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

NCT01287689 | Completed

• 1 other identifier: SIGNS
• Study Type: observational
• Target: 685
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Non-interventional trial; immunodeficiency; outcome study, registry; long-term outcomes, drug utilization; effectiveness, treatment patterns; patient characteristics under real life conditions; factors for treatment success; long-term tolerability; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Infection rate

  up to 54 months

• Neurological and muscular function (for neurological auto-immune diseases only)

  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

  up to 54 months

Study Arms (1)

Patient treated with any IgG

Any marketed SC or IV IgG can be documented

Other: Immunoglobulin G (IgG)

Interventions

Immunoglobulin G (IgG) OTHER

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

Patient treated with any IgG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory or hospital-based patients (no age restriction)

You may qualify if:

• Subjects of either gender with primary, severe secondary immunodeficiency and recurrent infections or neurological autoimmune diseases
• Naïve to IgG, or pre-treated with IgG
• Subject or parent/legally authorized representative has provided written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Technische Universität Dresden: lead
• GWT-TUD GmbH: collaborator

Study Sites (7)

Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ.

Bochum, Germany

Location

Praxis für Hämatologie und Internistische Onkologie

Cologne, Germany

Location

Institute for Clinical Pharmacology

Dresden, D-01307, Germany

Location

Klinik für Neurologie, Medizinische Hochschule

Hanover, Germany

Location

Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule (MHH).

Hanover, Germany

Location

Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität

Leipzig, Germany

Location

Mannheimer Onkologie-Praxis

Mannheim, Germany

Location

Related Publications (5)

• 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.

  PMID: 20878302 BACKGROUND

• 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.

  PMID: 22434180 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.

  PMID: 22976553 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.

  PMID: 27134672 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.

  PMID: 28467615 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Interventions

Immunoglobulin G

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: February 1, 2011
• Study Start: July 1, 2010
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

DE (7)