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

Primary Immunodeficiency (PID) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autoimmune Diseases
• Immunologic Deficiency Syndromes
• Neoplasm Metastasis
• Neurological Autoimmune Disease
• Primary Immunodeficiency (PID)
• Secondary Immunodeficiency (SID)

• NCT number: NCT01287689
• Study type: Observational [Patient Registry]
• Source: Technische Universität Dresden
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Completion date: December 31, 2016