Granulocytapheresis in Psoriasis

Psoriasis Clinical Trial

— GRIP  

Official title:

Therapeutic Effect of Granulocytapheresis in Psoriasis (GRIP-study)Using a Novel Cellulose-based Adsorber Device

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00714272
• Other study ID #: KSGA0801
• Secondary ID: F002MN0107_1
• Status: Terminated
• Phase: N/A
• Start date: February 18, 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2020
• Source: EXcorLab GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe plaque psoriasis with a PASI >/=10

• Age >/= 18 years

• Negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women

• Written informed consent that can be withdrawn at any time or for any reason

• Discontinuation of any systemic psoriasis treatment. Washout period of at least two weeks for prior systemic medications

• Only emollients for topical treatment

• No vaccinations for at least 14 days prior to first treatment

Exclusion Criteria:

• Other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.)

• History of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); HIV positivity

• Pregnancy

• Clinically relevant thrombocytopenia or bleeding disorders

• WBC <4.000 or >12.000/µl

• Malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin)

• Severe cardiac disorders, stroke, pulmonary disease within the last year

• Any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1
6 treatments. One per week during the first six consecutive weeks.
• Treatment with a sham device, EXcorLab box 1.2
6 sham treatments. One treatment per week during the first six consecutive weeks.

Locations

Country	Name	City	State
Germany	University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology	Göttingen	Lower Saxony
Germany	University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology	Wuerzburg	Bavaria

Sponsors (4)

Lead Sponsor	Collaborator
EXcorLab GmbH	Membrana GmbH, Nikkiso Co. Ltd, Nikkiso Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis		At the end of the granulocytapheresis treatment period
Secondary	Patients Achieving an Improvement of PASI by >/= 50%		From baseline to weeks 2, 6, 12 and 24