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Monoclonal Antibodies

Satralizumab for Neuromyelitis Optica

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
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 up to39 months
Awards & highlights

Study Summary

This trial will study the long-term effects of satralizumab on patients with NMOSD. Those who have completed previous studies on the drug will be given it again either alone or with another immunosuppressive treatment.

Who is the study for?
This trial is for people with Neuromyelitis Optica Spectrum Disorder who were previously in studies BN40898 or BN40900, are on satralizumab, and either tested positive for AQP4-IgG antibodies or are deemed to benefit from continued treatment. Women must not be pregnant, breastfeeding, or planning pregnancy soon.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of satralizumab alone or with immunosuppressants (azathioprine, mycophenolate mofetil) or oral steroids in NMOSD patients. It's an open-label study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Satralizumab may cause infections, potential allergic reactions at the infusion site, headache, joint pain and nausea. When combined with other immunosuppressants or steroids, there might be increased risk of infection and other immune-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to39 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs
Secondary outcome measures
Annualized Relapse Rate (ARR)
Change in Expanded Disability Status Scale (EDSS) Score
Change in Visual Acuity Assessed by a Snellen 20-Foot Wall Chart
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Satralizumab TreatmentExperimental Treatment4 Interventions
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mycophenolate mofetil (MMF)
2007
Completed Phase 4
~350

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,935 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
12 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,383 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
12 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders

Media Library

Satralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04660539 — Phase 3
Neuromyelitis Optica Spectrum Disorders Research Study Groups: Satralizumab Treatment
Neuromyelitis Optica Spectrum Disorders Clinical Trial 2023: Satralizumab Highlights & Side Effects. Trial Name: NCT04660539 — Phase 3
Satralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660539 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical clinics is this trial being run today?

"This trial has 15 active locations, these are: Jefferson Hospital For Neuroscience; Jefferson Neurology Associates in Philadelphia, Centre hospitalier de l'Universite de Montreal (CHUM) in Montreal, University of Miami in Miami, and other sites."

Answered by AI

Are new patients being accepted into this research trial?

"The clinical trial in question is no longer recruiting patients, as per the information available on clinicaltrials.gov. This study was initially posted on March 2nd, 2021 and last updated September 12th, 2022. There are, however, 173 other trials that are currently open to enrolment."

Answered by AI

Could you please provide a list of other clinical trials that have used satralizumab?

"Currently, there are one hundred and forty-nine clinical trials underway which involve satralizumab. Of those active studies, twenty have reached Phase 3. The majority of these trials are located in Philadelphia, Pennsylvania; however, there are one thousand and twenty-eight different trial sites for this medication."

Answered by AI

Could you elaborate on the possible dangers of satralizumab?

"There is existing clinical data that suggest satralizumab's efficacy and safety, so it was given a score of 3."

Answered by AI

How many test subjects are involved in this clinical trial?

"Currently, this trial is not looking for new participants. It was first posted on March 2nd 2021 and updated September 12th 2022. 24 other trials involving neuromyelitis optica are currently searching for candidates and 149 studies regarding satralizumab are also open."

Answered by AI

For what maladies is satralizumab commonly given to patients?

"The list of autoimmune diseases that satralizumab can help ameliorate includes multiple sclerosis, lupus nephritis, and transplant rejection."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
New York
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
2021. "A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04660539.
~3 spots leftby May 2024
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