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Navidea Biopharmaceuticals, Inc.
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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-respondersACR responses to anti-TNF therapiesThe 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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