50th Participant Enrolled in Phase 3 RA trial:responder timing critical to reach.. | NAVB Message Board Posts


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Msg  38584 of 38847  at  11/28/2022 9:09:35 PM  by

moneyonomics

The following message was updated on 11/29/2022 11:32:18 AM.

 In response to msg 38578 by  FIRAC
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Re:50th Participant Enrolled in Phase 3 RA trial:responder timing critical to reach..

           
100 responder target below asap per guidance
 
My take
-ACR50 is 3-33 trial yardstick
-25% to 42% range is ACR50 responders to anti TNF-a therapy from research below
-non-responder range would then extrapolate to 58% to 75% so should statistically be obtained faster and surpass responders in 3-33 trial, if all participants walk in the door equally and randomly dispersed 
-so trial size could range from 240 to 400 to obtain 100 responders 
-which is what I interpret Dr Rosol shared in CC as mid range
So need responders to show up faster/non equally dispersed at front end by demographics focus to reduce overall trial size and still meet 100 guidance .....
 
Press Release
"This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis (“RA”) patients switching to an anti-TNFα therapy, addressing a large unmet medical need. Overall trial size will range from 198-672 patients, to achieve a minimum of 100 clinical responders to anti-TNFα therapy and 98 non-responders." 
 
 RESEARCH

Defining response to TNF-inhibitors in rheumatoid arthritis: the negative impact of anti-TNF cycling and the need for a personalized medicine approach to identify primary non-responders

 
 
 

ACR responses to anti-TNF therapies

The ACR20, ACR50, and ACR70 responses of patients with RA treated with anti-TNF drugs were reviewed by Chung et al. [49], and Scott [58] and are summarized in Table 3. Taken together, these data indicate ACR50 is an attainable target for patients with RA and can be maintained for at least 3 years [59]. Unfortunately, only 25–42% of patients reach the treatment target of ACR50 (Table 3). This agrees with the percentage of patients estimated to obtain ACR20, 50 and 70 responses to these drugs at week 24 of treatment: ACR20, 13–46%; ACR50, 11–38%; ACR70, 8–20% [48] (Table 3).

 
 

 

 

 

 

 

 

 

 

 

 


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