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
1 other identifier
interventional
683
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2005
CompletedFirst Posted
Study publicly available on registry
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedMay 17, 2011
April 1, 2010
March 31, 2005
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of plaque-type psoriasis for at least 6 months
- Patients with plaque-type psoriasis covering at least 10% of the body
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Related Publications (1)
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. doi: 10.1016/j.jaad.2006.07.017. Epub 2006 Sep 6.
PMID: 17097378RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2005
First Posted
April 1, 2005
Study Start
January 1, 2003
Study Completion
July 1, 2005
Last Updated
May 17, 2011
Record last verified: 2010-04