A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis

NCT00106834 | Completed Phase 3

• 1 other identifier: CR003130
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if infliximab (anti-TNF) is effective in the treatment of plaque psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; Infliximab; Remicade

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a = 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 10

Secondary Outcomes (1)

• The patients with = 75% improvement in PASI score from baseline to week 24 ,Change in Dermatology Life Quality Index from baseline to week 10 and week 24 , patients achieving a Physician Global Assessment score of cleared (0) or minimal(1) at week 10

Interventions

Infliximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have had a diagnosis of plaque-type psoriasis for at least 6 months
• Patients who have plaque-type psoriasis covering at least 10% of the body

You may not qualify if:

• Patients must not have nonplaque forms of psoriasis
• Patients must not have current drug-induced psoriasis
• Patients must not be pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
• Patients must not have had any previous treatment with infliximab or any therapeutic agent targeted at reducing TNF

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (4)

• Rich P, Griffiths CE, Reich K, Nestle FO, Scher RK, Li S, Xu S, Hsu MC, Guzzo C. Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year. J Am Acad Dermatol. 2008 Feb;58(2):224-31. doi: 10.1016/j.jaad.2007.07.042. Epub 2007 Dec 20.

  PMID: 18083272 BACKGROUND

• Reich K, Nestle FO, Wu Y, Bala M, Eisenberg D, Guzzo C, Li S, Dooley LT, Griffiths CE. Infliximab treatment improves productivity among patients with moderate-to-severe psoriasis. Eur J Dermatol. 2007 Sep-Oct;17(5):381-6. doi: 10.1684/ejd.2007.0234. Epub 2007 Aug 2.

  PMID: 17673380 RESULT

• Reich K, Nestle FO, Papp K, Ortonne JP, Wu Y, Bala M, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE. Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: a randomized controlled trial. Br J Dermatol. 2006 Jun;154(6):1161-8. doi: 10.1111/j.1365-2133.2006.07237.x.

  PMID: 16704649 RESULT

• Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE; EXPRESS study investigators. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005 Oct 15-21;366(9494):1367-74. doi: 10.1016/S0140-6736(05)67566-6.

  PMID: 16226614 RESULT

Related Links

• A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction and Maintenance Therapy in Patients with Moderate to Severe Plaque Psoriasis

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2005
• First Posted: April 1, 2005
• Study Completion: October 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-03