This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Immunoadsorption in Patients With Severe Systemic Sclerosis

This study has been terminated.
(inadequately recruitment rate, funding is not secured)
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
GWT-TUD GmbH Identifier:
First received: August 4, 2011
Last updated: August 18, 2015
Last verified: August 2015
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 Intervention
Systemic Scleroderma Device: TheraSorb Ig

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GWT-TUD GmbH:

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

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

Enrollment: 1
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01410903

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

Responsible Party: GWT-TUD GmbH Identifier: NCT01410903     History of Changes
Other Study ID Numbers: IAS - SSc 2010
Study First Received: August 4, 2011
Last Updated: August 18, 2015

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases processed this record on August 18, 2017