Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RESI)

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis Read More

Inclusion Criteria:

• Voluntary participation in this study as proven by written informed consent
• Female or male patients with relapsing remitting MS according to McDon-ald-criteria (2010 revision) and decision for IFN-b treatment according to routine clinical criteria (not applying for healthy volunteers)
• Expanded Disability Status Scale (EDSS) between 0.0 and 6.0 (not applying for healthy volunteers)
• Naïve for IFN-b therapy (not applying for RRMS patients already under treatment)
• Age between 18 and 65 years
• Ability to follow study instructions and likely to attend and complete all required visits

• Adequate organ function as described below:

  • Adequate bone marrow reserve:

    • White blood cell (WBC) count ≥ 3000/µl,
    • granulocyte count > 1500/µl,
    • platelets ≥ 100000/µl,
    • haemoglobin ≥ 10 g/dl

  • Adequate liver function

    • bilirubin < 1.5 times above upper limit of normal range (ULN) (the higher concentrations are only allowed for patients with RRMS)
    • alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3 times ULN (the higher concentrations are only allowed for patients with RRMS)
  • Adequate renal function: creatinine < 1.5 times ULN (the higher concentrations are only allowed for patients with RRMS)
  • TSH within normal limits

  • Adequate blood clotting:

    • INR and PTT within normal limits
• Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the trial (Pearl index <1; Oral hormonal contraception must be used in combination with a barrier device due to elevated risk of nausea. Use of an intrauterine device made of copper is not allowed for healthy volunteers due to MRI)
• Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
• MRI study: only healthy participants

Exclusion Criteria:

• Subjects not able to give consent
• Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
• Patients suffering from a form other than relapsing remitting Multiple Sclerosis (not applying for healthy volunteers)
• Patients with a MS relapse within 30 days before study inclusion
• EDSS >6.0 (not applying for healthy volunteers)
• Patients with known allergy or hypersensitivity to Interferon-beta or ingredients of the injection solution
• Subjects with a physical or psychiatric condition/ a systemic disease which at the investigator's discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject's participation in this clinical trial or may prevent sufficient compliance
• Known or persistent abuse of medication, drugs or alcohol
• Prior malignancy (unless adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer). If prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence the subject can be enrolled at the discretion of the investigator
• Prior chemotherapy, systemic or local treatment with DNA-damaging and immune-modulating agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
• History of major depression, suicide attempt in the past, ongoing suicidal thoughts
• Cardiac insufficiency (NYHA III or IV), cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease, or significant hypertension at rest (BP > 180/110 mmHg)
• HIV, Hepatitis B or C infection or any relevant infectious disease which might interfere with the study procedures and results (at the discretion of the investigator)
• Women who are pregnant or breast-feeding
• Comedication with corticosteroids
• Female Patients with reproductive potential who do not accept to use contraception during the trial and 3 months thereafter
• Treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days but at least 5 times the half life of the IMP before enrolment
• Very poor peripheral veins and pronounced fear of blood drawings
• Patients with history of epileptic seizures and / or under medical therapy with antiepileptic drugs
• MRI study: Metal implants (eg pacemaker, inner-ear prosthesis, nerve stimulator, implanted defibrillator, infusion pump, artificial joints), wearing of magnetic or metallic objects that cannot be removed from the body (such as body piercing, dental prosthesis, implanted electrodes, contraceptive coil, acupuncture needle), tattoos & permanent makeup, claustrophobia, tinnitus, inability to lie on the back for an extended period of time, previous surgery on heart or head