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Completed

NCT Number: NCT01287689

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

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.

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Key information

Conditions

Primary Immunodeficiency (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Neurological Autoimmune Disease Primary Immunodeficiency Diseases Secondary Immunodeficiency (SID)

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunoglobulin G (IgG)

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • GWT-TUD GmbH

Registry information

Official study title

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

Acronym: SIGNS

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2011
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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