Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01900431 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT01900431: Completed Phase 2 study, sponsored by Sanofi.
NCT01900431 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01900431, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU). Secondary Objectives: To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy. To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).
Primary Outcome
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 \[low opacity\] to 8 \[more opacity\]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose \<10 mg/day (or equivalent oral corticosteroid) were also e
Interventions
- DRUG Prednisone
- DRUG Methotrexate
- DRUG Sarilumab
- DRUG Folic/folinic acid
- OTHER Placebo (for Sarilumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01900431 record still lists
NCT01900431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT01900431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01900431 about?
NCT01900431 is a clinical study titled "Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis". Primary Objective: To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU). Secondary Objectives: To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the ch...
What is the current status of trial NCT01900431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2013-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01900431?
The interventions under investigation include: Prednisone (DRUG), Methotrexate (DRUG), Sarilumab (DRUG), Folic/folinic acid (DRUG), Placebo (for Sarilumab) (OTHER).
Who is sponsoring clinical trial NCT01900431?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01900431's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03587844 · 58 participants · Phase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
- NCT03630991 · 58 participants · Phase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
- NCT03949855 · 58 participants · Phase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
- NCT04069273 · 58 participants · Phase 2
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia