MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS

Karolinska Institutet0 个研究点目标入组 150 人开始时间: 2017年7月6日最近更新: 2017年11月6日

适应症

试验速览

暂无简介。

•? 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

•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.

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