Spots Global Cancer Trial Database for Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
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Trial Identification
Brief Title: Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
Official Title: An Open, Uncontrolled, Non-interventional Observational Cohort Outcome Study of Immunoglobulins in 3 Indications: Primary and Secondary Immunodeficiencies and Neurological Auto-immune Diseases
Study ID: NCT01287689
Interventions
Study Description
Brief 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinik fĂźr Neurologie, St. Josefs-Hospital der Ruhr-Univ., Bochum, , Germany
Institute for Clinical Pharmacology, Dresden, , Germany
Klinik fĂźr Neurologie, Medizinische Hochschule, Hannover, , Germany
Klinik fßr Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule (MHH)., Hannover, , Germany
Praxis fßr Hämatologie und Internistische Onkologie, KÜln, , Germany
Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität, Leipzig, , Germany
Mannheimer Onkologie-Praxis, Mannheim, , Germany
Contact Details
Name: Wilhelm Kirch, MD, PhD
Affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: David Pittrow, MD, PhD
Affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany
Role: STUDY_CHAIR
Name: Michael Borte, MD, PhD
Affiliation: Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität Leipzig, Germany
Role: STUDY_DIRECTOR
Name: Ulrich Baumann, MD, PhD
Affiliation: Klinik fßr Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule Hannover (MHH), Germany
Role: STUDY_DIRECTOR
Name: Manfred Hensel, MD, PhD
Affiliation: Mannheimer Onkologie Praxis, Mannheim, Germany
Role: STUDY_DIRECTOR
Name: DĂśrte Huscher
Affiliation: Epidemiologie, Rheumaforschungszentrum Berlin, Germany
Role: STUDY_DIRECTOR
Name: Marcel Reiser, MD, PhD
Affiliation: PIOH - Praxis Internistische Onkologie, Hämatologie, KÜln, Germany
Role: STUDY_DIRECTOR
Name: Martin Stangel, MD, PhD
Affiliation: Klinik fĂźr Neurologie, Medizinische Hochschule Hannover (MHH), Germany
Role: STUDY_DIRECTOR
Name: Ralph Gold, MD, PhD
Affiliation: Klinik fßr Neurologie, St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Germany
Role: STUDY_DIRECTOR
Name: Claudia Sommer, MD, PhD
Affiliation: Neurologische Klinik und Poliklinik, Universitätsklinik Wßrzburg, Germany
Role: STUDY_DIRECTOR
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