Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT02929251
Phase
PHASE2
Status
Completed

Conditions

  • Biotherapy
  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anakinra — DRUG
    Anakinra (100 mg/day subcutaneously) (n=40) for 16 weeks
  • Tocilizumab — DRUG
    Tocilizumab (162 mg/7 days subcutaneously) (n=40) for 16 weeks.
  • Adalimumab — DRUG
    Adalimumab (40mg/14 days subcutaneously) (n=40) for 16 weeks

Study Details

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.

Key Dates

Start date
Jun 29, 2017
Status verified
Jun 2024
Primary completion
Oct 29, 2021
Completion
Jan 29, 2022

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab
    Adalimumab (40mg/14 days subcutaneously) (n=40) for 16 weeks
  • Experimental: Anakinra
    Anakinra (100 mg/day subcutaneously) (n=40) for 16 weeks
  • Experimental: Tocilizumab
    Tocilizumab (162 mg/7 days subcutaneously) (n=40) for 16 weeks.

Primary Outcome Measure

Percentage of patients with at least 2-step reduction in Vitreous Haze (according to Miami 9-step Scale) and with a dose <= 0.1 mg/Kg/day of prednisone (or equivalent oral corticosteroid) [ Time Frame: Week 16 ]

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