Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis
Status:
Unknown status
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either
anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm
evidence or randomized controlled trials directly addressing the best biologic agent in
severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal
blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission
over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been
dramatically reduced in the recent years with the use of biologics, raising the question of
whether these compounds should be used earlier in the treatment of severe non infectious
uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly
effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma.
Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees
the innovative nature of this study that aims selecting or dropping any arm when evidence of
efficacy already exists.
Phase:
Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Adalimumab Interleukin 1 Receptor Antagonist Protein