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Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(COMPLETED)

NCT00254982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 593

Last updated 2015-10-12

Study results available
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Summary

This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I ("high need") or GROUP II ("low-need") by the investigator according to their previous psoriasis treatment.

Conditions

Interventions

BIOLOGICAL

Infliximab

Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.

Sponsors & Collaborators

  • Essex Pharma GmbH

    collaborator INDUSTRY

  • Centocor, Inc.

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-09-30
Completion
2006-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254982 on ClinicalTrials.gov