Immunoadsorption in Patients With Severe Systemic Sclerosis

Systemic Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01410903
• Other study ID #: IAS - SSc 2010
• Status: Terminated
• Phase: N/A
• First received: August 4, 2011
• Last updated: August 18, 2015
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Scleroderma

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Dresden	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Miltenyi Biotec GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival under immunoadsorption		6 months	No
Secondary	survival under immunoadsorption		12 months	Yes
Secondary	Number of Serious Adverse Events		12 months	Yes
Secondary	change in "modified Rodnan Skin Score"		12 months	No
Secondary	change in Diffusing Capacity of the Lung for Carbon Monoxide		12 months	No
Secondary	change in Scleroderma Health Assenssment Questionnaire		12 months	No
Secondary	change of pulmonary arterial pressure		12 months	No
Secondary	reoccurrence of finger ulcers		12 months	No
Secondary	healing of finger ulcers		12 months	No