InRIMS: Prospective Stratification of Infectious Risks in Multiple Sclerosis

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04036097

Collaborator

Swiss Multiple Sclerosis Society (Other), Bangerter-Rhyner Stiftung (Other), Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany (Other)

254

Enrollment

Location

35.7

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: MS-adapted AWIS questionnaire (MS-AWIS) Other: infection diary (MS-AWIS diary)

Study Design

Study Type:

Observational

Anticipated Enrollment :

254 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)

Actual Study Start Date :

Apr 10, 2019

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

AWIS RTI score [Baseline]
AWIS RTI score is based on the data collected with the MS-adapted AWIS (MS-AWIS) questionnaire; score varies between 0 (no RTI burden) and 50 (maximal RTI burden)
infection diary score [24 months]
monthly diary RTI score, averaging ten RTI symptom categories with the coding "0" for "no infection reported", "1" for "reported infection with duration < 2 weeks", and "2" for "reported infection present with duration >2 weeks

Secondary Outcome Measures

Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs [24 months]
Comparison of infection scores between patients receiving DMTs and those who do not receive DMTs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study

Exclusion Criteria:

Not able to sufficiently understand the patient information and questionnaire (German language)
MS Patients with long-term antibiotic prophylaxis
MS Patients with known primary immunodeficiency, under chemotherapy due to any malignancy or HIV infection.