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Interleukin-1 Receptor Antagonist
Anakinra for Multiple Sclerosis
Phase 1 & 2
Waitlist Available
Led By Irene CM Cortese, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
Study Summary
This trial is testing whether the drug anakinra can help clear inflammation in MS brain lesions.
Eligible Conditions
- Multiple Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disappearance of one or all paramagnetic phase rims
Secondary outcome measures
9-hole peg test (9HPT)
Changes in T1 relaxation time within paramagnetic rim lesions at all time points, relative to non-rim lesions
Changes in size of paramagnetic rim lesions at all time points, relative to non-rim lesions
+4 moreSide effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Active treatmentExperimental Treatment1 Intervention
Patients with MS will be assigned to the same intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2240
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,339 Previous Clinical Trials
649,299 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
9,302 Patients Enrolled for Multiple Sclerosis
Irene CM Cortese, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
5 Previous Clinical Trials
804 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
32 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
4,325 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,325 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with multiple sclerosis (MS), whether it is stable or getting worse over time.You have a fear of enclosed spaces (like being in a small room) that would make it difficult for you to have an MRI scan.You cannot have used any other experimental drugs within the past month before screening.You have had asthma in the past.You have a current or recent (not including Multiple Sclerosis) cancer or another medical condition that requires medication to suppress or change your immune system.You have received previous treatment with anakinra or a TNF-receptor inhibitor.You have had a recurrence of your medical condition within the past year.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Active treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively seeking participants?
"According to clinicaltrials.gov, this experiment is currently recruiting participants. The study was initially posted on October 25th 2019 and its most recent update was November 10th 2022."
Answered by AI
What is the scope of participants in this investigation?
"Affirmative. Clinicaltrials.gov affirms that this clinical trial is actively recruiting patients, having been first posted on October 25th 2019 and recently updated November 10 2022--to enroll 10 participants at one location."
Answered by AI
What health conditions is Anakinra primarily employed to treat?
"Anakinra is a medication commonly prescribed to treat systemic juvenile idiopathic arthritis (sjia). Additionally, it may be effective for neonatal-onset multisystem inflammatory disease (nomid), interleukin 1 receptor antagonists and other steroid treatments."
Answered by AI
What precedent is there for Anakinra's efficacy in research studies?
"Currently, 33 clinical trials are ongoing to explore the potential of Anakinra. In particular, 7 experiments have advanced to Phase 3 testing, and they take place in Paris, Ile-De-France as well as 440 other sites around the world."
Answered by AI
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