Autoimmune diseases which needs an immunoglobulin treatment - including dermatomyositis, polymyositis, inclusion body myositis, MMN, CIDP Skin and Connective Tissue Diseases
Conditions
Interventions
The study will be conducted in adult patients (>18 years old) treated with Gammanorm® for a autoimmune disease, such as chronic inflammatory demyelinating polyradiculoneuropathy, multifocal motor neur
Sponsors
Octapharma France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient 2. Patient with an autoimmune disease like CIDP, MMN, Polymyositis, Dermatomyositis, Inclusion body myositis, necrotizing myopathy or other autoimmune dideases 3. Patient treated by Gammanorm® 4. Patient had given oral consent after patient information note
Exclusion criteria
Exclusion criteria: 1. Patient with Gammanorm® and with primary or secondary immunodeficiency 2. Patient does not wish to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events, by counting and evaluating these events as soon as they occur. The physician completes the Adverse event declaration page in the eCRF and this adverse event is automatically declared in pharmacovigilance. information coklected includes: 1. Type of event 2. The outcomes 3. Severity 4. Duration 5. The link with Gammanorm 6. Actions (stop of the treatment, corrective treatment,...) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy of treatment: 1.1. For ITP (Immune Thrombocytopenic Purpura ) : SMOG Score and echography of spleen 1.2. For NMM (Multifocal motor neuropathy) and CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) : Rankin modified score, and MRC (Medical research council of Great Britain) and ONLS (Overall Neuropathy Limitation Scale) 1.3. For dermatomyositis, Polymyositis or Inclusion body myositis or necrotic myositis : a muscular testing, a myostis functional scale 2. Treatment compliance and therapeutic regimen, monitored using the following data: 2.1. Dosage for a month 2.2. Number of perfusions during a week 2.3. Dosage (in g/kg) 2.4. Speed infusion 2.5. Batch numbers 2.6. Number of vials since the last visit 3. Evaluate patient satisfaction (LQI scale) and quality of life (SF12 scale) Measured at baseline and then every 3 months and at study end. | — |
Countries
France
Outcome results
None listed