Multiple Sclerosis, Relapsing-RemittingINCIDENT-MSNCT04450030
Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within past years. However, evidence defining the exact role of apheresis treatment in the therapeutic sequence is still incomplete. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Methyl Prednisolonate and Immunoadsorption
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute relapsing multiple sclerosis that were refractory to a first course of intravenous methyl prednisolone (1000mg per day for three to five consecutive days)
Who may be able to join
- Signed informed consent form
- Diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised McDonald-criteria
- Incomplete remission of relapse symptoms following initiation treatment with 1000mg/d intravenous methyl prednisolone
- Absence of fever or clinically apparent signs of infection
Who cannot join
- Baseline EDSS score >6.5 points
- Previous administration of less than 3x1000mg or more than 5x1000mg IVMPS for initiation treatment
- Known pregnancy or rejection to perform a pregnancy test (female patients only)
- Immunosuppressive treatment for conditions other than multiple sclerosis
- Ongoing neoplastic disorder or past neoplastic disorder within previous five years
- Known or newly diagnosed HIV-, HBV- or HCV-infection
- Regular intake of ACE inhibitor drugs
- Known bleeding disorders (including laboratory abnormalities such as: (I) platelet count<50.000/µL; (II) international normalized ratio>1.5, (III) activated prothrombin time>50s) or intake of oral anticoagulant drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology with Institute of Translational Neurology, University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action
Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within past years. However, evidence defining the exact role of apheresis treatment in the therapeutic sequence is still incomplete. INCIDENT-MS evaluates the mechanism of action of immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory MS relapses and thereby will help to identify predictive markers for optimal treatment choice and will generate further insights into the pathophysiology of MS relapses.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Methyl Prednisolonate, Immunoadsorption
- Keywords
- immunoadsorption, intravenous methyl prednisolone
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl PrednisolonateDrug
2000mg intravenous methyl prednisolone per day for five consecutive days
ImmunoadsorptionProcedure or surgery
6 courses of tryptophane-based immunoadsorption within up to 12 days
| Study group | Role | What they receive |
|---|---|---|
| Intravenous methyl prednisolone | Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse Receives: Drug: Methyl Prednisolonate | |
| Immunoadsorption | Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse Receives: Procedure: Immunoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded disability status scale (EDSS)
Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values
Measured: 2 weeks
Secondary outcomes (6)
visual-evoked potentials (VEP; P100-latency)
Evolution of VEP P100-latency compared to peak relapse values
Measured: 2 weeks; 6 to 8 weeks
somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Evolution of SEP N20-/P40-latency compared to peak relapse values
Measured: 2 weeks; 6 to 8 weeks
best-corrected visual acuity (bcVA)
Evolution of bcVA compared to peak relapse values
Measured: 2 weeks; 6 to 8 weeks
Expanded disability status scale (EDSS)
Confirmation of improvement of disability compared to primary endpoint
Measured: 6 to 8 weeks
Multiple scleroris functional compositie (MSFC)
Development of MSFC z-score compared to peak relapse values
Measured: 2 weeks, 6 to 8 weeks
Short form-36 questionaire (SF-36)
Development of quality-of-life compared to peak relapse values
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Aug 2018
- Primary completion5 Sep 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven G Meuth, Prof Dr, Principal investigator, University Hospital Muenster, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450030
- Sponsor's protocol ID
- INCIDENTMS2018
- Acronym
- INCIDENT-MS
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfeuffer S, Rolfes L, Wirth T, Steffen F, Pawlitzki M, Schulte-Mecklenbeck A, Gross CC, Brand M, Bittner S, Ruck T, Klotz L, Wiendl H, Meuth SG. Immunoadsorption versus double-dose methylprednisolone in refractory multiple sclerosis relapses. J Neuroinflammation. 2022 Sep 7;19(1):220. doi: 10.1186/s12974-022-02583-y.
PubMed 36071461
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action
- ClinicalTrials.gov ID
- NCT04450030
- Acronym / sponsor ID
- INCIDENT-MS / INCIDENTMS2018
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- immunoadsorption, intravenous methyl prednisolone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Jun 2020 (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.
Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within past years. However, evidence defining the exact role of apheresis treatment in the therapeutic sequence is still incomplete. INCIDENT-MS evaluates the mechanism of action of immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory MS relapses and thereby will help to identify predictive markers for optimal treatment choice and will generate further insights into the pathophysiology of MS relapses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous methyl prednisolone | – | Drug: Methyl PrednisolonatePatients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse |
| Immunoadsorption | – | Procedure: ImmunoadsorptionPatients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute relapsing multiple sclerosis that were refractory to a first course of intravenous methyl prednisolone (1000mg per day for three to five consecutive days)
Key inclusion criteria (4 listed)
- Signed informed consent form
- Diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised McDonald-criteria
- Incomplete remission of relapse symptoms following initiation treatment with 1000mg/d intravenous methyl prednisolone
- Absence of fever or clinically apparent signs of infection
Key exclusion criteria (8 listed)
- Baseline EDSS score >6.5 points
- Previous administration of less than 3x1000mg or more than 5x1000mg IVMPS for initiation treatment
- Known pregnancy or rejection to perform a pregnancy test (female patients only)
- Immunosuppressive treatment for conditions other than multiple sclerosis
- Ongoing neoplastic disorder or past neoplastic disorder within previous five years
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 |
|---|---|---|
| Methyl Prednisolonate2000mg intravenous methyl prednisolone per day for five consecutive days | Drug | Intravenous methyl prednisolone |
| Immunoadsorption6 courses of tryptophane-based immunoadsorption within up to 12 days | Procedure or surgery | Immunoadsorption |
Primary outcome
Expanded disability status scale (EDSS)
Time frame: 2 weeks
Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values
6 secondary outcomes
visual-evoked potentials (VEP; P100-latency)
Time frame: 2 weeks; 6 to 8 weeks
somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Time frame: 2 weeks; 6 to 8 weeks
best-corrected visual acuity (bcVA)
Time frame: 2 weeks; 6 to 8 weeks
Expanded disability status scale (EDSS)
Time frame: 6 to 8 weeks
Multiple scleroris functional compositie (MSFC)
Time frame: 2 weeks, 6 to 8 weeks
Short form-36 questionaire (SF-36)
Time frame: 6 to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 36071461Pfeuffer S, Rolfes L, Wirth T, Steffen F, Pawlitzki M, Schulte-Mecklenbeck A, Gross CC, Brand M, Bittner S, Ruck T, Klotz L, Wiendl H, Meuth SG. Immunoadsorption versus double-dose methylprednisolone in refractory multiple sclerosis relapses. J Neuroinflammation. 2022 Sep 7;19(1):220. doi: 10.1186/s12974-022-02583-y.
- Individual participant dataSharing planned: No
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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.
Sven G Meuth, Prof Dr principal investigator
University Hospital Muenster, 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, Relapsing-Remitting, run by University Hospital Muenster at 1 site in Germany.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Nov 2020. 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 Germany. 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?
Results are not available in the source record.
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?
Expanded disability status scale (EDSS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450030, which also lists 1 linked publication.
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 12 Nov 2020.