Eligibility for clinical trials in primary Sjögren’s syndrome: lessons from the UK Primary Sjögren’s Syndrome Registry

Oni, Clare; Mitchell, Sheryl; James, Katherine; Ng, WF; Griffiths, Bridget; Hindmarsh,; Price, Elizabeth; Pease, CT; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michèle; Sutcliffe, Nurhan; Pitzalis, Costantino; Hunter, John; Gupta, Monica; McLaren, John; Cooper, AM; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, V.; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert J.; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, B; Rauz, Saaeha; Richards, Andrea; Bowman, S

doi:10.1093/rheumatology/kex331

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Lack Of Consistency Between Studies In the Efficacy Of Ritux1

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“…There is also a difficulty in applying strict inclusion criteria when recruiting eligible patients for trials. For example, Oni et al (25) showed that when applying specific outcome measures, such as an ESSPRI score of $5 and an ESSDAI score of $5, with requirements for unstimulated whole saliva flow greater than zero and anti-Ro positivity, the pool of eligible participants will be greatly reduced. However, if the inclusion criteria are too general, the result will be a failing trial unless the biologic agent tested has such a general beneficial action that it is effective in most subcategories of patients with primary SS.…”

Section: Lack Of Consistency Between Studies In the Efficacy Of Rituxmentioning

confidence: 99%