Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
NCT ID: NCT01287689
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
685 participants
OBSERVATIONAL
2010-07-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient treated with any IgG
Any marketed SC or IV IgG can be documented
Immunoglobulin G (IgG)
Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented.
Interventions
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Immunoglobulin G (IgG)
Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented.
Eligibility Criteria
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Inclusion Criteria
* Naïve to IgG, or pre-treated with IgG
* Subject or parent/legally authorized representative has provided written informed consent.
Exclusion Criteria
ALL
No
Sponsors
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GWT-TUD GmbH
OTHER
Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Wilhelm Kirch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
David Pittrow, MD, PhD
Role: STUDY_CHAIR
Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany
Michael Borte, MD, PhD
Role: STUDY_DIRECTOR
Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität Leipzig, Germany
Ulrich Baumann, MD, PhD
Role: STUDY_DIRECTOR
Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule Hannover (MHH), Germany
Manfred Hensel, MD, PhD
Role: STUDY_DIRECTOR
Mannheimer Onkologie Praxis, Mannheim, Germany
Dörte Huscher
Role: STUDY_DIRECTOR
Epidemiologie, Rheumaforschungszentrum Berlin, Germany
Marcel Reiser, MD, PhD
Role: STUDY_DIRECTOR
PIOH - Praxis Internistische Onkologie, Hämatologie, Köln, Germany
Martin Stangel, MD, PhD
Role: STUDY_DIRECTOR
Klinik für Neurologie, Medizinische Hochschule Hannover (MHH), Germany
Ralph Gold, MD, PhD
Role: STUDY_DIRECTOR
Klinik für Neurologie, St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Germany
Claudia Sommer, MD, PhD
Role: STUDY_DIRECTOR
Neurologische Klinik und Poliklinik, Universitätsklinik Würzburg, Germany
Locations
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Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ.
Bochum, , Germany
Praxis für Hämatologie und Internistische Onkologie
Cologne, , Germany
Institute for Clinical Pharmacology
Dresden, , Germany
Klinik für Neurologie, Medizinische Hochschule
Hanover, , Germany
Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule (MHH).
Hanover, , Germany
Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität
Leipzig, , Germany
Mannheimer Onkologie-Praxis
Mannheim, , Germany
Countries
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References
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Kirch W, Gold R, Hensel M, Fasshauer M, Pittrow D, Huscher D, Reiser M, Stangel M, Baumann U, Borte M. [Assessment of immunoglobulins in a long-term non-interventional study (SIGNS Study). Rationale, design, and methods]. Med Klin (Munich). 2010 Sep;105(9):647-51. doi: 10.1007/s00063-010-1105-8. Epub 2010 Sep 28. German.
Borte M, Baumann U, Pittrow D, Hensel M, Fasshauer M, Huscher D, Reiser M, Stangel M, Gold R, Kirch W; Liste der aktuell beitragenden Zentren, sortiert nach Postleitzahlen (mindestens ein Patient zum 1.3.2012). [Immunoglobulins in PID, SID and neurological autoimmune disease]. Dtsch Med Wochenschr. 2012 Mar;137(13):675-80. doi: 10.1055/s-0032-1304844. Epub 2012 Mar 20. German.
Stangel M, Baumann U, Borte M, Fasshauer M, Hensel M, Huscher D, Kirch W, Pittrow D, Reiser M, Gold R. Treatment of neurological autoimmune diseases with immunoglobulins: first insights from the prospective SIGNS registry. J Clin Immunol. 2013 Jan;33 Suppl 1:S67-71. doi: 10.1007/s10875-012-9789-6. Epub 2012 Sep 14.
Stangel M, Gold R, Pittrow D, Baumann U, Borte M, Fasshauer M, Hensel M, Huscher D, Reiser M, Sommer C. Treatment of patients with multifocal motor neuropathy with immunoglobulins in clinical practice: the SIGNS registry. Ther Adv Neurol Disord. 2016 May;9(3):165-79. doi: 10.1177/1756285616629869. Epub 2016 Feb 16.
Reiser M, Borte M, Huscher D, Baumann U, Pittrow D, Sommer C, Stangel M, Fasshauer M, Gold R, Hensel M. Management of patients with malignancies and secondary immunodeficiencies treated with immunoglobulins in clinical practice: Long-term data of the SIGNS study. Eur J Haematol. 2017 Aug;99(2):169-177. doi: 10.1111/ejh.12900. Epub 2017 Jun 21.
Other Identifiers
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SIGNS
Identifier Type: -
Identifier Source: org_study_id
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