Clinical trial NCT00714272: Granulocytapheresis in Psoriasis
Official title: Therapeutic Effect of Granulocytapheresis in Psoriasis (GRIP-study)Using a Novel Cellulose-based Adsorber Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psoriasis
Keywords: granulocytapheresis, psoriasis, PASI, apheresis
Lead sponsor: EXcorLab GmbH
Sponsor class: OTHER
Collaborators: name: Membrana GmbH
name: Nikkiso Co. Ltd
name: Nikkiso Medical GmbH
First posted: 2008-07-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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* Written informed consent that can be withdrawn at any time or for any reason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

Primary outcomes:
measure: >/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis
timeFrame: At the end of the granulocytapheresis treatment period
Secondary outcomes:
measure: Patients Achieving an Improvement of PASI by >/= 50%
timeFrame: From baseline to weeks 2, 6, 12 and 24
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology
state: Bavaria
city: Göttingen
country: Germany
facility: University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology
state: Lower Saxony
Study officials:
affiliation: University of Goettingen, Department of Dermatology and Venerology
name: Michael P Schoen, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Wuerzburg, Department of Medicine
name: Christoph Wanner, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: University of Wuerzburg, Department of Dermatology
name: Eva B Broecker, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: University of Goettingen, Department of Nephrology and Rheumatology
name: Gerhard A Mueller, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: University Hospital Wuerzburg, Department of Medicine
name: Detlef Krieter, Dr.med.
role: STUDY_DIRECTOR
References: