Ravulizumab for Myasthenia Gravis
(OCTAGON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of ravulizumab for individuals with generalized myasthenia gravis (gMG), a condition that causes muscle weakness. Researchers aim to determine if they can safely reduce oral steroid use in these patients without worsening symptoms. Participants will follow a plan to gradually lower their steroid intake while continuing ravulizumab treatment. Individuals who have been taking a specific amount of oral steroids and are already receiving ravulizumab may be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how ravulizumab can benefit more patients with gMG.
What is the safety track record for ravulizumab and prednisone/prednisolone?
Studies have shown that ravulizumab is generally safe for people with generalized myasthenia gravis (gMG). In one study, most patients experienced improvements; specifically, out of 160 people, 88% had better scores on a test measuring daily activities. Another study found that ravulizumab quickly improved both patient and doctor assessments and maintained those improvements. Side effects were mild and not serious.
The FDA has already approved ravulizumab for other uses, suggesting it is well-tolerated. This approval adds confidence in its safety for treating gMG. Overall, research indicates that ravulizumab is a promising option with a good safety record.12345Why are researchers enthusiastic about this study treatment?
Ravulizumab is unique because it targets the complement system, specifically inhibiting the C5 protein, which plays a role in the immune response associated with myasthenia gravis symptoms. This is different from standard treatments like acetylcholinesterase inhibitors and immunosuppressants, which generally focus on enhancing neuromuscular transmission or dampening the overall immune system response. Researchers are excited about Ravulizumab because it offers a more targeted approach, potentially leading to fewer side effects and improved symptom control by directly addressing the underlying cause of the autoimmune attack rather than broadly suppressing the immune system.
What is the effectiveness track record for ravulizumab in treating myasthenia gravis?
Research shows that ravulizumab, the primary treatment in this trial, effectively treats generalized myasthenia gravis (gMG). In earlier studies, 88.1% of patients taking ravulizumab experienced significant symptom improvement. By Week 26, these patients improved by an average of 2.8 points, compared to only 0.8 points for those on a placebo. Improvements appeared within one week and lasted at least 26 weeks. In this trial, participants will follow an oral corticosteroid tapering schedule, as ravulizumab has reduced the need for oral corticosteroids, commonly used to manage gMG symptoms.14678
Are You a Good Fit for This Trial?
Adults over 18 with generalized Myasthenia Gravis (gMG) who are already being treated with Ravulizumab can join. They must be on a stable dose of oral corticosteroids like prednisone and willing to try tapering off these steroids. Women able to have children need a negative pregnancy test before starting.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow an oral corticosteroid tapering schedule while receiving intravenous ravulizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisone/Prednisolone
- Ravulizumab
Trial Overview
The study is testing if adults with gMG can safely reduce their use of oral corticosteroids, which are commonly used for treatment, by following a specific tapering schedule while continuing treatment with the intravenous drug Ravulizumab.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexion Pharmaceuticals, Inc.
Lead Sponsor
Dr. Alberto R. Martinez
Alexion Pharmaceuticals, Inc.
Chief Medical Officer since 2010
MD from University of Sao Paulo
Marc Dunoyer
Alexion Pharmaceuticals, Inc.
Chief Executive Officer since 2021
PhD in Molecular Biology
Citations
Long‐Term Efficacy and Safety of Ravulizumab in Adults ...
One hundred and forty‐one out of 160 (88.1%) patients achieved a ≥ 2‐point improvement in MG‐ADL total score, and 59/141 (41.8%) achieved a ...
Outcomes for Patients with Generalized Myasthenia Gravis ...
Conclusions: Despite varying patient characteristics, results suggest both treatments improved patient outcomes and decreased OCS dosing.
Clinical Results With ULTOMIRIS® | gMG
At Week 26, the average change in total score from baseline was -2.8 for people receiving ULTOMIRIS and -0.8 for those receiving placebo. Many people continued ...
Terminal Complement Inhibitor Ravulizumab in Generalized ...
Ravulizumab demonstrated rapid and sustained improvements in both patient- and clinician-reported outcomes and had a side effect and adverse- ...
Efficacy | ULTOMIRIS® (ravulizumab-cwvz) | gMG
Improvements in MG-ADL total scores from baseline were observed within 1 week of treatment and sustained through Week 26.1,2,a. ULTOMIRIS demonstrated efficacy ...
Effectiveness and Safety of Ravulizumab in Generalized ...
To assess updated effectiveness and safety data for the complement protein C5 inhibitor therapy (C5IT) ravulizumab among patients with gMG in routine clinical ...
Study Details | NCT06909253 | Ravulizumab Treatment ...
The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that ...
First analysis of the Myasthenia Gravis SPOTLIGHT Registry
The objectives of this Registry study were to evaluate the safety and effectiveness of eculizumab and ravulizumab for the treatment of patients ...
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