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Immunoadsorption in Patients With Severe Systemic Sclerosis

Primary Purpose

Systemic Scleroderma

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

TheraSorb Ig

About this trial

This is an interventional treatment trial for Systemic Scleroderma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

systemic sclerosis according to the ACE-criteria
severe pulmonary manifestation with reduced DLCO
signed informed consent

Exclusion Criteria:

inadequate peripheral venous access
participation in another clinical trial
heart failure
pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit

Sites / Locations

Universitätsklinikum Dresden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TheraSorb Ig

Arm Description

Outcomes

Primary Outcome Measures

survival under immunoadsorption

Secondary Outcome Measures

survival under immunoadsorption

Number of Serious Adverse Events

change in "modified Rodnan Skin Score"

change in Diffusing Capacity of the Lung for Carbon Monoxide

change in Scleroderma Health Assenssment Questionnaire

change of pulmonary arterial pressure

reoccurrence of finger ulcers

healing of finger ulcers

Full Information

NCT ID

NCT01410903

First Posted

August 4, 2011

Last Updated

August 18, 2015

Sponsor

GWT-TUD GmbH

Collaborators

Miltenyi Biomedicine GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01410903

Brief Title

Immunoadsorption in Patients With Severe Systemic Sclerosis

Official Title

Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

inadequately recruitment rate, funding is not secured

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GWT-TUD GmbH

Collaborators

Miltenyi Biomedicine GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.

6. Conditions and Keywords

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

Systemic Scleroderma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TheraSorb Ig

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

TheraSorb Ig

Other Intervention Name(s)

Ig-TheraSorb, code 330-000-452

Intervention Description

1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months

Primary Outcome Measure Information:

Title

survival under immunoadsorption

Time Frame

6 months

Secondary Outcome Measure Information:

Title

survival under immunoadsorption

Time Frame

12 months

Title

Number of Serious Adverse Events

Time Frame

12 months

Title

change in "modified Rodnan Skin Score"

Time Frame

12 months

Title

change in Diffusing Capacity of the Lung for Carbon Monoxide

Time Frame

12 months

Title

change in Scleroderma Health Assenssment Questionnaire

Time Frame

12 months

Title

change of pulmonary arterial pressure

Time Frame

12 months

Title

reoccurrence of finger ulcers

Time Frame

12 months

Title

healing of finger ulcers

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: systemic sclerosis according to the ACE-criteria severe pulmonary manifestation with reduced DLCO signed informed consent Exclusion Criteria: inadequate peripheral venous access participation in another clinical trial heart failure pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Aringer, Prof.

Organizational Affiliation

Universitätsklinikum Dresden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinikum Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Immunoadsorption in Patients With Severe Systemic Sclerosis

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