasis covering at least 10% of the body

Exclusion Criteria:

  • Patients with nonplaque forms of psoriasis
  • Patients who have current drug-induced psoriasis
  • Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
  • Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor

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): NCT00106847

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: NCT00106847     History of Changes
Other Study ID Numbers: CR005290
First Posted: April 1, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010
Keywords provided by Centocor, Inc.:
plaque-type psoriasis
drug safety
drug efficacy
maintenance therapy
induction therapy
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents