Immune System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Autoimmune Diseases

Neoplasm Metastasis

Immunologic Deficiency Syndromes

Primary Immunodeficiency Diseases

Syndrome

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Genetic Diseases, Inborn

Quality of Life

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Immunologic Factors

Any marketed SC or IV IgG can be documented

Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented.

Immunoglobulin G (IgG)

Wilhelm Kirch, MD, PhD

David Pittrow, MD, PhD

Michael Borte, MD, PhD

Ulrich Baumann, MD, PhD

Manfred Hensel, MD, PhD

Dörte Huscher

Marcel Reiser, MD, PhD

Martin Stangel, MD, PhD

Ralph Gold, MD, PhD

Claudia Sommer, MD, PhD

This non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine clinical conditions in Germany.

Long-term outcome data are collected on patient characteristics in the various indications, drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns), effectiveness (i.e. number of infections), tolerability, health related quality of life, and economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to estimate direct costs.

In view of the broad range of indications in immunodeficiency and immunomodulation, it is of interest to document the use of IgG under the conditions of everyday practice and to analyze the endpoints (outcomes). A prospective cohort study such as this is an important evidence source for such rare diseases as those mentioned above. The aim of this outcome study is to fill the gap of the lack of long-term data in these rare diseases treated with IgG.

Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study

An Open, Uncontrolled, Non-interventional Observational Cohort Outcome Study of Immunoglobulins in 3 Indications: Primary and Secondary Immunodeficiencies and Neurological Auto-immune Diseases

Dosage of immunoglobulins (IgG); frequency of IgG administrations; days of treatment with IgG; duration of infusion of IgG.

For immunodeficiencies (primary PID and secondary SID):

frequency of infections; degree of severity of infections (SBIs); duration of antibiotic treatment; necessity of antibiotic treatment.

Grip strength (dynamometer) Electrophysiology (EMG, ENG); Inflammatory Neuropathy Cause and Treatment (INCAT) disability score; EDSS, annual relapse rate; Myasthenia Score.

Number of sick-leave days Number of medical visits Days of hospitalisation due to infections or due to disability or loss of function Degree of disability

GWT-TUD GmbH

Technische Universität Dresden

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study	NCT01287689	Primary Immunod... Secondary Immun... Neurological Au...	Immunoglobulin ...	-	Technische Universität Dresden
Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study	NCT01287689	Primary Immunod... Secondary Immun... Neurological Au...	Immunoglobulin ...	-	Technische Universität Dresden

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