Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine

Study Overview
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Brief Summary
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Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

Detailed Description
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The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.

Official Title
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Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Device: Immunoadsorber GLOBAFFIN®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years Informed consent signed and dated by study patient and investigator/authorised physician Ability to understand the nature and requirements of the study Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use. Exclusion Criteria: General: Any condition which could interfere with the patient's ability to comply with the study In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required) Participation in an interventional clinical study during the preceding 30 days. Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days. Any deviation from the intended use Study-specific: Any contraindication listed in the valid instruction for use: Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution Previously demonstrated hypersensitivity associated with therapeutic apheresis No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard Severe cardiovascular disease, so that extracorporeal treatment is not possible Acute, systemic infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-centre, open-label, non-comparative, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with the IgG immunoadsorber GLOBAFFIN®<br>Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. | Device: Immunoadsorber GLOBAFFIN®<br>* Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN® |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean relative reduction in disease-specific IgG, total IgM and total IgA |  | 5 years | 
| Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic apheresis, Immune apheresis