Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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6 November 2017 |
Main ID: |
EUCTR2017-002634-24-SE |
Date of registration:
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06/07/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.
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Scientific title:
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MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS |
Date of first enrolment:
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29/09/2017 |
Target sample size:
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150 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002634-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: prospective cohort trial
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 8
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Neurology Clinic
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Address:
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Neurologkliniken R3:4
171 76
Stockholm
Sweden |
Telephone:
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00460851773757 |
Email:
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fredrik.piehl@ki.se |
Affiliation:
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Karolinska University Hospital |
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Name:
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Neurology Clinic
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Address:
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Neurologkliniken R3:4
171 76
Stockholm
Sweden |
Telephone:
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00460851773757 |
Email:
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fredrik.piehl@ki.se |
Affiliation:
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Karolinska University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: ? 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.
? Having given written informed consent prior to undertaking any study-related procedures.
? Are expected to be capable to follow study assessments and have decision-making capacity, e.g. lucid and oriented x 4 (time, place, situation and person) as judged by the investigator; and
? Are aged =18 years and = 50 years at the day of signing the informed consent for inclusion into the study, and
? In case of fertile women, have been given information on potential DMT-related teratogenic effects and what type of contraception is considered safe according to respective summaries of product characteristics (SmPC). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 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)
?Conditions/situations such as:
- Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint (e.g. pre-existing neurological disease, systemic autoimmune diseases) - A requirement for concomitant treatment that could bias primary evaluation - An impossibility to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol, patient suffering from conditions that make MRI analysis impossible e.g pacemaker claustrophobia) - The patient is the Investigator or a sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol - Is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures - Pregnant or breast-feeding women - subjects with conditions listed as contraindications to the use of medicinal products used in the trial, e.g. gadolinium used for MRI scans. - ongoing participation in other trials with blinded study medication or that interfere with the study protocol.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive)
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: Mabthera Pharmaceutical Form: Infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 500-1000
Trade Name: Tysabri Pharmaceutical Form: Infusion INN or Proposed INN: NATALIZUMAB CAS Number: 189261-10-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-
Trade Name: Tecfidera Pharmaceutical Form: Capsule INN or Proposed INN: DIMETHYL FUMARATE CAS Number: 624-49-7 Other descriptive name: DIMETHYL FUMARATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 240-
Trade Name: Gilenya Pharmaceutical Form: Tablet INN or Proposed INN: FINGOLIMOD CAS Number: 162359-55-9 Other descriptive name: FINGOLIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5-
Trade Name: Copaxone Pharmaceutical Form: Injection INN or Proposed INN: GLATIRAMER ACETATE CAS Number: 147245-92-9 Other descriptive name: GLATIRAMER ACETATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 20-40
Trade Name: Betaferon Pharmaceutical Form: Injection INN or Proposed INN: INTERFERON BETA-1B CAS Number: 145155-23-3 Other descriptive name: INTERFERON BETA-1B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Trade Name: Extavia Pharmaceutical Form: Injection INN or Proposed INN: INTERFERON BETA-1B CAS Number: 145155-23-3 Other descriptive name: INTERFERON BETA-1B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Trade Name: Avonex Pharmaceutical Form: Injection INN or Proposed INN: INTERFERON BETA-1A CAS Number: 220581-49-7 Other descriptive name: INTERFERON BETA-1A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30-
Trade Name: Rebif Pharmaceutical Form: Injection INN or Proposed INN: INTERFERON BETA-1A CAS Number: 220581-49-7 Other descriptive name:
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Primary Outcome(s)
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Secondary Objective: 1) Discover and validate biomarkers for disease, progression and treatment response in MS. 2) Gain in-depth knowledge of distinct pathogenic pathways to allow identification of targets for novel treatments
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Main Objective: 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.
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Primary end point(s): 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.
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Timepoint(s) of evaluation of this end point: MRI scans performed at baseline and after 24 months of treatment.
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Secondary Outcome(s)
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Secondary end point(s): 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).
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Timepoint(s) of evaluation of this end point: regularly monitored during the lenght of the study
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Secondary ID(s)
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MultipleMS
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Source(s) of Monetary Support
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Department of Clinical Neuroscience, Karolinska Institutet
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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