Systemic Scleroderma
Conditions
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.
Interventions
DEVICETheraSorb 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
Sponsors
Miltenyi Biomedicine GmbH
GWT-TUD GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival under immunoadsorption | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| survival under immunoadsorption | 12 months |
| change of pulmonary arterial pressure | 12 months |
| reoccurrence of finger ulcers | 12 months |
| healing of finger ulcers | 12 months |
| change in Scleroderma Health Assenssment Questionnaire | 12 months |
Countries
Germany
Outcome results
None listed