Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4)
Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix 8)
Patients with high disease activity despite treatment with a disease modifying therapy (\> 1 relapse in the previous year, \> 9 hyperintense T2 lesions or \> 1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year)or patients with rapidly evolving severe RRMS (e.g. \> 2 relapses with disease progression in one year and \> 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI)
Depression according to ICD-10 criteria
Mild-moderate depression assessed by BDI-II score between 14-28 inclusively measured before study inclusion and before fingolimod is administered
You may not be if
Patients with a history of chronic disease of the immune system other than MS which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients with Crohns disease or ulcerative colitis are excluded without exception
History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin)
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests
Negative for varicella-zoster virus IgG antibodies at Screening
Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-β, glatiramer acetate); however no washout is needed for DMDs prior to start of fingolimod
Patients who are or have been treated with:
immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to start of fingolimod
Systemically applied corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to start of fingolimod (nevertheless, topical application is permitted);
Immunosuppressive medications such as azathioprine or methotrexate, within 3 months prior to start of fingolimod;
Cyclophosphamid and mitoxantrone within 6 months prior to start of fingolimod
cladribine at any time
current psychological or pharmacological treatment for depression (MAO inhibitors in particular), a washout period of 1 month prior start of fingolimod is required
current treatment with linezolid, a washout period of 1 month prior start of fingolimod is required
Clareo Health | Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression
