Immunoadsorption in Patients With Severe Systemic Sclerosis

GWT-TUD GmbH1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Scleroderma

Interventions

TheraSorb IgDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Dresden

Dresden, Germany

Outcomes

Primary Outcomes

survival under immunoadsorption

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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