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Granulocytapheresis in Psoriasis

NCT00714272 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-08-14

Study results available
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Summary

In a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). The effects on clinical symptoms and on some inflammatory parameters of patients with moderate to severe plaque psoriasis will be evaluated over a 24-week period.

The primary end-point is a ≥75 percent improvement in PASI (Psoriasis Area and Severity Index).

The study purpose is to demonstrate a beneficial therapeutic effect of granulocytapheresis using the novel cellulose-based adsorber device in moderate to severe plaque psoriasis.

Conditions

Interventions

DEVICE

Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

6 treatments. One per week during the first six consecutive weeks.

DEVICE

Treatment with a sham device, EXcorLab box 1.2

6 sham treatments. One treatment per week during the first six consecutive weeks.

Sponsors & Collaborators

  • Membrana GmbH

    collaborator INDUSTRY

  • Nikkiso Co. Ltd

    collaborator INDUSTRY

  • Nikkiso Medical GmbH

    collaborator INDUSTRY

  • EXcorLab GmbH

    lead OTHER

Principal Investigators

  • Michael P Schoen, Prof.Dr.med. · University of Goettingen, Department of Dermatology and Venerology

  • Christoph Wanner, Prof.Dr.med. · University Hospital Wuerzburg, Department of Medicine

  • Eva B Broecker, Prof.Dr.med. · University of Wuerzburg, Department of Dermatology

  • Gerhard A Mueller, Prof.Dr.med. · University of Goettingen, Department of Nephrology and Rheumatology

  • Detlef Krieter, Dr.med. · University Hospital Wuerzburg, Department of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-18
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT00714272 on ClinicalTrials.gov