Multiple SclerosisInRIMSNCT04036097
Prospective Stratification of Infectious Risks in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MS-adapted AWIS questionnaire (MS-AWIS) and infection diary (MS-AWIS diary)
- How many people
- 298 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Apr 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MS patients participating in the SMSC or SUMMIT study with or without DMT
Who may be able to join
- Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Neurology
Basel, 4031
About this study
Official title: Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)
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.
- Conditions
- Multiple Sclerosis
- Being tested
- MS-adapted AWIS questionnaire (MS-AWIS), infection diary (MS-AWIS diary)
- Keywords
- secondary immunodeficiencies, disease-modifying treatments (DMT), immunosuppressive therapy, serious infection, respiratory tract infections (RTI), urinary tract infections, infection diary, Swiss MS Cohort (SMSC), SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies
- Medical subject headings
- Multiple Sclerosis, Respiratory Tract Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-adapted AWIS questionnaire (MS-AWIS)Other
The predefined questionnaire-based infection score of the Airway Infection Susceptibility (AWIS) study is predictive for the occurrence of respiratory tract infections (RTI). In addition several MS-specific items (e.g. bladder dysfunction and urinary tract infections) are included into the AWIS questionnaire (MS-AWIS).
infection diary (MS-AWIS diary)Other
MS patients prospectively fill out monthly infection diaries for 24 months. Infection diaries will either be sent back (with pre-franked envelopes) or handed back to the InRIMS-study team during regular clinical visits (usually every 6 or 12 months).
What is being measured
The primary outcome is the main question the study is designed to answer.
AWIS RTI score
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)
Measured: Baseline
infection diary score
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
Measured: 24 months
Secondary outcomes (1)
Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs
Comparison of infection scores between patients receiving DMTs and those who do not receive DMTs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start10 Apr 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Multiple Sclerosis Society, Bangerter-Rhyner Stiftung, Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
- Responsible party
- Sponsor
- Investigators
- Bernhard Décard, Dr. med, Principal investigator, University Hospital Basel, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036097
- Sponsor's protocol ID
- 2019-00465; me18Decard
- Other IDs
- 2019
- Acronym
- InRIMS
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2019
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)
- ClinicalTrials.gov ID
- NCT04036097
- Acronym / sponsor ID
- InRIMS / 2019-00465; me18Decard
- Conditions
- Multiple Sclerosis
- Keywords
- secondary immunodeficiencies, disease-modifying treatments (DMT), immunosuppressive therapy, serious infection, respiratory tract infections (RTI), urinary tract infections, infection diary, Swiss MS Cohort (SMSC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Multiple Sclerosis Society, Bangerter-Rhyner Stiftung, Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients participating in the SMSC or SUMMIT study with or without DMT
Key inclusion criteria (1 listed)
- Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-adapted AWIS questionnaire (MS-AWIS)The predefined questionnaire-based infection score of the Airway Infection Susceptibility (AWIS) study is predictive for the occurrence of respiratory tract infections (RTI). In addition several MS-specific items (e.g. bladder dysfunction and urinary tract infections) are included into the AWIS questionnaire (MS-AWIS). | Other | – |
| infection diary (MS-AWIS diary)MS patients prospectively fill out monthly infection diaries for 24 months. Infection diaries will either be sent back (with pre-franked envelopes) or handed back to the InRIMS-study team during regular clinical visits (usually every 6 or 12 months). | Other | – |
Primary outcome
AWIS RTI score
Time frame: 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
Time frame: 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
1 secondary outcome
Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Décard, Dr. med principal investigator
University Hospital Basel, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AWIS RTI score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.