Study regarding the safety of Gammanorm in autoimmune diseases

Completed

Conditions: Autoimmune diseases which needs an immunoglobulin treatment - including dermatomyositis, polymyositis, inclusion body myositis, MMN, CIDP
Skin and Connective Tissue Diseases

Registration Number: ISRCTN32265704

Lead Sponsor: Octapharma France

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

1. Patient with Gammanorm® and with primary or secondary immunodeficiency
2. Patient does not wish to participate

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events, by counting and evaluating these events as soon as they occur.<br><br>The physician completes the Adverse event declaration page in the eCRF and this adverse event is automatically declared in pharmacovigilance.<br> information coklected includes:<br>1. Type of event<br>2. The outcomes<br>3. Severity<br>4. Duration<br>5. The link with Gammanorm<br>6. Actions (stop of the treatment, corrective treatment,...)

Secondary Outcome Measures

Name	Time	Method
1. Efficacy of treatment:<br>1.1. For ITP (Immune Thrombocytopenic Purpura ) : SMOG Score and echography of spleen<br>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)<br>1.3. For dermatomyositis, Polymyositis or Inclusion body myositis or necrotic myositis : a muscular testing, a myostis functional scale<br>2. Treatment compliance and therapeutic regimen, monitored using the following data:<br>2.1.Dosage for a month<br>2.2.Number of perfusions during a week<br>2.3.Dosage (in g/kg)<br>2.4.Speed infusion<br>2.5.Batch numbers<br>2.6.Number of vials since the last visit<br>3. Evaluate patient satisfaction (LQI scale) and quality of life (SF12 scale)<br><br>Measured at baseline and then every 3 months and at study end.