NCT04798755

Efficacy, Safety and Costs of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Methotrexate	Inicial dose 15mg/week increasing up to 25 mg/week
DRUG	Adalimumab	At the Baselin visit adalimumab 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1.
DRUG	Adalimumab+Methotrexate	Adalimumab: at the Baseline visit 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1. Methotrexate:Inicial dose 15mg/week increasing up to 25 mg/week

Timeline

• Start date: 2022-01-12
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2021-03-15
• Last updated: 2023-09-21

Locations

14 sites across 1 country: Spain