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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00106847
First received: March 31, 2005
Last updated: May 16, 2011
Last verified: April 2010
History of Changes

March 31, 2005
May 16, 2011
January 2003
 
Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.
The proportion of subjects who achieve greater than or equal to 75% improvement in PASI from baseline at week 10
Complete list of historical versions of study NCT00106847 on ClinicalTrials.gov Archive Site
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.
  • The average percent improvement from baseline in PASI response between week 16 and week 30
  • The change in Dermatology Life Quality Index from baseline at week 10
  • The proportion of subjects with a Physician’s Global Assessment (PGA) score of clear (1) orexcellent (2) at week 10
 
 
 
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Psoriasis
  • Parapsoriasis
Drug: Infliximab
 
Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, Li S, Dooley LT, Arnold C, Gottlieb AB. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007 Jan;56(1):31.e1-15. Epub 2006 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
683
July 2005
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00106847
CR005290
 
 
Centocor, Inc.
 
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP