Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases

Octapharma

Status: Terminated

Conditions: Autoimmune Diseases

Treatments: Drug: Gammanorm

Study type: Observational

Funder types: Industry

Identifiers

NCT03656640

IMMUNORM

Details and patient eligibility

About

This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult man or woman older than 18 years,
2. Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®,
3. Patient who has a prescription of Gammanorm® treatment for immunomodulation,
4. Patient accepting to participate in the study by oral consent after having received oral and written information on the study.

Exclusion criteria

1. Patient treated with Gammanorm® for immune substitution, or other authorized use
2. Patient who refuses to participate in the study.

Trial design

60 participants in 1 patient group

Patients Receiving Gammanorm®

Description:

Patients Receiving Gammanorm®

Treatment:

Drug: Gammanorm