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

July 31, 2017 updated by: Technische Universität Dresden

An Open, Uncontrolled, Non-interventional Observational Cohort Outcome Study of Immunoglobulins in 3 Indications: Primary and Secondary Immunodeficiencies and Neurological Auto-immune Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ambulatory or hospital-based patients (no age restriction)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 54 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 54 months
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.
up to 54 months
Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only).
Time Frame: up to 54 months
up to 54 months
Health-related quality of life
Time Frame: up to 54 months
up to 54 months
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
up to 54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2010

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGNS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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