Evaluating the safety and effectiveness of GLOBAFFIN® for autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to document the safety and effectiveness profile of the immunoadsorber GLOBAFFIN® in clinical practice for patients with autoimmune diseases. The primary objective is to estimate the mean relative reduction in total IgG levels from pre- to post-treatment after each session. Patients aged 18 and older who meet specific inclusion criteria will receive treatment with GLOBAFFIN® according to its intended use. The study will follow a structured approach to ensure compliance and accurate documentation of results.

Why it matters

Who can join: the full rules

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

Where it's running

• Städtisches Klinikum Braunschweig
  Braunschweig, Niedersachsen, Germany Recruiting
• Diakonissenkrankenhaus Flensburg
  Flensburg, Germany Recruiting
• University of Ulm - Department of Neurology
  Ulm, Germany Recruiting

Study contacts

• Principal investigator: Jan T. Kielstein, Prof. Dr. — Academic Teaching Hospital Braunschweig
• Study coordinator: Manuela Stauss-Grabo, Dr.
• Email: Manuela.Stauss-Grabo1@FreseniusMedicalCare.com
• Phone: +49 6172 609 5248

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.