Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

Exclusion Criteria

• •Pregnancy or current breastfeeding
• •Use of another investigational agent within 1 month of screening
• •Active infection and or neutropenia (ANC \< 1000 cells/microliter)
• •History of lymphoma
• •Known hypersensitivity to administration of anakinra
• •Previous treatment with anakinra and/or TNF-receptor inhibitor
• •History of asthma
• •QuantiFERON-TB gold positive
• •Prior treatment with anti-CD20 agent (ocrelizumab, rituximab)
• •Prior treatment with anti-CD52 agent (alemtuzumab)
• •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with participation for the full duration of the trial; or not in the best interest of the subject to participate, in the opinion of the treating investigator
• •Renal dysfunction, as defined by Clinical Center guidelines for administration of gadolinium
• •Liver dysfunction, as indicated by baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal
• •Clinical relapse in the 12 months prior to dosing
• •New lesion formation (by comparison of screening MRI to a previous MRI of sufficient quality) in the 3 months prior to dosing
• •One or more gadolinium-enhancing lesions on the screening scan
• •Change in disease-modifying therapy in the 6 months prior to dosing
• •Medical contraindication for 7-tesla MRI (including, but not limited to, any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings, that are not MRI-compatible or cannot be removed)
• •Psychological contraindication for 7-tesla MRI (e.g., claustrophobia)
• •Contraindication to gadolinium administration.
• •Active neoplastic disease or any medical condition, other than MS, that requires concurrent immunosuppression or immunomodulation