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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230529

Enrollment

249

Registered

2005-10-03

Start date

Unknown

Completion date

2003-01-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Plaque-type Psoriasis, infliximab, Remicade, biologics

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.

Interventions

DRUGinfliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026