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| Name | Class |
|---|---|
| GWT-TUD GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated with any IgG | Any marketed SC or IV IgG can be documented |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin G (IgG) | Other | Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin IgG dosage | Dosage of immunoglobulins (IgG); frequency of IgG administrations; days of treatment with IgG; duration of infusion of IgG. | up to 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate | For immunodeficiencies (primary PID and secondary SID): frequency of infections; degree of severity of infections (SBIs); duration of antibiotic treatment; necessity of antibiotic treatment. | up to 54 months |
| Neurological and muscular function (for neurological auto-immune diseases only) |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory or hospital-based patients (no age restriction)
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| Name | Affiliation | Role |
|---|---|---|
| Wilhelm Kirch, MD, PhD | Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany | Principal Investigator |
| David Pittrow, MD, PhD | Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany | Study Chair |
| Michael Borte, MD, PhD | Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität Leipzig, Germany | Study Director |
| Ulrich Baumann, MD, PhD | Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule Hannover (MHH), Germany | Study Director |
| Manfred Hensel, MD, PhD | Mannheimer Onkologie Praxis, Mannheim, Germany | Study Director |
| Dörte Huscher | Epidemiologie, Rheumaforschungszentrum Berlin, Germany | Study Director |
| Marcel Reiser, MD, PhD | PIOH - Praxis Internistische Onkologie, Hämatologie, Köln, Germany | Study Director |
| Martin Stangel, MD, PhD | Klinik für Neurologie, Medizinische Hochschule Hannover (MHH), Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ. | Bochum | Germany | ||||
| Praxis für Hämatologie und Internistische Onkologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20878302 | Background | 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. | |
| 22434180 |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Grip strength (dynamometer) Electrophysiology (EMG, ENG); Inflammatory Neuropathy Cause and Treatment (INCAT) disability score; EDSS, annual relapse rate; Myasthenia Score. |
| up to 54 months |
| Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only). | up to 54 months |
| Health-related quality of life | up to 54 months |
| Pharmacoeconomic parameters | 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 | up to 54 months |
| Study Director |
| Ralph Gold, MD, PhD | Klinik für Neurologie, St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Germany | Study Director |
| Claudia Sommer, MD, PhD | Neurologische Klinik und Poliklinik, Universitätsklinik Würzburg, Germany | Study Director |
| Cologne |
| Germany |
| Institute for Clinical Pharmacology | Dresden | D-01307 | 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 |
| 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. |
| 22976553 | Result | 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. |
| 27134672 | Result | 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. |
| 28467615 | Result | 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. |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |