Status:
COMPLETED
Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may b...
Detailed Description
Objective: The overall goal of this study is to determine the safety, tolerability, and radiological efficacy of up to 12 weeks of subcutaneous injection of anakinra in people with multiple sclerosis...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18
- Ability to give informed consent
- If fertile, agreement to use an effective method of birth control during the study and for up to 3 months after the last dose of the study drug
- Agreement not to participate in any other interventional study while participating in this protocol
- Diagnosis of MS, either stable or clinically progressive
- Prior 7-tesla MRI scan, with high image quality in the judgment of the study neuroradiologist, demonstrating at least one white matter lesion with a paramagnetic rim (41)
- 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
Exclusion
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04025554
Start Date
October 25 2019
End Date
October 24 2023
Last Update
December 27 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892