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

Technische Universität Dresden

Status

Completed

Conditions

Primary Immunodeficiency (PID)

Neurological Autoimmune Disease

Secondary Immunodeficiency (SID)

Treatments

Other: Immunoglobulin G (IgG)

Study type

Observational

Funder types

Other

Identifiers

NCT01287689

SIGNS

Details and patient eligibility

About

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.

Full 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.

Enrollment

685 patients

Sex

All

Volunteers

No Healthy Volunteers

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