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Non-interventional study for the assessment of fatigue, depression, and safety in patients with CIDP under longterm treatment with Gamunex® 10% - GAMEDIS

Non-interventional study for the assessment of fatigue, depression, and safety in patients with CIDP under longterm treatment with Gamunex® 10% - GAMEDIS - GAMEDIS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00003362
Enrollment
200
Registered
2012-02-01
Start date
2011-06-26
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic idiopathic demyelinating polyneuropathy G61.8

Interventions

Group 1: Patients with chronic idiopathic demyelinating polyneuropathy, who are treated with Gamunex in daily pratice, will be interviewed with questionnaires.

Sponsors

Grifols Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • diagnosed CIDP • signed informed consent • Patients who have completed or discontinued the non-interventional study are not allowed to be re-assigned into the protocoll of the extended observation period. Patients who finished the first study with one year observation period could enclosed to the second Study with 2 year observation period.

Exclusion criteria

Exclusion criteria: • selective IgA deficiency

Design outcomes

Primary

MeasureTime frame
• change of depression using the Beck Depression Index (BDI) at the beginning of the therapy and every 3 month (duration of observation up to: 144 weeks) • change of fatigue using the Fatigue Severity Scale (FSS) at the beginning of the therapy and every 3 month (duration of observation up to: 144 weeks)

Secondary

MeasureTime frame
• Therapeutic benefit assessed by the INCAT Score, WPAI-GH, SF-36 und Hughes Score at the beginning of the therapy and every 3 month (duration of observation up to: 144 weeks) • Safety by documentation of all AEs during this study

Countries

Germany

Contacts

Public ContactDaniel Militz

Grifols Deutschland GmbH

daniel.militz@grifols.com069-660593-100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026