A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230529
• Other study ID #: CR003124
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2005
• Last updated: June 8, 2011
• Est. completion date: January 2003

Study information

• Verified date: August 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.

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.

Other known NCT identifiers

• NCT01128491

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• infliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (2)

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 — View 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):53 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
Secondary	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

External Links

•   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.