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

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ClinicalTrials.gov Identifier: NCT01287689
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


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

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.

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 685 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : July 2010
Primary Completion Date : December 31, 2016
Study Completion Date : December 31, 2016


Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Immunoglobulin IgG dosage [ Time Frame: up to 54 months ]
    Dosage of immunoglobulins (IgG); frequency of IgG administrations; days of treatment with IgG; duration of infusion of IgG.


Secondary Outcome Measures :
  1. Infection rate [ Time Frame: up to 54 months ]

    For immunodeficiencies (primary PID and secondary SID):

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


  2. Neurological and muscular function (for neurological auto-immune diseases only) [ Time Frame: up to 54 months ]
    Grip strength (dynamometer) Electrophysiology (EMG, ENG); Inflammatory Neuropathy Cause and Treatment (INCAT) disability score; EDSS, annual relapse rate; Myasthenia Score.

  3. Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only). [ Time Frame: up to 54 months ]
  4. Health-related quality of life [ Time Frame: up to 54 months ]
  5. Pharmacoeconomic parameters [ Time Frame: up to 54 months ]
    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


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287689


Locations
Germany
Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ.
Bochum, Germany
Institute for Clinical Pharmacology
Dresden, Germany, D-01307
Klinik für Neurologie, Medizinische Hochschule
Hannover, Germany
Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule (MHH).
Hannover, Germany
Praxis für Hämatologie und Internistische Onkologie
Köln, Germany
Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg gGmbH Leipzig, Akademisches Lehrkrankenhaus der Universität
Leipzig, Germany
Mannheimer Onkologie-Praxis
Mannheim, Germany
Sponsors and Collaborators
Technische Universität Dresden
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

Publications:

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01287689     History of Changes
Other Study ID Numbers: SIGNS
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Technische Universität Dresden:
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:
Neoplasm Metastasis
Immunologic Deficiency Syndromes
Autoimmune Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs