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Ocrelizumab for Multiple Sclerosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hospital San Raffaele, Milano, ItalyMultiple SclerosisOcrelizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for people who have gotten ocrelizumab in a previous study and are continuing treatment or in a follow-up phase.

Eligible Conditions
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

2
Ocrelizumab
1
Ocrelizumab
2
Ocrelizumab

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 44 months

Up to 44 months
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
Week 0
Change in 9-Hole Peg Test (9HPT) over time
Change in Expanded Disability Status Scale (EDSS) score over time
Change in Timed 25-Foot Walk Test (T25FWT) over time
The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
The number of T1 lesions and number of new or enlarging T2 lesions

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

3
Ocrelizumab
2
Ocrelizumab
3
Ocrelizumab

Side Effects for

Ocrelizumab
31%Infusion related reaction
14%Upper respiratory tract infection
13%Urinary tract infection
11%Nasopharyngitis
8%Headache
7%Depression
6%Arthralgia
6%Back pain
5%Sinusitis
5%Insomnia
5%Fatigue
4%Influenza like illness
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT01247324) in the Ocrelizumab ARM group. Side effects include: Infusion related reaction with 31%, Upper respiratory tract infection with 14%, Urinary tract infection with 13%, Nasopharyngitis with 11%, Headache with 8%.

Trial Design

1 Treatment Group

Ocrelizumab
1 of 1

Experimental Treatment

1300 Total Participants · 1 Treatment Group

Primary Treatment: Ocrelizumab · No Placebo Group · Phase 3

Ocrelizumab
Drug
Experimental Group · 1 Intervention: Ocrelizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2020
Completed Phase 3
~3990

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 44 months

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,374 Previous Clinical Trials
1,067,613 Total Patients Enrolled
32 Trials studying Multiple Sclerosis
16,144 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,155 Previous Clinical Trials
875,489 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
16,471 Patients Enrolled for Multiple Sclerosis

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
New York100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I have multiple sclerosis"
How many prior treatments have patients received?
3+100.0%
References

Frequently Asked Questions

What are the chances of negative side effects from Ocrelizumab?

"The available evidence suggests that Ocrelizumab is safe to use, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

How many different hospitals are testing this new medication?

"This trial is currently underway at 31 locations, including Hope Research Institute in Phoenix, MultiCare Health System Institute for Research and Innovation in Tacoma, and SUNY at Stony Brook in Stony Brook." - Anonymous Online Contributor

Unverified Answer

When will recruitment for this research project be completed?

"The sponsor, Hoffmann-La Roche, needs to recruit 1300 eligible patients from various locations, including Hope Research Institute in Phoenix, Arizona and MultiCare Health System Institute for Research and Innovation in Tacoma, Washington." - Anonymous Online Contributor

Unverified Answer

Are people still allowed to sign up for this experiment?

"Yes, this trial is still looking for participants. The information on clinicaltrials.gov shows that the trial was posted on 5/3/2022 and was last updated on 10/17/2022. They are looking for 1300 people to participate at 31 different locations." - Anonymous Online Contributor

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

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