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A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis

This study has been completed.
Information provided by:
Centocor, Inc. Identifier:
First received: March 31, 2005
Last updated: May 16, 2011
Last verified: April 2010
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 Intervention Phase
Psoriasis Parapsoriasis Drug: Infliximab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 683
Study Start Date: January 2003
Study Completion Date: July 2005
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00106847

Sponsors and Collaborators
Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications: Identifier: NCT00106847     History of Changes
Other Study ID Numbers: CR005290
Study First Received: March 31, 2005
Last Updated: May 16, 2011

Keywords provided by Centocor, Inc.:
plaque-type psoriasis
drug safety
drug efficacy
maintenance therapy
induction therapy

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on August 22, 2017