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NCT02929251: RUBI
Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis
Phase 2 trial testing Anakinra in Uveitis in 112 participants. Completed in 29 January 2022.
29 October 2021
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 29 June 2017 |
| Primary completion | 29 October 2021 |
| Estimated completion | 29 January 2022 |
| Sites | 27 locations across France |
Drugs / interventions tested
- Anakinra (ANAKINRA) — full drug profile →
- Tocilizumab (tocilizumab) — full drug profile →
- Adalimumab (ADALIMUMAB) — full drug profile →
Conditions studied
- Uveitis — all drugs for Uveitis →
- Biotherapy — all drugs for Biotherapy →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Uveitis or Biotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Review of Recent Advances Using Tocilizumab in the Treatment of Rheumatic Diseases.
Rubbert-Roth A, Furst DE, Nebesky JM, Jin A, et al · · 2018 · cited 80× · PMID 29502236 · DOI 10.1007/s40744-018-0102-x -
Adalimumab, Anakinra, and Tocilizumab in Patients With Noninfectious Uveitis: A Multicenter Randomized Controlled Trial.
Saadoun D, Ghembaza A, Touhami S, Girszyn N, et al · · 2026 · PMID 41643758 · DOI 10.1016/j.ajo.2026.01.037
Verify or expand the search:
- PubMed search for NCT02929251
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06666335 — A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF · Phase 4 · not yet recruiting
- NCT06697431 — Non Inferiority KawasakI Trial With Anakinra · Phase 4 · not yet recruiting
Other recruiting trials for Uveitis
Currently open trials in the same condition.
- NCT07262437 — Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles · NA · active not recruiting
- NCT07176130 — Demographics and Clinical Characteristics of Ocular Inflammatory Diseases in Singapore · active not recruiting
- NCT06974162 — Metagenomics for Ocular Inflammation · recruiting
- NCT06431373 — A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis · Phase 3 · active not recruiting
- NCT06310837 — Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis · NA · active not recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02929251 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02929251.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing