Back to resultsA Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque-type Psoriasis, infliximab, Remicade, biologics
Eligibility Criteria
Inclusion Criteria: Must be 18 years of age or older at time of enrollment may be male or female Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening Have plaque-type psoriasis covering at least 10% of total BSA at baseline Have previously received PUVA and/or other systemic treatment for psoriasis Exclusion Criteria: Have non-plaque forms of psoriasis Have a history of drug-induced psoriasis Are pregnant, nursing, or planning pregnancy within 12 months of enrollment Have had any previous treatment with infliximab or any therapeutic agent
Sites / Locations
Outcomes
Primary Outcome Measures
Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
Secondary Outcome Measures
The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00230529
Brief Title
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
Official Title
A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients With Plaque-type Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
Detailed Description
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque-type Psoriasis, infliximab, Remicade, biologics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
infliximab
Primary Outcome Measure Information:
Title
Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
Secondary Outcome Measure Information:
Title
The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be 18 years of age or older at time of enrollment
may be male or female
Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
Have plaque-type psoriasis covering at least 10% of total BSA at baseline
Have previously received PUVA and/or other systemic treatment for psoriasis
Exclusion Criteria:
Have non-plaque forms of psoriasis
Have a history of drug-induced psoriasis
Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
Have had any previous treatment with infliximab or any therapeutic agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15389187
Citation
Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021.
Results Reference
result
PubMed Identifier
15888152
Citation
Feldman SR, Gordon KB, Bala M, Evans R, Li S, Dooley LT, Guzzo C, Patel K, Menter A, Gottlieb AB. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005 May;152(5):954-60. doi: 10.1111/j.1365-2133.2005.06510.x.
Results Reference
result
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=142&filename=CR003124_CSR.pdf
Description
A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients with Plaque-type Psoriasis.
Learn more about this trial
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
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