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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 58 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01900431
The ClinicalTrials.gov registry entry for NCT01900431 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT01900431 reports 0 study locations.
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.
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