Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
- Conditions
- Neurological Autoimmune DiseaseSecondary Immunodeficiency (SID)Primary Immunodeficiency (PID)
- Interventions
- Other: Immunoglobulin G (IgG)
- Registration Number
- NCT01287689
- Lead Sponsor
- Technische Universität Dresden
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 685
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient treated with any IgG Immunoglobulin G (IgG) Any marketed SC or IV IgG can be documented
- Primary Outcome Measures
Name Time Method Immunoglobulin IgG dosage 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
Name Time Method Infection rate 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.Health-related quality of life up to 54 months Neurological and muscular function (for neurological auto-immune diseases only) up to 54 months Grip strength (dynamometer) Electrophysiology (EMG, ENG); Inflammatory Neuropathy Cause and Treatment (INCAT) disability score; EDSS, annual relapse rate; Myasthenia Score.
Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only). up to 54 months Pharmacoeconomic parameters 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
Trial Locations
- Locations (7)
Institute for Clinical Pharmacology
🇩🇪Dresden, Germany
Klinik für Neurologie, St. Josefs-Hospital der Ruhr-Univ.
🇩🇪Bochum, Germany
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