Infusion Day: 6 months - 600Mg Ocrelizumab

I got to the Neurologist's office around 8:15am, and did an array of tests to start out the morning. Pretty much the same routine as the last 2 infusions, except for the fact that they deliver the entire dose of 600mg in one day, versus having them split up like the first dose. Eye test, physical from the doctor, EDSS scoring which included the walking test. I was over 3 minutes slower than last time. I had to fill out a questionnaire and do a couple of blood sugar tests. They take your blood pressure, pulse and temperature for some baselines. After all the initial tests, they start an IV and give you 100mg of solu-medrol which is the brand name fo the Methylprednisolone streroid. Then they give you some Tylenol and some Benadryl. There is about a 30 minute waiting period and then they start the Ocrelizumab infusion, which started around 11:30am. During the start of the infusion, they take the blood pressure, pulse, and temperature every 15 minutes to ensure that everything is ok.

Weight: 252
EDSS Score: 4.5

MRI Results: Blind report, no acute findings and nothing new to report.

 

Volume and Rates at which the drug is administered:

20ml - 30 minutes - 40ml/hr
42.5ml - 29 minutes - 85ml/hr
65ml - 29 minutes - 134ml/hr
84.5ml - 29 minutes - 169ml/hr
100ml - 94 minutes - 200ml/hr

Vitals throughout the day:

Time	Blood Pressure	Pulse	Temp
10:30 AM	123/79	76	98.8
11:00 AM	119 / 77	70	98.5
11:30 AM*	128/74	70	98.4
	120/75	70	98.4
	129/74	68	98.2
	115/72	71	98.5
	119/78	82	98.9
	126/68	85	98.9
	119/77	82	98.9
	121/72	88	98.9
3:44 PM	121/74	86	98.8
	134/76	89	98.8
4:30 PM	119/79	89	98.7
	Average:	78.9	98.67

The infusion finished around 3:30pm.  Temperature remained pretty steady all day with an average of 98.67 degrees.  The average pulse for the day was 78.9.  They did give me a naproxen equivalent to taking 2 Aleve as a preventative measure.  They checked the vitals a few more times and was able to "walk" out the door at 4:35pm.  I was at the office for a little more than 8 hours total, with 4 hours getting the infusion.

Not sure if I mentioned this before, but they recommend that you drink lots of water before getting the infusion.  I started upping my water intake a few days ago, but also chugged a huge water bottle this morning before everything started.  Because of this, you have to bring the trolley and pump that is giving you the drug with you when you visit the restroom.  Somewhat awkward, but better than the alternative.  No, they do not go into the restroom with you, but they do stand guard outside the door!

Next infusion is June 22nd!

A Study of Ocrelizumab: Phase III - CHORDS MN30085

I thought that I would post additional information about the study that I am participating in.  All of this material is on the clinicaltrials.gov website, and is subject to change at any time.

Sponser:  Genentech            clinicaltrials.gov Identifier:  NCT02637856

As of this blog post, this study is still looking for participants.

Purpose:  This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligram (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion every 24 weeks for the study duration. Anticipated time on study treatment is 96 weeks.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS WHO HAVE HAD A SUBOPTIMAL RESPONSE TO AN ADEQUATE COURSE OF DISEASE MODIFYING TREATMENT

Primary Outcome Measures:

• Percentage of Participants Without Any Protocol-Defined Events (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) During 96-Week Period [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Percentage of Participants Without Any Protocol-Defined Events (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) During 24-Week Period and 48-Week Period [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
• Time to Protocol-Defined Event (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Percentage of Participants Per Year with Protocol-Defined Relapse [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First Protocol-Defined Relapse [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First T1 Gadolinium (Gd)-Enhanced Lesion as Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of Confirmed Disability Progression for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
• Change From Baseline in Total T2 Lesion Volume Detected by Brain MRI [ Time Frame: Baseline to Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
• Total Number of New and/or Enlarging T2 Lesions Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

• Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
• Disease duration from first symptom of less than or equal to (</=) 10 years
• Treated with or received no more than two prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent DMT was due to lack of efficacy
• Suboptimal disease control while the participant was on his/her last DMT for >/=6 months (defined by having one of the following despite being on a stable dose of the same DMT for >/=6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); in participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT

Exclusion Criteria:

• History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
• Contraindications for MRI
• Known presence of other neurological disorders that may mimic multiple sclerosis
• Pregnancy or lactation
• Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• History of or currently active primary or secondary immunodeficiency
• Lack of peripheral venous access
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Active infection, or history of or known presence of recurrent or chronic infection such as hepatitis B or C, human immunodeficiency virus (HIV), syphilis, or tuberculosis
• History of progressive multifocal leukoencephalopathy
• Contraindications to or intolerance of oral or IV corticosteroids

Additional information can be found on the clinicaltrials.gove website for study NCT02637856

***All information on this page is from https://clinicaltrials.gov/ct2/show/NCT02637856

My First Ocrelizumab Infusion!

Today is the day!  I started out by having a conversation with the Neurologist and physical exam.  This office currently has 7 people on this drug, but everyone else is part of the original OPERA trials.  I am patient number 1 on the CHORDS study for this office, which is from a company called Genentech with a Protocol number of MN30035.  They have 3 others that are queued up behind me.  My doctor told me that this drug should deplete my B Cells, but has an added effect of stimulating stem cell regeneration.  Those stem cells are thought to then have the positive effect of reducing the lesions that cause MS.  He said that if my condition doesn't get any worse, then this is a success.  If it gets better, then it is a grand slam.  I've waited over 7 months to get this drug, and my optimism is high.  Here is the purpose of the study:

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligram (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion every 24 weeks for the study duration. Anticipated time on study treatment is 96 weeks.

Initial Vitals:

• Weight 252.6  
• Initial Blood pressure 124/79
• My EDSS score today is 4.0.

Started out taking 50mg Benadryl and 500mg Tylenol, followed by a 100mg Solu-Medrol (Methylprenisolone) steroid infusion.  I did not  initially get sleepy from the Benedryl, and didn't really notice anything with the steroid drip either.  In the last 30 minutes of the Ocrelizumab infusion, I did doze off for a few minutes and did have some minor spasms in my left leg.

The Ocrelizumab on the first visit is administered over a period of 2.5 hours, for a total of 300mg.
It is sensitive to light, so the drug is covered.  They change the flow rate of the drug 5 times, with the volume increasing with each level until the 300mg is gone.

Volume	Minutes	Rate
16ml	30	32ml/hr
32.5ml	29	65ml/hr
48.5ml	29	97ml/hr
64.5ml	29	129ml/hr
97ml	29	194ml/hr

My body temperature was normal all day, and didn't spike at all.  My blood pressure did drop for the first few readings, but then came up.

• 122/73
• 119/77
• 113/75
• 100/69
• 123/73
• 135/74
• 140/76
• 134/72
• 123/74
• 113/73

I did have them check to see my EDSS scores from the previous Gileyna trial I was on.  In July of 2014, it was 2.0.  In July of 2015, it was 2.5.  So, a 4.0 shows that I am deteriorating.  I'm anxious to see if this number remains stable, or gets better!

During the infusion process, if you have to go to the bathroom, they have you bring the infusion trolley with you.  I brought lunch, and tons of things to do, but spend most of my time online on my iPad writing this post.  After the infusion is complete, they have you sit around for an hour to ensure there are no problems.  I did not have any side effects from the infusion.  My body temp stayed stable, and I didn't get any rashes.  I was able to drive myself home without incident.  I go back in 2 weeks for the 2nd 300mg.  

Reduction in lesions?

I have read through enough articles about Ocrelizumab to get excited just due to the possibility of reducing the number of brain lesions. In the phase II study, 220 people with relapsing remitting multiple sclerosis had reductions in the total number of brain lesions detected by MRI scans with 96 percent of people who had the 2,000mg dosage and 89 percent who had the 600mg dosage, compared to placebo. Additionally, the annualized relapse rate was reduced by 80 percent compared to placebo for those on the 600mg dosage.  (73% for the 2,000mg)

Just the idea of being able to reduce the number of lesions, or stopping new ones from forming is exciting. I realize that this is still a long journey for me, and I may not see results, if any, for a while.  I tell people that I'm cautiously optimistic, and that I feel lucky that I get to participate in this study.  On the MS SubReddit, I had questions on how I was able to get involved with Ocrelizumab.  Honestly, I was proactive and asked my Neurologist, and said that I really wanted this drug. We went down the path of getting approved for Lemtrada as an alternative while waiting for this opportunity, but I'm glad that I was accepted to the study. I am patient number one for this specific research facility, and I know that there are 2 more queued right behind me. Less than a week away until I get started.