MultipleMS – a study with the aim to accelerate personalised medicine
MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients.
What it found
We found no results in the registry or in papers.
What was tested
Compared with
- Rituximab
B-lymphocyte antigen CD20 binding agent
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Fingolimod
- Glatiramer acetate
Unknown
- Interferon beta-1b
Interferon alpha/beta receptor agonist
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
- Alemtuzumab
CAMPATH-1 antigen inhibitor
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
What it measured
Main measures
The primary endpoint in this study will be association of the MultipleMS risk score with the number of new and enlarging T2 lesions in brain and spinal cord that occur over a period of two years.
MRI lesions
Other measures (1)
Association of the MultipleMS risk score with clinical and other MRI endpoints (e.g. No evident disease activity (NEDA3R, NEDA4 [20]), relapse rate, EDSS progression, changes in Multiple Sclerosis Functional Composite (MSFC)(only 25-foot walk and 9 hole-peg tests) [21], LCVA and SDMT).
Disability progressionRelapsesMRI lesionsThinking and memoryWalking and mobility
Who could take part
Relapsing and progressive
Show the full criteria
Inclusion criteria
Inclusion: Male and female patients between the age of 18 and 50 years with CIS (meeting the requirements of dissemination in space) or MS (both relapsing remitting and primary progressive) according to the valid McDonald criteria diagnosed within the last two years and before the initiation of immunotherapy. Corticosteroid therapy for treatment of relapses is allowed if the treatment was stopped at least 1 month before inclusion in the study. Exclusion: Patients who have met all the above inclusion criteria who at inclusion have the following characteristics are excluded from study participation: Under any administrative or legal supervision or unable to give informed consent. Previous treatment with immunomodulatory or immunosuppressive drugs (including corticosteroid therapy of relapses if given one month prior inclusion)
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The main objective of the MultipleMS is to develop novel personalised medicine approaches for MS patients. To this end we will identify a combination of evidence-based selection of clinical, biological, and lifestyle features to develop a risk-score that can predict the clinical course, stratify patients based on their risk and the therapeutic response to the existing DiseaseModifyingTreatments.
Papers
Loading reviews and guidelines…
History
Started
Jul 2017