Immunoadsorption in Patients With Severe Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410903
Recruitment Status : Terminated (inadequately recruitment rate, funding is not secured)
First Posted : August 5, 2011
Last Update Posted : August 19, 2015
Miltenyi Biotec GmbH
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Systemic Scleroderma Device: TheraSorb Ig Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TheraSorb Ig Device: TheraSorb Ig
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
Other Names:
  • Ig-TheraSorb
  • code 330-000-452

Primary Outcome Measures :
  1. survival under immunoadsorption [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. survival under immunoadsorption [ Time Frame: 12 months ]
  2. Number of Serious Adverse Events [ Time Frame: 12 months ]
  3. change in "modified Rodnan Skin Score" [ Time Frame: 12 months ]
  4. change in Diffusing Capacity of the Lung for Carbon Monoxide [ Time Frame: 12 months ]
  5. change in Scleroderma Health Assenssment Questionnaire [ Time Frame: 12 months ]
  6. change of pulmonary arterial pressure [ Time Frame: 12 months ]
  7. reoccurrence of finger ulcers [ Time Frame: 12 months ]
  8. healing of finger ulcers [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410903

Universitätsklinikum Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Miltenyi Biotec GmbH
Principal Investigator: Martin Aringer, Prof. Universitätsklinikum Dresden

Responsible Party: GWT-TUD GmbH Identifier: NCT01410903     History of Changes
Other Study ID Numbers: IAS - SSc 2010
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases