Uveitis Clinical Trial
Official title:
Efficacy, Safety and Cost-effectiveness of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis: a Randomized, Parallel 3 Arms, Active-controlled, Phase 3 Open Label With Blinded Outcome Assessment Study
Introduction: Non-infectious uveitis (NIUs) include a heterogeneous group of sight-threatening conditions. NIUs can be highly disabling and be associated with a profound impact in the quality-of-life (QoL) and wellbeing. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), which can be prescribed in monotherapy or in combination. Several observational studies have provided evidence that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet. Methods and analysis: The Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicenter, prospective, randomized, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate (MTX), adalimumab (ADA), or their combination in non-infectious non-anterior uveitis. The duration of the treatment and follow-up will last up to 52 weeks. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secundray measures of efficacy (QoL, visual acuity, costs) and safety, we will identify subjects' subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
| Active, not recruiting |
NCT04704609 -
Imaging Quantification of Inflammation (IQI)
|
||
| Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
| Withdrawn |
NCT01280669 -
Intravitreal Sirolimus as Therapeutic Approach to Uveitis
|
Phase 2 | |
| Terminated |
NCT02907814 -
Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
|
N/A | |
| Active, not recruiting |
NCT02252328 -
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT04183387 -
Simvastatin in Uveitis
|
Phase 2 | |
| Completed |
NCT01983488 -
Clinical Outcome in Uveitis
|
||
| Withdrawn |
NCT00499551 -
A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis
|
Phase 1/Phase 2 | |
| Terminated |
NCT00114062 -
Study to Treat Uveitis Associated Macular Edema
|
Phase 2 | |
| Completed |
NCT00132691 -
Multicenter Uveitis Steroid Treatment (MUST) Trial
|
Phase 4 | |
| Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
| Completed |
NCT00001867 -
Effect of Pregnancy on Uveitis
|
N/A | |
| Completed |
NCT00379275 -
Eye and Immunogenetic Features of Sarcoidosis
|
N/A | |
| Active, not recruiting |
NCT03828019 -
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
|
Phase 3 | |
| Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 | |
| Active, not recruiting |
NCT03889860 -
Objective Choroidal Thickness Measurements in Uveitis
|
||
| Completed |
NCT00070759 -
Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
|
Phase 2 | |
| Recruiting |
NCT05486468 -
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
|
Phase 3 | |
| Active, not recruiting |
NCT05385757 -
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
|