Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT04025554|
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 26, 2020
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 be inflamed for a long time. This causes MS to progress. There is no treatment for these lesions. Researchers believe that a drug that decreases inflammation can help.
To see if a drug called anakinra can help clear inflammation in MS brain lesions.
People 18 and older with MS and at least one white matter lesion.
Participants will be screened with one or more Neuroimmunology Clinic protocols.
Participants will have a medical history and physical exam. They will have blood and urine tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.
Participants will repeat the above procedures throughout the study.
Participants will get their first dose of anakinra at the clinic. They will administer the rest of the doses themselves, by injection under the skin.
Participants will track their daily dosage electronically or in a written drug diary.
Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty vials will be collected.
Participants will have 2 follow-up visits after completing treatment.
The study will last 28 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Anakinra||Phase 1 Phase 2|
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 and evidence, by magnetic resonance imaging (MRI), of chronic active (also known as smoldering ) lesions in the white matter.
5 people with progressive or stable MS, at least one paramagnetic rim lesion on 7-tesla MRI, and no new white matter lesion formation for at least 3 months or clinical relapse for at least 12 months, will complete the study.
In this open label, dose escalation study, participants will receive up to 12 weeks of
subcutaneous anakinra with initial dose of 100 mg daily up to a target dose of 300 mg daily. Study visits will occur every 4 weeks while on treatment, with 2 follow-up visits at 4 and 12 weeks after discontinuation.
The primary outcome measure is disappearance of one or more paramagnetic rims from white matter lesions identified at baseline. Secondary outcomes include safety and tolerability, clinical and radiological outcomes. Exploratory serological and CSF measures will also be obtained to investigate mechanism of action of anakinra and for biomarker development.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis|
|Actual Study Start Date :||October 25, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: 1/Active treatment
Patients with MS will be assigned to the same intervention
100 mg daily weeks 1-4, 200 mg daily weeks 5-8, 300 mg daily weeks 9-12.
- Disappearance of one or all paramagnetic phase rims [ Time Frame: At baseline and every 4 weeks ]Assessment of paramagnetic phase rims by scans.
- Safety and tolerability [ Time Frame: 28 weeks ]Monitoring of AEs
- Expanded Disability Status Scale (EDSS) [ Time Frame: Every 4 weeks for the duarion of study ]Clinical assessment
- 9-hole peg test (9HPT) [ Time Frame: Every 4 weeks for the duarion of study ]Clinical assessment
- Symbol digit modalities test (SDMT) [ Time Frame: Every 4 weeks for the duarion of study ]Clinical assessment
- Proportion of paramagnetic rim lesions in which the rim has diminished or disappeared at any time point [ Time Frame: Every 4 weeks for the duarion of study ]MRI scan
- Changes in T1 relaxation time within paramagnetic rim lesions at all time points, relative to non-rim lesions [ Time Frame: Every 4 weeks for the duarion of study ]MRI scan
- Changes in size of paramagnetic rim lesions at all time points, relative to non-rim lesions [ Time Frame: Every 4 weeks for the duarion of study ]MRI scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025554
|Contact: Joan M Ohayon, C.R.N.P.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Irene CM Cortese, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|