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Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? - A Prospective Observational Fatigue Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria

• Age 18-65 years

• Stable MS disease at inclusion (definition: no clinical relapse, no MRI activity, stable disability within the last 12 months)

• Unchanged immunotherapy within the last 12 months

• Expanded Disability Status Scale (EDSS) level \<4 points indicating fully ambulatory patients.

• Capability of written informed consent

Locations
Other Locations
Switzerland
University Hospital of Bern Inselspital
RECRUITING
Bern
Contact Information
Primary
Lara Diem, MD
larafrancesca.diem@insel.ch
0041316327000
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 106
Treatments
MS patients with IgG deficiency (serum IgG-concentration <7g/L).
MS patients with IgG deficiency (serum IgG-concentration \<7g/L).
MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).
MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov