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Status of Rituximab-ME/CFS Studies

Discussion in 'Rituximab: News and Research' started by Persimmon, Feb 15, 2012.

  1. satoshikasumi

    satoshikasumi Senior Member

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    A Roche sponsored study is coming, and Roche is already paying for some of the open-label work that is being done now. However, as the Rituxan patent expires in 2015, Roche does not have the financial incentive to do the full-scale clinical trials that would lead to regulatory approval. It is likely to be something smaller, done in cooperation with several charities. Details have not been worked out yet, but several prominent doctors in the US are working with the company on this.
     
  2. sensing progress

    sensing progress Senior Member

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    Source.....?
     
  3. satoshikasumi

    satoshikasumi Senior Member

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    Can't tell you that. You'll just have to believe me.
     
  4. SpecialK82

    SpecialK82 Senior Member

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    Thanks so much Wally and LHCTom for your input as patients of Dr. Kogelnik. Very informative :)
     
  5. Kati

    Kati Patient in training

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    i wanted to let people know that I will have my first Rituxan treatment on April 10th and will blogging every step of the way over here: http://bikechick06.blogspot.ca/
     
    merylg, ahimsa and Roy S like this.
  6. Snow Leopard

    Snow Leopard Senior Member

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    Thanks Kati and good luck.
     
    Kati likes this.
  7. Chris

    Chris Senior Member

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    Kati, good luck, and glad you will keep us posted! Best, Chris
     
    Kati likes this.
  8. Ember

    Ember Senior Member

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    Congratulations, Kati!:victory:
     
    Kati likes this.
  9. SpecialK82

    SpecialK82 Senior Member

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    Kati - very, very exciting!!

    Thank you so much for keeping us posted, I will be watching your blog and praying for you - please let this be the answer.
     
    Kati likes this.
  10. sprankel

    sprankel

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    Good luck!
     
  11. Kati

    Kati Patient in training

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    Thank you so much for your support everyone! It is my pleasure to share my experience and I am really looking forward
    to it!
     
  12. Wally

    Wally Senior Member

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    Kati,

    Thank you so much for sharing your experiences and knowledge regarding the Riuxan pilot study with Dr. Kogelnik. I have also just started reading your blog (from the beginning) and I am thoroughly enjoying all the biking, travel and CFS stories.

    I was wondering if I could ask for your help in providing the correct information about the number of infusions and the length of time that you are going to be involved in the Rituxan study. I had posted earlier that I thought there were going to be 5 or 6 infusions with the study period lasting about 18 months. I unfortunately I added this information without double checking to see if my often cognitively challenged memory was accurate.:(

    Last night while trying to organize a pile of lab records/doctor visit notes and research references, I came across some notes that I had made from an appointment with Dr. Kogelnik from over a year ago where we discussed the Rituxan trial. I had written down that the trial was to last for 6 months and there were to be four infusions with the first two infusions two weeks apart and then a scribbled note referencing 18 months. I had also written a separate note that some other Rituxan studies had 5 to 6 infusions over an 18 month period, I believe this note was a reference to some general on-line research that I had done about Rituxan. I now realize that some of the information I added to this Rituxan thread may include some inaccurate information and I would like to edit out anything in my post that is incorrect.

    Wally
     
  13. SOC

    SOC Senior Member

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    Best wishes, Kati!

    As a community, we are fortunate to have someone with your professional experience administering Rituximab reporting on your experience as an ME/CFS patient. I look forward to reading your reports. Thank you.
     
  14. Kati

    Kati Patient in training

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    Wally, I am really glad you are enjoying the reading! And I am really glad I made all of my bike trips before illness struck. They are an unlimited ( well for now anyways) of great memories!

    Your information in regards to the number of treatment may just be dated. I haven't personally asked the number of treatments I would get, since I believe that things will evolve. See, Dr K is in contact with Dr Mella and Fluge twice a month so they are constantly refining the protocol according to what they see in clinic. So I learnt that they moved their maintenance doses from every 3-4 months to every 2-3 months now. Apparently the patients can tell when it's time for more. This piece of info is fascinating to me and I am looking forward to experience it myself. They are probably (my best guess) planning the protocol for multi-center clinical trial. I also guess that Dr Mella and Fluge will update at the incoming London Invest in ME. Also note that Dr K has also been invited to speak again.

    So I am going to San Francisco with an open mind and hopeful heart. We will make decisions as we go along. After all, it is all experimental.
     
    merylg likes this.
  15. Wally

    Wally Senior Member

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    Kati,

    Thanks so much for responding back to my inquiry. I know that physicians often are not in a position to publicly release information while a study is ongoing, so I knew it would be better for the information to come from a patient currently enrolled in the study. It is great that we have the internet to communicate with each other, but I have learned my lesson to be extra careful when posting information directly from my own internal hard drive. :headache:

    Wally :cool:
     
  16. Kati

    Kati Patient in training

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    Hey Wally, let it be clear that I am not part of a study. It's a pilot, or 1 person trial.

    Clinical trials are usually very regulated and there are protocols for all kinds of issues, like what to do if the patient has a major infection. They grade side effects from 1 (mild) to 4 (severe) and you need to sign consent. They usually have strict inclusion and exclusion rules. No rules can be bent.

    I'm just one of the guinea pigs before the clinical trials...:rolleyes:
     
    merylg likes this.
  17. Wally

    Wally Senior Member

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    Kati,

    Yes, yes, I had been trying to be so careful to use study not trial. Mea culpa!! This is definitely a pilot study not a trial. Glad you pointed that out again. I think there has been a lot of confusion over what is a clinical trial and what is a pilot study. Would you be able to articulate the difference, so this is clear to anyone who is reading this thread? I do not want to take a chance that my attempt at a definition will end up in a tangled mess. :eek:

    Wally
     
  18. Kati

    Kati Patient in training

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    Here is a paper on pilot studies :angel:

    http://www.biomedcentral.com/content/pdf/1471-2288-10-1.pdf

    Abstract
    Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as feasibility or vanguard studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and poten- tially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and mis- conceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked ques- tions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.

    And here is info about clinical trials, from clinicaltrials.gov


    What is a clinical trial?

    Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.


    Why participate in a clinical trial?

    Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.


    Who can participate in a clinical trial?

    All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.


    What happens during a clinical trial?

    The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

    Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
     
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  19. taniaaust1

    taniaaust1

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    Thanks Kati. Im looking forward to reading your blog
     
  20. Cort

    Cort Phoenix Rising Founder

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    merylg and sensing progress like this.

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