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TRUST Study: Raptiva ® in Hand & Foot Psoriasis

NCT00739882 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-02-27

Study results available
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Summary

To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).

Conditions

  • Chronic Plaque Psoriasis

Interventions

DRUG

Efalizumab - anti CD11a recombinant human monoclonal antibody

Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.

DRUG

Placebo

Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Nicole Selenko-Gebauer, MD · Merck Serono S.A., Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Austria

Study Locations

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Entities

Drugs

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 NCT00739882 on ClinicalTrials.gov