Sunday, 12 February 2017

The Missing Data

Atacicept blocks BAFF and APRIL B cell growth factors and Makes MS Worse

Tabalumab (LY 2127399) is an anti-B-cell activating factor (BAFF) blocking (not APRIL) human monoclonal antibody designed for the treatment of autoimmune diseases and B cell malignancies.Tabalumab was developed by Eli Lilly and Company.

A phase III clinical trial for rheumatoid arthritis was halted in Feb 2013.In September 2014, a second phase III trial focussing on treating systemic lupus erythematosus, was terminated early as the study failed to meet its primary endpoint.

What happened in MS?

A Study of Patients With Relapsing Remitting Multiple NCT00882999 involving 245 people in 63 centres in USA and Europe.

They say the Study was Completed what happened?

Was it like atacicept and it made things worse? or did it not do nothing? It can't of worked or surely we would of heard.

Was it completed as said in June 2012 by the company or was it "Aborted" (the rest was written in German..does it mean completed) as linked to a comment by Norman Putzki (Biogen & Now Novartis).

FYI Qunitiles is a contract research organisation that monitors and co-ordinates trials
You sent a link to the Lily site that states

Lilly believes companies must act to earn the trust of the public they serve. To support this, Lilly supports responsible sharing of clinical study data and will continue to be an engaged partner in ongoing industry-wide discussions toward this goal.

Here are 7 ways in which we are committed to responsibly disclose our clinical trial data results for the benefit of patients and future research:

Whether favourable or unfavourable, Lilly posts the results of all Lilly-sponsored Phase II, Phase III and Phase IV clinical trials of Lilly marketed products conducted anywhere in the world that were initiated on or after October 15, 2002. I GUESS UNFAVOURABLE OR IT WOULD BE TALKED ABOUT......WAS IT MARKETED?

Results from all Phase III clinical trials and any clinical trial results of significant medical importance are submitted for publication. 

We don’t just do this for medicines that have met their clinical goals and been approved for use – we also disclose results for investigational medicines whose development have been discontinued.

We register all Lilly-sponsored Phase II, Phase III and Phase IV clinical studies, conducted anywhere in the world, that were initiated on or after October 15, 2002, on www.clinicaltrials.gov.

Lilly also registers all Phase I clinical studies commencing on or after October 1, 2010 on www.clinicaltrials.gov.

Lilly, along with the industry as a whole, has started posting results to the European database www.clinicaltrialsregister.eu. Our first results were submitted on 21 July 2015. We are updating results for trials conducted in the EU on our marketed products back to trials from 2004. This is a 2 year process and will be completed in 2016.

Lilly discloses results of Lilly-sponsored clinical trials for compounds whose development terminates on or after October 1, 2009.  FITS WITH THIS

This includes Lilly-sponsored Phase I clinical trials in patients that initiated on or after October 1, 2009 and Lilly-sponsored Phase I clinical trials in healthy volunteers that initiated on or after October 1, 2010.

We have an online portal to facilitate requests from legitimate researchers for clinical trial data here:www.clinicalstudydatarequest.com

HAD A GO ON THIS 
Enquiry 1683 - Tabalumab (LY2127399) in multiple sclerosis - Feasibility of providing data from studies of interest

Lilly is sharing data from clinical and interventional studies in patients for medicines and indications approved in the United States and the European Union. This study is not in scope for data sharing as tabalumab has not been approved as a treatment for any indication.
Kind Regards,
Data Sharing Team


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So went direct-Response
I received your request for the anonymized tabalumab data, and your request was discussed with a number of my Lilly colleagues. At this time, we have decided not to support the proposal. Please feel free to reach out to me if you have any questions.

Senior Medical Director, Biomedicines Core Team
Eli Lilly and Company


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245 people were reported to be involved in this trial. 

Don't they deserve to know what has happened?

There are over 60 sites across Europe and USA, somebody knows if it did nothing (maybe APRIL is what we need to focus on) or WORSE (then its BAFF).

I've reached out again



3 comments:

  1. Fear of publishing and admitting failure, either by the drug doing nothing positive against the disease or by the people involved have the disease aggravated during the trial ...

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  2. It's neither APRIL nor BAFF or they would be ringing our (and investors) ears full of jolly good news while the trials were still ongoing. My guess would be that it was a miserable fail and people got worse.

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  3. Re Eli Lilly site
    'We don’t just do this for medicines that have met their clinical goals and been approved for use – we also disclose results for investigational medicines whose development have been discontinued.'
    So just do it then! Honestly it's not difficult and it is wrong wrong wrong of you not to Eli Lilly :-(
    So best of luck MD with reaching out again and don't you just love all the corporate speak?
    If this fails is it worth a blog post asking if anyone remembers being in a trial in 2009? Failing that any good lawyers willing to volunteer services for free? Or go straight to the top?!


    ReplyDelete

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