“I just go back from a meeting in Boston where I heard that recruitment for the PPMS ocrelizumab study is behind schedule and going very slowly. Why? All I hear about on these pages is how we the research community are ignoring and neglecting progressive MS, in particular PPMS. Where are all the PPMS’ers?”
The following is a précis of the inclusion and exclusion criteria.
www.clinicaltrials.gov: A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
Inclusion Criteria:
- Adult patients, 18-55 years of age
- Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
- Expanded Disability Status Scale (EDSS) 3 to 6.5 points
- Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
- Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Exclusion Criteria:
- History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
- Contraindications for Magnetic Resonance Imaging (MRI)
- Known presence of other neurologic disorders
- Known active infection or history of or presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
- Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
If you think you fulfill the inclusion criteria for this trial please speak to your neurologist about the possibility of being referred for screening for this study.
“It is in everybody’s interest for this trial to recruit quickly.”
CoI: (1) The Royal London Hospital is a site in this trial (principal investigator Dr Klaus Schmierer). (2) Prof. Giovannoni is a member of the steering committee that oversees the running of this trial.
Are regular lumber punctures a feature of this trial?
The exclusion criteria is so vast that I think it cancels out many PPMS'ers.PPMS is one of those rare conditions that consultants will put you on at least one lymphocyte trafficking blockers just to assure themselves it is PPMS and not anything else.This means we PPMS'ers are between a rock and a hard place. It's not that we're complacent, more so we're not viable candidates for trial inclusion.
Re: "Are regular lumber punctures a feature of this trial?"No just a baseline diagnostic lumbar puncture.
Hurrah! I can comment. Thank you for making the change.Judy
Surely neuros can be a bit more proactive. Why not write to those with PPMS who look good candidates and let them know of the trial and the potential benefits.
Re: "Surely neuros can be a bit more proactive. Why not write to those with PPMS who look good candidates and let them know of the trial and the potential benefits."I agree. However, in fee-for-service healthcare systems, which the NHS is becoming, every patient that is referred into a clinical trial, which last 3 to 4 years or longer, is lost income. This creates a disincentive, therefore patients need to be more proactive about being referred into trials. Doc Cynic
Recent article was about enviromental impact of DMD syringes on the environment. I'd argue that the flights made by neuros to meetings / conference in different parts of the world is much more damaging. I saw that 9,000 neuros attended the AAN meeting in Hawaii (nice work if you can get it) earlier this year. Throw in ACTRIMS, ECTRIMS etc and it's a lot of fuel and cost. My organisation forces us to use video conferencing rather than making expensive journeys. Looks like the NHS hasn't experienced any cost cutting!
Re: "Environmental impact of meetings, etc…"I agree; it is a shocker and we need to consider the impact the current system of meetings is having. Things need to change and there are already some initiatives to do this, e.g. virtual meetings. However, environmental issues are a global problem and this should not detract from the problem of a world of used syringes, etc.
While there is something to be said for virtual meetings and video-conferencing, I believe that it is also important that researchers and neuros have the chance to meet and chat to each other, in order for there to be an ongoing process of exchanging thoughts and ideas. This can be done to some extent virtually, however, I'd hate for there be a complete elimination of personal contact as sometimes it's that element of a "chance" meeting or discussion with someone that can be very useful. And no, I'm not a neuro, researcher or any other health professional… just a joe bloggs with MS!