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

Summary

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.

Conditions

• Primary Immunodeficiency (PID)
• Secondary Immunodeficiency (SID)
• Neurological Autoimmune Disease

Interventions

OTHER

Immunoglobulin G (IgG)

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

Sponsors & Collaborators

• GWT-TUD GmbH

  collaborator OTHER

• Technische Universität Dresden

  lead OTHER

Principal Investigators

• Wilhelm Kirch, MD, PhD · Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany

• David Pittrow, MD, PhD · Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany

• Michael Borte, MD, PhD · Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität Leipzig, Germany

• Ulrich Baumann, MD, PhD · Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule Hannover (MHH), Germany

• Manfred Hensel, MD, PhD · Mannheimer Onkologie Praxis, Mannheim, Germany

• Dörte Huscher · Epidemiologie, Rheumaforschungszentrum Berlin, Germany

• Marcel Reiser, MD, PhD · PIOH - Praxis Internistische Onkologie, Hämatologie, Köln, Germany

• Martin Stangel, MD, PhD · Klinik für Neurologie, Medizinische Hochschule Hannover (MHH), Germany

• Ralph Gold, MD, PhD · Klinik für Neurologie, St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Germany

• Claudia Sommer, MD, PhD · Neurologische Klinik und Poliklinik, Universitätsklinik Würzburg, Germany

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Germany

Study Locations