NCT03656640TerminatedNot Applicable
A Prospective, Multicenter Observational Trial Assessing the Safety and Efficacy of Gammanorm® in Autoimmune Diseases
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Octapharma
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.
Study Overview
Brief Summary
This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult man or woman older than 18 years,
- •Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®,
- •Patient who has a prescription of Gammanorm® treatment for immunomodulation,
- •Patient accepting to participate in the study by oral consent after having received oral and written information on the study.
Exclusion Criteria
- •Patient treated with Gammanorm® for immune substitution, or other authorized use
- •Patient who refuses to participate in the study.
Arms & Interventions
Patients Receiving Gammanorm®
Patients Receiving Gammanorm®
Intervention: Gammanorm (Drug)
Outcomes
Primary Outcomes
Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.
Time Frame: 24 months
Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.
Secondary Outcomes
- Evaluate treatment compliance(24 months)
- Evaluate reasons for stopping the treatment(24 months)
- Rankin score(24 months)
- MRC(24 months)
- SMOG score(24 months)
- Muscular Testings and Myositis Functional Rating Scale(24 months)
- ONLS(24 months)
- Patient Quality of Life regarding Gammanorm(24 months)
- Patient satisfaction regarding Gammanorm(24 months)
Investigators
Study Sites (3)
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