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Granulocytapheresis in Psoriasis (GRIP)

Primary Purpose

Psoriasis

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

Treatment with a sham device, EXcorLab box 1.2

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring granulocytapheresis, psoriasis, PASI, apheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Written informed consent that can be withdrawn at any time or for any reason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

Sites / Locations

University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology
University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Granulocytapheresis treatment

Sham device treatment

Outcomes

Primary Outcome Measures

>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis

Secondary Outcome Measures

Patients Achieving an Improvement of PASI by >/= 50%

Full Information

NCT ID

NCT00714272

First Posted

June 4, 2008

Last Updated

July 30, 2020

Sponsor

EXcorLab GmbH

Collaborators

Membrana GmbH, Nikkiso Co. Ltd, Nikkiso Medical GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00714272

Brief Title

Granulocytapheresis in Psoriasis

Acronym

GRIP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Primary outcome not achieved.

Study Start Date

February 18, 2008 (Actual)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EXcorLab GmbH

Collaborators

Membrana GmbH, Nikkiso Co. Ltd, Nikkiso Medical GmbH

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

granulocytapheresis, psoriasis, PASI, apheresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Granulocytapheresis treatment

Arm Title

Arm Type

Placebo Comparator

Arm Description

Sham device treatment

Intervention Type

Device

Intervention Name(s)

Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Treatment with a sham device, EXcorLab box 1.2

Intervention Description

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

Primary Outcome Measure Information:

Title

>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis

Time Frame

At the end of the granulocytapheresis treatment period

Secondary Outcome Measure Information:

Title

Patients Achieving an Improvement of PASI by >/= 50%

Time Frame

From baseline to weeks 2, 6, 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: