Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis
Immunodeficiency other than hypogammaglobulinemia
Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy
Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) >16 points)
Trial population
Multiple Sclerosis Patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laboratory test
Diagnostic testFrequency of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: MS patients with IgG deficiency (serum IgG-concentration <7g/L).1 intervention
Group B: MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with fatigue and hypogammaglobulinemia
The primary endpoint will be measured as frequency (%) of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency (IgG serum concentration \<7.0 g/L) compared to those with normal IgG-serum concentration (≥ 7.0 g/L). The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue) FSMC Sum Score: ≥ 43 points mild fatigue, ≥ 53 points moderate fatigue, ≥ 63 severe fatigue
Time frame
1.5 years2
Number of patients with fatigue without hypogammaglobulinemia
The primary endpoint will be measured as frequency (%) of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency (IgG serum concentration \<7.0 g/L) compared to those with normal IgG-serum concentration (≥ 7.0 g/L). The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue) FSMC Sum Score: ≥ 43 points mild fatigue, ≥ 53 points moderate fatigue, ≥ 63 severe fatigue
Time frame
1.5 yearsSecondary outcomes
1
Fatigue and infections
As secondary endpoint the frequency of infections (infection/months) in MS patients will be measured and compared between those with (IgG serum concentration \<7.0 g/L) and without hypogammaglobulinemia (IgG serum concentration ≥ 7.0 g/L). Furthermore, the mediation of fatigue by "frequency of infections\*" will be detailed in the cohort of MS patients with hypogammaglobulinemia. \*A telephone interview with 6 questions about the frequency of infections will take place once a month.
Time frame
1.5 yearsSponsors and contacts
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Source ClinicalTrials.gov