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

This study is currently recruiting participants.
Verified April 2013 by Dresden University of Technology
Sponsor:
Collaborator:
GWT-TUD GmbH
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01287689
First received: January 24, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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 among at least 550 subjects 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.


Condition Intervention
Primary Immunodeficiency (PID)
Secondary Immunodeficiency (SID)
Neurological Autoimmune Disease
 Other: Immunoglobulin G (IgG)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Immunoglobulin IgG dosage [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Dosage of immunoglobulins (IgG); frequency of IgG administrations; days of treatment with IgG; duration of infusion of IgG.


Secondary Outcome Measures:
  • Infection rate [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]

    For immunodeficiencies (primary PID and secondary SID):

    frequency of infections; degree of severity of infections (SBIs); duration of antibiotic treatment; necessity of antibiotic treatment.


  • Neurological and muscular function (for neurological auto-immune diseases only) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Grip strength (dynamometer) Electrophysiology (EMG, ENG); INCAT disability scale; EDSS, annual relapse rate; Myasthenia Score.

  • Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only). [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Pharmacoeconomic parameters [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 650
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient treated with any IgG
Any marketed SC or IV IgG can be documented
 Other: Immunoglobulin G (IgG)
Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory or hospital-based patients (no age restriction)

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287689

Contacts
Contact: David Pittrow, MD, PhD. +49351458 ext 2815 david.pittrow@mailbox.tu-dresden.de

Locations
Germany
Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ. Recruiting
Bochum, Germany
Contact: Ralf Gold, MD, PhD            
Principal Investigator: Ralf Gold, MD, PhD            
Institute for Clinical Pharmacology Recruiting
Dresden, Germany, D-01307
Contact: Wilhelm Kirch, MD, PhD     +49351458 ext 2008     wilhelm.kirch@mailbox.dresden.de    
Principal Investigator: Wilhelm Kirch, MD, PhD            
Klinik für Neurologie, Medizinische Hochschule Recruiting
Hannover, Germany
Contact: Martin Stangel, MD, PhD            
Principal Investigator: Martin Stangel, MD, PhD            
Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule (MHH). Recruiting
Hannover, Germany
Contact: Ulrich Baumann, MD, PhD            
Principal Investigator: Ulrich Baumann, MD, PhD            
Praxis für Hämatologie und Internistische Onkologie Recruiting
Köln, Germany
Contact: Marcel Reiser, MD, PhD            
Principal Investigator: Marcel Reiser, MD, PhD            
Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität Recruiting
Leipzig, Germany
Contact: Michael Borte, MD, PhD            
Principal Investigator: Michael Borte, MD, PhD            
Sub-Investigator: Maria Fasshauer, MD            
Mannheimer Onkologie-Praxis Recruiting
Mannheim, Germany
Contact: Manfred Hensel, MD, PhD            
Principal Investigator: Manfred Hensel, MD, PhD            
Sponsors and Collaborators
Dresden University of Technology
GWT-TUD GmbH
Investigators
Principal Investigator: Wilhelm Kirch, MD, PhD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Study Chair: David Pittrow, MD, PhD Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany
Study Director: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01287689     History of Changes
Other Study ID Numbers: SIGNS
Study First Received: January 24, 2011
Last Updated: April 29, 2013
Health Authority: Germany: Paul-Ehrlich Institut (PEI)

Keywords provided by Dresden University of Technology:
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

Additional relevant MeSH terms:
Autoimmune Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulin G
Immunoglobulins
 Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013