Head-to-Head trial tests biologics to save sight in stubborn uveitis
NCT ID NCT02929251
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested three biologic drugs—adalimumab, anakinra, and tocilizumab—in 112 people with severe, treatment-resistant uveitis, an inflammatory eye disease that can cause blindness. Participants received one of the drugs for 16 weeks. The goal was to see which drug best reduces eye inflammation while allowing lower steroid doses. This is the first randomized trial directly comparing these biologics for this condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adalimumab, anakinra, tocilizumab
- What this could lead to
- If successful, this study could identify the most effective biologic for severe uveitis, helping patients avoid blindness and reduce reliance on steroids.
- What could go wrong
- This is a phase 2 trial with only 112 participants, so results may not apply to all patients. Biologics can have serious side effects like infections, and the best drug may still fail to control inflammation in some cases.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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112 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Jan 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provide written, informed consent prior to the performance of any study specific procedures 2. Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature \[SUN\] criteria) of posterior, or pan- uveitis confirmed by documented medical history 3. Currently uncontrolled uveitic disease. Uncontrolled uveitic disease is defined as fulfilling one of the two following criteria at Inclusion: * Active inflammatory chorioretinal and/or inflammatory retinal vascular lesions and/or macular edema (CRT ≥300 microns) OR * Vitreous haze grade ≥4 on the Miami 9-step scale (or VH \>1+ according to SUN/NEI classification) 4. a. Patient who are receiving prednisone ≥10 mg/day and \<80mg/day (or equivalent dose of another corticosteroid) at stable dose 30 days prior to the first study drug administration on Day 0 and who received at least 1 other systemic immunosuppressant (All systemic immunosuppressants must have been discontinued 30 days prior to the first study drug administration on Day 0), or, b. Patient who received IFN alpha (All systemic immunosuppressants must have been discontinued 30 days prior to the first study drug administration on Day 0), or, c. To be intolerant to immunosuppressant 5. Best corrected visual acuity (BCVA) by ETDRS ≥ to 20/400 in either eye 6. Stable dose for two weeks prior to inclusion of topical corticosteroids and/or NSAIDs 7. Male or female , Age \>= 18 years at Inclusion 8. Weight 40 - 120 kg (88.2 - 264 lbs) at Inclusion 9. Chest X-ray or thoracic CT scan results (postero-anterior and lateral) within 12 weeks prior to Inclusion with no evidence of active Tuberculosis, active infection, or malignancy 10. For female subjects of child-bearing age, a negative serum or urine pregnancy test 11. For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 3 and 5 months after stopping therapy for roactemra and adalimumab, respectively. Birth control methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to CTFG recommendations). Such methods include : * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation 1: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system ( IUS) * bilateral tubal occlusion * vasectomised partner * sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). 12. A QuantiFERON®-Tuberculosis (TB) test within 6 months prior to Screening Exclusion Criteria: 1. Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted) 2. Isolated anterior uveitis 3. Presence of cataract or posterior capsular opacification so severe that an assessment of the posterior segment of either eye is inadequate or impossible 4. Contraindication to mydriasis in either eye or presence of posterior synechiae in the study eye such that mydriasis is inadequate for posterior segment examination 5. Intraocular pressure ≥ 25 mmHg by Goldmann tonometry or advanced glaucoma in either eye 6. Monocular patient 7. Active tuberculosis 8. Known positive syphilis serology, HIV antibody, hepatitis B surface antigen and/or anti-nucleocapsid antibody of hepatitis B virus and/or Hepatitis C virus, within 1 month prior to inclusion. 9. History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin. 10. History of severe allergic or anaphylactic reactions to monoclonal antibodies 11. Infectious disease: * Fever or infection requiring treatment with antibiotics within 3 weeks prior to Inclusion * History of recurrent infection or predisposition to infection 12. Known immunodeficiency 13. History of multiple sclerosis and/or demyelinating disorder 14. Laboratory values assessed during Inclusion: * Hemoglobin \< 8g/dL * White Blood Cell Count (WBC) \< 2.0 x 10\^3/mm3 * Platelet count \< 80 x 10\^3/mm3 * Glomerular filtration rates (GFR) \<30ml/min. * Transaminases \> 3 times upper normal value 15. Use of the following systemic treatments during the specified periods: * Any other previous systemic biologic therapy * Treatment with any systemic alkylating agents within 12 months prior to Inclusion or between Inclusion and Day 0 (e.g., cyclophosphamide, chlorambucil) * Any live (attenuated) vaccine within 3 months prior to Inclusion 16. Use of the following ocular treatments during the specified periods: * Previous anti Vascular Endothelial Growth Factor (VEGF) intravitreal therapy (applied to both eyes) within 3 months prior to Inclusion, or anticipated use during the study period * Treatment with dexamethasone intravitreal implant \[Ozurdex®\]) within 6 months prior to Inclusion * Intravitreal corticosteroids within 3 months prior to Inclusion. Previous Subtenon's corticosteroid injections are permitted if administered at least 2 months prior to Inclusion 17. Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHNO des Quinze Vingt
Paris, France
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CHNO des Quinze Vingt - Médecine interne
Paris, France
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CHNO des Quinze Vingt - Ophtalmologie
Paris, France
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CHRU de Nancy
Nancy, France
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CHRU de Nancy - Médecine interne
Nancy, France
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CHRU de Rennes Hopital Sud Médecine interne
Rennes, France
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CHU Clermont-Ferrand - Hopital Gabriel Montpied - Médecine interne
Clermont-Ferrand, France
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CHU Clermont-Ferrand - Hopital Gabriel Montpied - Ophtalmologie
Clermont-Ferrand, France
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CHU Dijon Bourgogne -Ophtalmologie
Dijon, France
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CHU Dijon Bourgogne Médecine Interne et Maladies Systémiques - Médecine 2 / SOC 2
Dijon, France
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CHU Rennes - Hopital Ponchaillou - Ophtalmologie
Rennes, France
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CHU Rouen - Hopital Charles Nicolle - Médecine interne
Rougé, France
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CHU Rouen - Hopital Charles Nicolle - Ophtalmologie
Rouen, France
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CHU TOULOUSE - HOPITAL PIERRE PAUL RIQUET - Ophtalmologie
Toulouse, France
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CHU Toulouse - Hopital Rangueil
Toulouse, France
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HCL - Hôpital de la Croix Rousse - Médecine interne
Lyon, France
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HCL - Hôpital de la Croix Rousse - Ophtalmologie
Lyon, France
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Hopital Avicenne - CRC
Bobigny, France
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Hopital Avicenne - Ophtalmologie
Bobigny, France
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Hopital Avicenne- Médecine interne
Bobigny, France
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Hopital Pellegrin
Bordeaux, France
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Hopital Pitié Salpetriere
Paris, France
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Hopital Rotchild - Médecine interne
Paris, France
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Hopital Rotchild - Ophtalmologie
Paris, France
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Hopital Saint André - Médecine interne
Bordeaux, France
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Hopital la pitié salpetriere - Médecine interne 1
Paris, paris, 75013, France
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Hôpital de la pitié salpêtrière - Ophtalmologie
Paris, France
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