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Clinical Trials/NCT01410903
NCT01410903
Terminated
Not Applicable

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

GWT-TUD GmbH1 site in 1 country1 target enrollmentApril 2011
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ConditionsSystemic Scleroderma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Scleroderma
Sponsor
GWT-TUD GmbH
Enrollment
1
Locations
1
Primary Endpoint
survival under immunoadsorption
Status
Terminated
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
August 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

survival under immunoadsorption

Time Frame: 6 months

Secondary Outcomes

  • survival under immunoadsorption(12 months)
  • Number of Serious Adverse Events(12 months)
  • change in "modified Rodnan Skin Score"(12 months)
  • change in Diffusing Capacity of the Lung for Carbon Monoxide(12 months)
  • change in Scleroderma Health Assenssment Questionnaire(12 months)
  • change of pulmonary arterial pressure(12 months)
  • reoccurrence of finger ulcers(12 months)
  • healing of finger ulcers(12 months)

Study Sites (1)

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