Monday, November 24, 2008

New Phase-II clinical trial: Abatacept

I'm in the process of adding a new human trial to my list of clinical trials aimed at curing type-1 diabetes. This is a phase-II trial of Abatacept, a drug already approved for rheumatoid arthritis. It is a honeymoon treatment. The hope is by giving this drug early in the process, some insulin production can be preserved, or (if that fails) the honeymoon phase can be extended.

This drug is already approved for use on rheumatoid arthritis (in certain situations), and is currently part of many human trials for several different "self immunity" based diseases such as Psoriasis Vulgaris, Asthma, Scleroderma, Ulcerative Colitis, Lupus, Multiple Sclerosism and Graft or Organ Rejection.

Unfortunately, there was no phase-I trial targeting type-1 diabetes for this drug, so there is no data on it's effectiveness against type-1 diabetes. Since it was already approved for use in people, they could skip the phase-I trial because the drug's safety was already known. It did prevent diabetes from developing in NOD mice.

Estimated Enrollment: 108
Study Start Date: February 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Sponsors include several US government agencies (NIDDK, NIAID, and NICHD) , JDRF and ADA.

The ClinicalTrial record for this study is:
Wikipedia has general article on Abatacept:
TrialNet's record for this trial is here:

This study is recruiting people right now. The first requirement is that you be within 100 days of diagnosis. You can get more information from TrialNet (link above) or by calling 800-HALT-DM1 (1-800-425-8361). It is being run out of 15 different US sites, and a couple of sites in other countries. For the locals: both UCSF and Stanford are trial sites.

The primary investigator is Orban, out of the Joslin center. The same guy who took Faustman's research in a different direction. I think he has the distinction of being the only guy with two different human trials to try to cure type-1 diabetes active at the same time, or almost the same time. He must be one busy dude.


1 comment:

Tihamer Orban MD. MRCPCH. said...

The trial is done and half of the insulin production after 2 year been saved.
Check the Lancet paper.
Tihamer Orban MD