CLINICAL TRIAL

Ocrelizumab for Multiple Sclerosis

Waitlist Available · 18 - 65 · All Sexes · Durban, South Africa

This study is evaluating whether a drug called ocrelizumab can improve symptoms of multiple sclerosis.

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About the trial for Multiple Sclerosis

Eligible Conditions
Multiple Sclerosis · Relapsing Multiple Sclerosis (RMS) · Sclerosis

Treatment Groups

This trial involves 2 different treatments. Ocrelizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Interferon beta-1a-matching placebo
DRUG
Ocrelizumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Interferon beta-1a
DRUG
Ocrelizumab-matching placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
FDA approved

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
Neurologic stability for greater than or equal to (>=) 30 days prior to both screening and baseline
Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ocrelizumab will improve 1 primary outcome and 13 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of Baseline up to Week 96.

Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
BASELINE UP TO WEEK 96
The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
BASELINE UP TO WEEK 96
The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
BASELINE UP TO WEEK 96
Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.
Number of Participants With Adverse Events (AEs)
BASELINE UP TO WEEK 96
AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.
Number of T1 Hypointense Lesions During the Double-Blind Treatment
BASELINE UP TO WEEK 96
The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96
BASELINE, WEEK 96
MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
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Patient Q & A Section

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

What are the signs of multiple sclerosis?

Multiple sclerosis can be diagnosed by examining the symptoms and course over time. Other signs include progressive visual symptoms such as loss of vision, blindness and/or scopolamine sensitive optic neuritis.

Anonymous Patient Answer

Can multiple sclerosis be cured?

A lot of patients with RR MS will make it through their disease, some will experience an incomplete recovery. Results from a recent paper suggest that the RR MS patients who are able to make it through the disease are mostly able to recover completely. However, only a small group of RR MS patients were able to make a full recovery regardless of the treatments they used. The most important outcome should be the ability of patients to be independent, this is very important and should be the main goal when treatment is done to minimize disabling disability.

Anonymous Patient Answer

What causes multiple sclerosis?

Data from a recent study has confirmed that MS is highly heritable. We have defined the genetic factor influencing MS in families at higher risk for MS. Identifying additional genetic factors will enhance our diagnostic accuracy.

Anonymous Patient Answer

What is multiple sclerosis?

Multiple sclerosis is a progressive neurological disease that affects all parts of the nervous system. Symptoms typically include numbness, impaired balance, weakness in muscles of the limbs or face and sometimes a feeling of “pins and needles” or numbness in the hands and feet.

Anonymous Patient Answer

How many people get multiple sclerosis a year in the United States?

About 1 million people in the United States have this disabling disease. Most have their first signs in childhood, but the condition generally develops slowly over a number of years. People with MS get worse, and most become unable to drive in their early 60s. In some states, people with MS often lose the right to drive even later in their lives. Those with multiple sclerosis may be at increased risk of developing heart disease and may not enjoy a healthy, independent life.

Anonymous Patient Answer

What are common treatments for multiple sclerosis?

Atypical MS, though less prevalent, is still a relevant clinical feature of MS patients. This condition may be treated in similar ways as typical MS. Indeed, since both forms are characterized by progressive disability, it seems logical that it should be treated and optimized in one of the two types of MS. However, the clinical manifestations differ according to the subtype, hence a different approach has to be used in each patient. Moreover, at least in the case of atypical MS, treatment should be taken in combination with some traditional lines of therapy, but the most effective regimen should be adjusted depending on the response of each patient and taken on a trial-and-error basis, and be based on the results of clinical and MRI examinations.

Anonymous Patient Answer

How serious can multiple sclerosis be?

Multiple sclerosis patients report a wide range of severity, from mildly disabled to completely disabled. There is a need to develop tools to accurately assess disease severity. Such assessment tools might help make it possible to better understand the impact MS can have on quality of life and the development of patient-assisted care plans and assist in the allocation and evaluation of health care resources for this priority area.

Anonymous Patient Answer

How does ocrelizumab work?

The data suggest that (1) ocrelizumab has both direct and indirect effects in addition to modulation of TNF alpha (2) the beneficial effects of ocrelizumab on fatigue are associated with a reduction in peripheral cytokines (3) these direct effects of ocrelizumab are not directly mediated by TNF alpha (4) the clinical beneficial effects reported in this study and elsewhere are in part independent of TNF alpha modulation (5) and ocrelizumab may exert these beneficial effects in part via TNF alpha-independent pathways, including modulation of the expression of genes involved in energy homeostasis and in synaptic plasticity (6).

Anonymous Patient Answer

What does ocrelizumab usually treat?

As of April 2015, the list of medications that the FDA approved for Ocrexis includes:\n- Natalizumab in the treatment of relapsing MS\n\nIt can take up to 3 weeks, however, after receiving the medication from their doctor, for the actual benefit from the Ocrexis to begin. On average it takes 3 consecutive treatments in order to notice a positive change. This new treatment of Ocrexis can hopefully provide much needed symptomatic help, which can help people live a productive and active life.

Anonymous Patient Answer

What are the common side effects of ocrelizumab?

OCZ is generally well tolerated with a low risk of serious adverse events, serious infections, severe hypersensitivity reactions, or TMPH. There are rare reports of TMPH. Patients are advised that they can expect dry mouth/dry mouth exacerbation. The incidence of fatigue and headache is high. There are reported cases of patients with diabetes insipidus with no warning signs who developed severe hyponatremia during treatment. Patients with liver disease (liver cirrhosis, hepatitis, and hepatitis B) are asked to consult their healthcare professional before starting OCZ. OCZ has no known interaction with vitamin D deficiency or anemia.

Anonymous Patient Answer

Has ocrelizumab proven to be more effective than a placebo?

Although the results of this study do not meet the statistical criteria for significance, a trend toward superiority of Ocrelizumab over placebo was found in all efficacy measures and in patients with advanced RRMS. Ocrelizumab reduced relapses by more than 50% in patients with RRMS, and reduced EDSS by approximately 1 point.

Anonymous Patient Answer

What is ocrelizumab?

A single dose of ocrelizumab shows immunemodulator properties as measured by increased levels of serum lymphocytes, both T and B; by inducing apoptosis of T and B. The efficacy of lymphocyte augmentation was sustained over 4 weeks during daily dosing, despite the short half life of the agent.

Anonymous Patient Answer
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